Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02571777
Recruitment Status : Completed
First Posted : October 8, 2015
Results First Posted : July 22, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: QVM149 150/50/160
Drug: QVM149 150/50/80
Drug: QMF149 150/320
Drug: QMF149 150/160
Drug: salmeterol/fluticasone
Enrollment 3092
Recruitment Details Participants took part in 415 investigative sites in 41 countries
Pre-assignment Details 4851 participants were screened of which 3092 participants were randomized to 1 of the 5 treatment groups with a randomization ratio of 1:1:1:1:1.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Period Title: Overall Study
Started [1] 619 620 618 617 618
Full Analysis Set (FAS) [2] 615 616 611 607 612
Safety Set (SAF) [3] 616 617 613 608 618
Completed 580 582 577 580 582
Not Completed 39 38 41 37 36
Reason Not Completed
Subject/guardian decision             34             26             26             25             27
Protocol Deviation             2             3             4             8             4
Death             1             1             4             0             0
Lost to Follow-up             1             1             2             0             1
Physician Decision             1             7             5             2             4
Pregnancy             0             0             0             2             0
[1]
All patients who were assigned a randomization number
[2]
All patients in the randomization set who received at least one dose of study medication
[3]
All patients who received at least one dose of study medication whether or not being randomized
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d. Total
Hide Arm/Group Description QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler® Total of all reporting groups
Overall Number of Baseline Participants 619 620 618 617 618 3092
Hide Baseline Analysis Population Description
Randomized Set (RAN) consisted of all participants who were assigned a randomization number, regardless of whether or not they actually received study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 619 participants 620 participants 618 participants 617 participants 618 participants 3092 participants
52.1  (12.91) 52.4  (12.71) 52.0  (12.81) 51.8  (12.86) 52.9  (12.23) 52.2  (12.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 619 participants 620 participants 618 participants 617 participants 618 participants 3092 participants
Female
381
  61.6%
362
  58.4%
380
  61.5%
378
  61.3%
417
  67.5%
1918
  62.0%
Male
238
  38.4%
258
  41.6%
238
  38.5%
239
  38.7%
201
  32.5%
1174
  38.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 619 participants 620 participants 618 participants 617 participants 618 participants 3092 participants
Caucasian
456
  73.7%
458
  73.9%
453
  73.3%
452
  73.3%
468
  75.7%
2287
  74.0%
Black
4
   0.6%
5
   0.8%
3
   0.5%
4
   0.6%
1
   0.2%
17
   0.5%
Asian
139
  22.5%
133
  21.5%
133
  21.5%
135
  21.9%
131
  21.2%
671
  21.7%
Native American
7
   1.1%
8
   1.3%
8
   1.3%
4
   0.6%
5
   0.8%
32
   1.0%
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
0
   0.0%
1
   0.0%
Other
13
   2.1%
16
   2.6%
21
   3.4%
21
   3.4%
13
   2.1%
84
   2.7%
1.Primary Outcome
Title Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus QMF149 at Week 26
Hide Description

Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.

The primary endpoint considered the following 2 comparison groups:

  • QVM149 150/50/80 μg o.d. compared with QMF149 150/160 μg o.d. both delivered via Concept1
  • QVM149 150/50/160 μg o.d. compared with QMF149 150/320 μg o.d. both delivered via Concept1.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with a valid measurement for the outcome measure.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 614 614 606 602 607
Least Squares Mean (Standard Error)
Unit of Measure: litre (L)
2.050  (0.0128) 2.029  (0.0129) 1.984  (0.0129) 1.953  (0.0130) 1.930  (0.0131)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Model for Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.065
Confidence Interval (2-Sided) 95%
0.031 to 0.099
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0176
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.076
Confidence Interval (2-Sided) 95%
0.041 to 0.111
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0176
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Asthma Control Questionnaire (ACQ-7) at Week 26 and Week 52
Hide Description The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The ACQ-7 total score reported below was calculated as the mean of scores of all 7 items and ranged between 0 and 6, with higher scores indicating worse asthma symptom control.
Time Frame 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with a valid measurement for the outcome measure.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 607 595 596 598 599
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
Week 26 Number Analyzed 566 participants 559 participants 562 participants 559 participants 562 participants
1.542  (0.0329) 1.543  (0.0330) 1.528  (0.0329) 1.614  (0.0331) 1.628  (0.0329)
Week 52 Number Analyzed 552 participants 537 participants 547 participants 536 participants 547 participants
1.406  (0.0334) 1.535  (0.0337) 1.465  (0.0335) 1.545  (0.0338) 1.527  (0.0335)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.729
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.014
Confidence Interval (2-Sided) 95%
-0.066 to 0.094
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0406
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.086
Confidence Interval (2-Sided) 95%
-0.165 to -0.006
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0404
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.071
Confidence Interval (2-Sided) 95%
-0.151 to 0.010
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0409
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.084
Confidence Interval (2-Sided) 95%
-0.164 to -0.005
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0406
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.157
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.059
Confidence Interval (2-Sided) 95%
-0.140 to 0.023
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0415
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.121
Confidence Interval (2-Sided) 95%
-0.202 to -0.040
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0414
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.814
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.010
Confidence Interval (2-Sided) 95%
-0.092 to 0.072
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0420
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.845
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.008
Confidence Interval (2-Sided) 95%
-0.073 to 0.090
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0416
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Trough Forced Expiratory Volume in 1 Second (Trough FEV1) of QVM149 Versus Salmeterol/Fluticasone at Week 26
Hide Description

Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.

This secondary endpoint considered the following 2 comparison groups:

  • QVM149 150/50/80 μg o.d. via Concept1 compared with salmeterol/fluticasone 50/500 μg b.i.d. via Accuhaler®
  • QVM149 150/50/160 μg o.d. via Concept 1 compared with salmeterol/fluticasone 50/500 μg b.i.d. via Accuhaler®
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with a valid measurement for the outcome measure.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 614 614 606 602 607
Least Squares Mean (Standard Error)
Unit of Measure: litre (L)
2.050  (0.0128) 2.029  (0.0129) 1.984  (0.0129) 1.953  (0.0130) 1.930  (0.0131)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.119
Confidence Interval (2-Sided) 95%
0.085 to 0.154
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0177
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.099
Confidence Interval (2-Sided) 95%
0.064 to 0.133
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0177
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Trough FEV1 at Week 52
Hide Description Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with a valid measurement for the outcome measure.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 614 614 606 602 607
Least Squares Mean (Standard Error)
Unit of Measure: litre (L)
2.050  (0.0129) 1.992  (0.0130) 1.965  (0.0130) 1.930  (0.0130) 1.905  (0.0132)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.086
Confidence Interval (2-Sided) 95%
0.051 to 0.120
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0176
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.145
Confidence Interval (2-Sided) 95%
0.111 to 0.180
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0178
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.062
Confidence Interval (2-Sided) 95%
0.027 to 0.096
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0178
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.087
Confidence Interval (2-Sided) 95%
0.052 to 0.122
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0179
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Pre-dose Forced Vital Capacity (FVC) at Week 4 and Week 12
Hide Description Pre-dose FVC is defined as average of the two FVC measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FVC is the total amount of air exhaled during the FEV test.
Time Frame 4 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with a valid measurement for the outcome measure.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 606 594 592 596 598
Least Squares Mean (Standard Error)
Unit of Measure: litre (L)
Week 4 Number Analyzed 598 participants 573 participants 573 participants 579 participants 577 participants
3.091  (0.0161) 3.059  (0.0163) 3.018  (0.0163) 3.020  (0.0163) 2.952  (0.0163)
Week 12 Number Analyzed 580 participants 569 participants 573 participants 562 participants 568 participants
3.067  (0.0162) 3.065  (0.0164) 3.011  (0.0163) 3.014  (0.0164) 2.965  (0.0163)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.073
Confidence Interval (2-Sided) 95%
0.030 to 0.116
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0218
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.139
Confidence Interval (2-Sided) 95%
0.096 to 0.181
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0217
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.074
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.039
Confidence Interval (2-Sided) 95%
-0.004 to 0.082
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0220
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.108
Confidence Interval (2-Sided) 95%
0.065 to 0.150
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0219
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.056
Confidence Interval (2-Sided) 95%
0.014 to 0.099
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0219
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.102
Confidence Interval (2-Sided) 95%
0.059 to 0.145
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0218
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.050
Confidence Interval (2-Sided) 95%
0.007 to 0.094
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0221
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.099
Confidence Interval (2-Sided) 95%
0.056 to 0.142
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0220
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Trough Forced Expiratory Flow (FEF) Between 25% and 75% of FVC (FEF25-75) at 52 Weeks
Hide Description FEF is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Trough FEF25-75% is defined as average of the two FEF25-75% measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with a valid measurement for the outcome measure.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 614 614 606 602 607
Least Squares Mean (Standard Error)
Unit of Measure: L/s
1.354  (0.0190) 1.263  (0.0192) 1.260  (0.0191) 1.214  (0.0192) 1.207  (0.0194)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.095
Confidence Interval (2-Sided) 95%
0.045 to 0.145
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0254
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.147
Confidence Interval (2-Sided) 95%
0.097 to 0.198
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0256
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.049
Confidence Interval (2-Sided) 95%
-0.001 to 0.099
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0256
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.056
Confidence Interval (2-Sided) 95%
0.006 to 0.107
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0258
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
Hide Description PEF is a person's maximum speed of expiration. All the participants were instructed to record PEF twice daily using a mini Peak Flow Meter device, once in the morning (before taking the morning dose) and once approximately 12 h later in the evening (before taking the evening dose) at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the e-PEF/diary. The best of 3 values were used.
Time Frame Baseline, 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with a valid measurement for the outcome measure.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 596 584 581 584 586
Least Squares Mean (Standard Error)
Unit of Measure: L/min
Week 26 - Mean morning PEF Number Analyzed 596 participants 583 participants 581 participants 584 participants 584 participants
47.7  (1.93) 40.5  (1.95) 29.5  (1.95) 25.6  (1.95) 12.5  (1.95)
Week 26 - Mean evening PEF Number Analyzed 594 participants 584 participants 580 participants 578 participants 577 participants
39.6  (1.87) 34.7  (1.88) 22.8  (1.88) 20.6  (1.89) 10.4  (1.89)
Week 52 - Mean morning PEF Number Analyzed 596 participants 584 participants 581 participants 583 participants 586 participants
47.5  (2.03) 41.2  (2.05) 28.8  (2.05) 25.6  (2.06) 12.7  (2.05)
Week 52 - Mean evening PEF Number Analyzed 593 participants 577 participants 578 participants 576 participants 578 participants
38.7  (1.97) 35.0  (1.99) 21.2  (1.99) 20.1  (2.00) 9.2  (1.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Week 26 - Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Linear Mixed Model (LMM)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 18.2
Confidence Interval (2-Sided) 95%
13.2 to 23.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 26 - Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 35.3
Confidence Interval (2-Sided) 95%
30.2 to 40.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Week 26 - Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 14.9
Confidence Interval (2-Sided) 95%
9.8 to 20.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 26 - Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 28.0
Confidence Interval (2-Sided) 95%
22.9 to 33.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Week 26 - Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 16.8
Confidence Interval (2-Sided) 95%
11.8 to 21.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 26 - Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 29.1
Confidence Interval (2-Sided) 95%
24.2 to 34.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Week 26 - Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 14.1
Confidence Interval (2-Sided) 95%
9.1 to 19.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 26 - Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 24.3
Confidence Interval (2-Sided) 95%
19.3 to 29.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Week 52 - Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 18.7
Confidence Interval (2-Sided) 95%
13.4 to 24.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 52 - Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 34.8
Confidence Interval (2-Sided) 95%
29.5 to 40.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Week 52 - Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 15.6
Confidence Interval (2-Sided) 95%
10.2 to 20.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 52 - Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 28.5
Confidence Interval (2-Sided) 95%
23.2 to 33.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Week 52 - Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 17.5
Confidence Interval (2-Sided) 95%
12.3 to 22.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 52 - Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 29.5
Confidence Interval (2-Sided) 95%
24.2 to 34.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Week 52 - Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 15.0
Confidence Interval (2-Sided) 95%
9.7 to 20.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 52 - Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 25.8
Confidence Interval (2-Sided) 95%
20.5 to 31.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.68
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Percentage of Asthma Symptom-free Days Over 52 Weeks
Hide Description All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. Asthma symptoms free days are days with no daytime symptoms, no night-time awakenings and no symptoms on awakening. The daytime asthma symptom score was based on the daily e-diary recordings by participants with respect to shortness of breath, wheeze, cough, chest tightness, and impact on usual daily activities due to symptoms.
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with a valid measurement for the outcome measure.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 566 552 559 554 558
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of days
22.4  (1.35) 18.0  (1.36) 22.2  (1.36) 18.0  (1.37) 18.9  (1.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.907
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-3.3 to 3.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
-0.1 to 7.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.997
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-3.6 to 3.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.606
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-4.5 to 2.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.82
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Percentage of Days With no Daytime Symptoms Over 52 Weeks
Hide Description All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. For days with no daytime symptoms, all 5 evening questions must have a score = 0 with respect to shortness of breath, wheeze, cough, chest tightness and impact on usual daily activities due to symptoms, each with scores from 0 (no problems) to 4 (very severe problems).
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with a valid measurement for the outcome measure.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 594 577 579 579 578
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of days
22.5  (1.32) 17.9  (1.34) 21.8  (1.33) 18.0  (1.34) 18.8  (1.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.712
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-2.8 to 4.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 3.7
Confidence Interval (2-Sided) 95%
0.2 to 7.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.943
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-3.7 to 3.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.612
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-4.4 to 2.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.79
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Percentage of Nights With no Night-time Awakenings Over 52 Weeks
Hide Description All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems).
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with a valid measurement for the outcome measure.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 599 584 582 584 586
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of days
18.0  (1.11) 17.6  (1.12) 18.4  (1.13) 16.1  (1.13) 16.9  (1.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.809
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-3.3 to 2.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.467
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-1.9 to 4.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.318
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
-1.5 to 4.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.640
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-2.3 to 3.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.51
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Percentage of Mornings With no Symptoms on Rising Over 52 Weeks
Hide Description All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems).
Time Frame Baseline, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with a valid measurement for the outcome measure.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 599 584 582 584 586
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of days
19.5  (1.33) 18.5  (1.35) 19.9  (1.35) 15.5  (1.35) 15.6  (1.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.814
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-4.0 to 3.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 3.8
Confidence Interval (2-Sided) 95%
0.2 to 7.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
-0.6 to 6.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-0.7 to 6.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.84
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Percentage of Days Without Rescue Medication Use Over 26 and 52 Weeks
Hide Description Percentage of days without rescue medication usage (100 μg salbutamol/90 μg albuterol via metered-dose inhaler) as recorded by e-diary over 26 and 52 weeks of treatment.
Time Frame Baseline, 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with a valid measurement for the outcome measure.
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 590 577 578 580 579
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of days
Week 26 Number Analyzed 590 participants 577 participants 578 participants 580 participants 579 participants
22.5  (1.32) 19.5  (1.33) 23.3  (1.33) 18.2  (1.33) 19.6  (1.33)
Week 52 Number Analyzed 583 participants 574 participants 576 participants 576 participants 578 participants
25.0  (1.36) 21.9  (1.36) 24.9  (1.36) 20.8  (1.37) 21.8  (1.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.645
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-4.2 to 2.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-0.5 to 6.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.460
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-2.1 to 4.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.971
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-3.5 to 3.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.963
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-3.4 to 3.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
-0.3 to 6.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.517
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-2.3 to 4.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.956
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-3.4 to 3.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.78
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Patients Achieving the Minimal Clinically Important Difference (MCID) ACQ ≥ 0.5 at Week 26 and Week 52
Hide Description Change from baseline in ACQ-7 scores of ≤ 0.5 was defined as minimal clinically important difference and were considered clinically meaningful. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions.
Time Frame 26 weeks, 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 615 616 611 607 612
Measure Type: Number
Unit of Measure: Percentage of participants
Week 26 Number Analyzed 566 participants 559 participants 562 participants 559 participants 562 participants
71.2 71.7 74.2 70.7 67.4
Week 52 Number Analyzed 552 participants 537 participants 547 participants 536 participants 547 participants
78.8 72.8 77.9 73.1 72.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.535
Comments [Not Specified]
Method Logistic regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.70 to 1.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments [Not Specified]
Method Logistic regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.93 to 1.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.380
Comments [Not Specified]
Method Logistic regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.86 to 1.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.172
Comments [Not Specified]
Method Logistic regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
0.92 to 1.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.510
Comments [Not Specified]
Method Logistic regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.83 to 1.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Logistic regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.06 to 1.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.744
Comments [Not Specified]
Method Logistic regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.79 to 1.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.922
Comments [Not Specified]
Method Logistic regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.75 to 1.29
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Time to First Hospitalization for Asthma Exacerbation
Hide Description Time from start of treatment until the first event (hospitalization for asthma exacerbation) or censoring. Patients without the event were considered as censored at the date of last treatment + 1 day. For patients having the event, the start date of the hospitalization was considered to calculate the time to event (i.e., the number of days from start of treatment up to the event start date).
Time Frame 52 weeks on average, up to 416 days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 615 616 611 607 612
Median (Full Range)
Unit of Measure: days
367.0
(2 to 416)
367.0
(2 to 396)
367.0
(1 to 411)
367.0
(1 to 408)
367.0
(1 to 416)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.371
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
0.27 to 1.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.996
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.37 to 2.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.145
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.89
Confidence Interval (2-Sided) 95%
0.80 to 4.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
0.80 to 4.43
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Time to First Asthma Exacerbation by Exacerbation Category
Hide Description

Time from start of treatment until the first event (asthma exacerbation) or censoring. Patients without the event were considered as censored at the date of last treatment + 1 day. For patients having the event, the start date of the exacerbation was considered to calculate the time to event (i.e., the number of days from start of treatment up to the event start date).

The exacerbation categories were: All (mild, moderate and severe), combination of moderate or severe and severe.

Time Frame 52 weeks on average, up to 416 days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 615 616 611 607 612
Median (Full Range)
Unit of Measure: days
Moderate or severe asthma exacerbation
366.0
(2 to 416)
366.0
(2 to 396)
366.0
(1 to 411)
365.0
(1 to 387)
365.0
(1 to 416)
Severe asthma exacerbation
366.0
(2 to 416)
366.0
(2 to 396)
366.0
(1 to 411)
366.0
(1 to 389)
366.0
(1 to 416)
All (mild, moderate or severe) asthma exacerbation
363.0
(2 to 416)
364.0
(2 to 396)
361.0
(1 to 411)
360.0
(1 to 384)
278.0
(1 to 416)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Moderate or severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.523
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.77 to 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Moderate or severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.58 to 0.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Moderate or severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.72 to 1.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Moderate or severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.63 to 0.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.476
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.72 to 1.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.54 to 0.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.243
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.70 to 1.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.63 to 0.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments All (mild, moderate, severe) asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.497
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.79 to 1.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments All (mild, moderate, severe) asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.60 to 0.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments All (mild, moderate, severe) asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.126
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.73 to 1.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments All (mild, moderate, severe) asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.61 to 0.85
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Annual Rate of Asthma Exacerbations by Exacerbation Category
Hide Description The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title QVM149 150/50/160 µg o.d. QVM149 150/50/80 µg o.d. QMF149 150/320 µg o.d. QMF149 150/160 µg o.d. Salmeterol/Fluticasone 50/500 μg b.i.d.
Hide Arm/Group Description:
QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QVM149 150/50/80 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/320 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
QMF149 150/160 μg (indacaterol acetate/mometasone furoate) once daily (o.d.) delivered via Concept1 device
Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®
Overall Number of Participants Analyzed 615 616 611 607 612
Mean (95% Confidence Interval)
Unit of Measure: Exacerbations per year
Moderate or severe asthma exacerbation Number Analyzed 615 participants 615 participants 611 participants 607 participants 612 participants
0.46
(0.39 to 0.54)
0.58
(0.50 to 0.67)
0.54
(0.47 to 0.63)
0.67
(0.58 to 0.77)
0.72
(0.63 to 0.82)
Severe asthma exacerbation Number Analyzed 615 participants 615 participants 611 participants 607 participants 612 participants
0.26
(0.22 to 0.31)
0.38
(0.32 to 0.45)
0.33
(0.28 to 0.39)
0.41
(0.35 to 0.48)
0.45
(0.39 to 0.53)
All (mild, moderate, severe) asthma exacerbation Number Analyzed 615 participants 615 participants 611 participants 607 participants 612 participants
0.74
(0.64 to 0.85)
0.86
(0.75 to 0.98)
0.93
(0.82 to 1.06)
0.98
(0.86 to 1.11)
1.23
(1.08 to 1.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Moderate or severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments [Not Specified]
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.68 to 1.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Moderate or severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.52 to 0.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Moderate or severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.170
Comments [Not Specified]
Method Generalized linear modeñ
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.71 to 1.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Moderate or severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.66 to 0.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments Severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments [Not Specified]
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.61 to 1.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.45 to 0.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments Severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.531
Comments [Not Specified]
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.74 to 1.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments Severe asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments [Not Specified]
Method Linear generalized model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.67 to 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., QMF149 150/320 µg o.d.
Comments All (mild, moderate, severe) asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.66 to 0.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/160 µg o.d., Salmeterol/Fluticasone 50/500 μg b.i.d.
Comments All (mild, moderate, severe) asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.50 to 0.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection QVM149 150/50/80 µg o.d., QMF149 150/160 µg o.d.
Comments All (mild, moderate, severe) asthma exacerbation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.161
Comments [Not Specified]
Method Generalized linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio