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Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen

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ClinicalTrials.gov Identifier: NCT01985334
Recruitment Status : Completed
First Posted : November 15, 2013
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition COPD
Interventions Drug: Glycopyrronium
Drug: SABA
Drug: LABA
Drug: Indacaterol maleate and glycopyrronium bromide
Drug: LAMA
Drug: SAMA
Drug: ICS
Enrollment 4389
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A1 (Any SABA and/or SAMA) A2 (Glycopyrronium) B1 (Any LAMA or LABA and mMRC=1) B2 (Glycopyrronium and mMRC=1) C1 (Any LABA and ICS) C2 (Indacaterol/Glycopyrronium) D1 (Any LAMA or LABA and mMRC>1) D2 (Indacaterol/Glycopyrronium and mMRC>1)
Hide Arm/Group Description Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.) Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.) Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.) Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
Period Title: Overall Study
Started 130 387 420 1262 274 822 274 820
The Intention-to-treat (ITT) Population 122 369 420 1254 269 811 268 811
Completed 107 303 367 1033 234 666 237 699
Not Completed 23 84 53 229 40 156 37 121
Reason Not Completed
Administrative problems             1             1             0             2             0             1             1             3
Death             1             0             0             3             0             0             1             2
Worsening of disease             0             0             0             1             0             3             0             1
Other             2             9             7             17             4             8             4             7
Protocol deviation             6             31             25             84             17             47             15             42
Moderate / severe COPD exacerbation             5             14             12             40             6             40             8             19
Subject withdrawal of consent             3             6             2             28             4             19             0             20
Adverse Event             0             8             2             26             3             18             3             15
Other             4             2             3             10             1             6             2             2
Medication non-compliance             0             4             1             6             2             3             1             3
Use of prohibited treatment             1             4             1             2             1             6             2             0
Investigator decision             0             3             0             7             1             1             0             4
Lost to Follow-up             0             2             0             3             1             4             0             3
Arm/Group Title A1 (Any SABA and/or SAMA) A2 (Glycopyrronium) B1 (Any LAMA or LABA and mMRC=1) B2 (Glycopyrronium and mMRC=1) C1 (Any LABA and ICS) C2 (Indacaterol/Glycopyrronium) D1 (Any LAMA or LABA and mMRC>1) D2 (Indacaterol/Glycopyrronium and mMRC>1) Total
Hide Arm/Group Description Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.) Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.) Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.) Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.). Total of all reporting groups
Overall Number of Baseline Participants 130 387 420 1262 274 822 274 820 4389
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 387 participants 420 participants 1262 participants 274 participants 822 participants 274 participants 820 participants 4389 participants
64.2  (8.2) 63.2  (8.3) 64.6  (8.1) 64.4  (8.2) 64.4  (9.0) 64.7  (8.7) 65.1  (7.6) 65.4  (8.3) 64.6  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 387 participants 420 participants 1262 participants 274 participants 822 participants 274 participants 820 participants 4389 participants
Female
48
  36.9%
119
  30.7%
131
  31.2%
376
  29.8%
106
  38.7%
286
  34.8%
95
  34.7%
276
  33.7%
1437
  32.7%
Male
82
  63.1%
268
  69.3%
289
  68.8%
886
  70.2%
168
  61.3%
536
  65.2%
179
  65.3%
544
  66.3%
2952
  67.3%
1.Primary Outcome
Title Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)
Hide Description Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval
Time Frame Week 12 (Visit 4)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title A1 (Any SABA and/or SAMA) A2 (Glycopyrronium)
Hide Arm/Group Description:
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Overall Number of Participants Analyzed 122 369
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
1.8264
(1.7797 to 1.8732)
1.8916
(1.8647 to 1.9185)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A1 (Any SABA and/or SAMA), A2 (Glycopyrronium)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0180
Comments [Not Specified]
Method linear mixed model
Comments [Not Specified]
2.Primary Outcome
Title Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
Hide Description Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval
Time Frame Week 12 (Visit 4)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title B1 (Any LAMA or LABA and mMRC=1) B2 (Glycopyrronium and mMRC=1)
Hide Arm/Group Description:
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Overall Number of Participants Analyzed 420 1254
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
1.8004
(1.7768 to 1.8239)
1.8215
(1.8078 to 1.8352)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B1 (Any LAMA or LABA and mMRC=1), B2 (Glycopyrronium and mMRC=1)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments

H0: Glycopyrronium (50 μg o.d.) [randomized group B2] was inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.

H0: μFEV1, NVA237 – μFEV1, LABA and/or LAMA < -40 mL Ha: Glycopyrronium (50 μg o.d.) [randomized group B2] is non-inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.

Ha: μFEV1, NVA237 – μFEV1, LABA and/or LAMA ≥ -40 mL

Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method linear mixed model
Comments [Not Specified]
3.Primary Outcome
Title Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC
Hide Description Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.
Time Frame Week 12 (Visit 4)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title C1 (Any LABA and ICS) C2 (Indacaterol/Glycopyrronium)
Hide Arm/Group Description:
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
Overall Number of Participants Analyzed 269 811
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
1.6847
(1.6542 to 1.7153)
1.7558
(1.7378 to 1.7737)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C1 (Any LABA and ICS), C2 (Indacaterol/Glycopyrronium)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method linear mixed model
Comments [Not Specified]
4.Primary Outcome
Title Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
Hide Description Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.
Time Frame Week 12 (Visit 4)
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title D1 (Any LAMA or LABA and mMRC>1) D2 (Indacaterol/Glycopyrronium and mMRC>1)
Hide Arm/Group Description:
Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
Overall Number of Participants Analyzed 268 811
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
1.6728
(1.6461 to 1.6994)
1.7742
(1.7587 to 1.7896)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D1 (Any LAMA or LABA and mMRC>1), D2 (Indacaterol/Glycopyrronium and mMRC>1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method linear mixed model
Comments [Not Specified]
5.Primary Outcome
Title Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)
Hide Description Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
Time Frame Day 1 (baseline) and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title A1 (Any SABA and/or SAMA) A2 (Glycopyrronium)
Hide Arm/Group Description:
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Overall Number of Participants Analyzed 122 369
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
0.5117
(-0.0073 to 1.0306)
2.3005
(2.0015 to 2.5995)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A1 (Any SABA and/or SAMA), A2 (Glycopyrronium)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method linear mixed model
Comments [Not Specified]
6.Primary Outcome
Title Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
Hide Description Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
Time Frame Day 1 (baseline) and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title B1 (Any LAMA or LABA and mMRC=1) B2 (Glycopyrronium and mMRC=1)
Hide Arm/Group Description:
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Overall Number of Participants Analyzed 420 1254
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
0.6969
(0.4169 to 0.9769)
1.4351
(1.2718 to 1.5984)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B1 (Any LAMA or LABA and mMRC=1), B2 (Glycopyrronium and mMRC=1)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A difference of 0.6 points in TDI was adopted as boundary for non-inferiority
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method linear mixed model
Comments [Not Specified]
7.Primary Outcome
Title Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC
Hide Description Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
Time Frame Day 1 (baseline) and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title C1 (Any LABA and ICS) C2 (Indacaterol/Glycopyrronium)
Hide Arm/Group Description:
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
Overall Number of Participants Analyzed 269 811
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
0.8508
(0.4676 to 1.2340)
1.9491
(1.7207 to 2.1775)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C1 (Any LABA and ICS), C2 (Indacaterol/Glycopyrronium)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method linear mixed model
Comments [Not Specified]
8.Primary Outcome
Title Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
Hide Description Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
Time Frame Day 1 (baseline) and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title D1 (Any LAMA or LABA and mMRC>1) D2 (Indacaterol/Glycopyrronium and mMRC>1)
Hide Arm/Group Description:
Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
Overall Number of Participants Analyzed 268 811
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
0.8632
(0.5098 to 1.2166)
2.1209
(1.9130 to 2.3288)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection D1 (Any LAMA or LABA and mMRC>1), D2 (Indacaterol/Glycopyrronium and mMRC>1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method linear mixed model
Comments [Not Specified]
9.Secondary Outcome
Title Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)
Hide Description Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title A2 + B2 A1 + B1
Hide Arm/Group Description:
A2 (glycopyrronium)+B2 (glycopyrronium and mMRC=1
A1(any SABA and/or SAMA+B1 (any LAMA or LABA and mMRC=1
Overall Number of Participants Analyzed 1623 542
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
1.8373
(1.8250 to 1.8496)
1.8065
(1.7853 to 1.8276)
10.Secondary Outcome
Title Change From Baseline on on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or Long-acting Bronchodilators (LABA or LAMA Monotherapy)
Hide Description Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
Time Frame Day 1 (baseline) and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title A2 +B2 A1 +B1
Hide Arm/Group Description:
A2 (glycopyrronium)+B2 (glycopyrronium and mMRC=1
A1(any SABA and/or SAMA+B1 (any LAMA or LABA and mMRC=1)
Overall Number of Participants Analyzed 1623 542
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
1.6315
(1.4874 to 1.7756)
0.6562
(0.4085 to 0.9039)
11.Secondary Outcome
Title Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC on Trough FEV1 at Week 12.
Hide Description Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title C2 +D2 C1 + D1
Hide Arm/Group Description:
C2 (indacaterol/glycopyrronium)+D2 (indacaterol/glycopyrronium and mMRC>1)
C1 (any LABA and ICS)+D1 (any LAMA or LABA and mMRC>1)
Overall Number of Participants Analyzed 1622 537
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters
1.7650
(1.7532 to 1.7768)
1.6789
(1.6587 to 1.6992)
12.Secondary Outcome
Title Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC
Hide Description Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.
Time Frame Day 1 (baseline) and week 12
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Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title C2 +D2 C1 + D1
Hide Arm/Group Description:
C2 (indacaterol/glycopyrronium) + D2 (indacaterol/glycopyrronium and mMRC>1)
C1 (any LABA and ICS) + D1 (any LAMA or LABA and mMRC>1)
Overall Number of Participants Analyzed 1622 537
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
2.0354
(1.8811 to 2.1896)
0.8588
(0.5983 to 1.1192)
13.Secondary Outcome
Title Change From Baseline on Total Score of COPD Assessment Test (CAT) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC
Hide Description Total score of COPD Assessment Test (CAT) will be measured at baseline and at week 12. This questionnaire is completed by the patient. The score ranges from 0-40 where higher scores represent worse health status. CAT scores ≥ 10 are associated with significantly impaired health status.
Time Frame Day 1 (baseline) and Week 12
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Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title A1 (Any SABA and/or SAMA) A2 (Glycopyrronium) B1 (Any LAMA or LABA and mMRC=1) B2 (Glycopyrronium and mMRC=1) C1 (Any LABA and ICS) C2 (Indacaterol/Glycopyrronium) D1 (Any LAMA or LABA and mMRC>1) D2 (Indacaterol/Glycopyrronium and mMRC>1)
Hide Arm/Group Description:
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
Overall Number of Participants Analyzed 122 369 420 1254 269 811 268 811
Mean (Standard Deviation)
Unit of Measure: Score
0.1  (4.6) -1.8  (5.3) 0.1  (4.9) -0.5  (4.6) -0.4  (4.8) -1.4  (5.4) -0.9  (5.0) -1.9  (5.3)
14.Secondary Outcome
Title Change From Baseline on Total Score of Clinical COPD Questionnaire (CCQ) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC
Hide Description

The Clinical COPD Questionnaire (CCQ) is a self-administered 10-item questionnaire developed to measure clinical control in patients with COPD. Patients will be instructed to recall their experiences during the previous week. They respond to each question using a 7-point scale from 0 = asymptomatic/no imitation to 6 = extremely symptomatic/totally limited. The questionnaire is divided into 3 domains (symptoms [items 1, 2, 5, and 6] functional [items 7, 8, 9, and 10] and mental state [items 3 and 4]). The overall clinical COPD control score and the scores of the domains are calculated by adding all the scores together and dividing this sum by the number of questions.

Thus, the overall clinical COPD control score as well as the score on each of the three domains varies between 0 (very good control) to 6 (extremely poor control).

Time Frame Day 1 (baseline) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title A1 (Any SABA and/or SAMA) A2 (Glycopyrronium) B1 (Any LAMA or LABA and mMRC=1) B2 (Glycopyrronium and mMRC=1) C1 (Any LABA and ICS) C2 (Indacaterol/Glycopyrronium) D1 (Any LAMA or LABA and mMRC>1) D2 (Indacaterol/Glycopyrronium and mMRC>1)
Hide Arm/Group Description:
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
Overall Number of Participants Analyzed 122 369 420 1254 269 811 268 811
Mean (Standard Deviation)
Unit of Measure: Score
-0.0  (0.6) -0.3  (0.7) 0.0  (0.7) -0.1  (0.7) -0.1  (0.7) -0.2  (0.8) -0.1  (0.8) -0.3  (0.8)
15.Secondary Outcome
Title Mean Number of Puffs of Rescue Medication Use for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC
Hide Description Mean number of puffs of rescue medication use will be measured using eDiary data over 12 weeks of treatment.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title A1 (Any SABA and/or SAMA) A2 (Glycopyrronium) B1 (Any LAMA or LABA and mMRC=1) B2 (Glycopyrronium and mMRC=1) C1 (Any LABA and ICS) C2 (Indacaterol/Glycopyrronium) D1 (Any LAMA or LABA and mMRC>1) D2 (Indacaterol/Glycopyrronium and mMRC>1)
Hide Arm/Group Description:
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
Overall Number of Participants Analyzed 122 369 420 1254 269 811 268 811
Mean (Standard Deviation)
Unit of Measure: Number of puffs
1.8  (1.7) 1.0  (1.3) 0.8  (1.2) 0.7  (1.1) 1.6  (1.7) 1.1  (1.4) 1.4  (1.4) 1.1  (1.3)
16.Secondary Outcome
Title Mean Change From Baseline Reported Symptoms of COPD for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC
Hide Description Patient-reported symptoms of COPD combined will be measured using eDiary data reported over the 12 week treatment period. The mean total symptom scores and mean individual symptom scores for the patient were calculated for the whole study period. The mean change from baseline in the total scores and in the individual scores were summarized by treatment and were analyzed for the percentage of nights with no nighttime awakenings and percentage of days with no symptoms.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups
Arm/Group Title A1 (Any SABA and/or SAMA) A2 (Glycopyrronium) B1 (Any LAMA or LABA and mMRC=1) B2 (Glycopyrronium and mMRC=1) C1 (Any LABA and ICS) C2 (Indacaterol/Glycopyrronium) D1 (Any LAMA or LABA and mMRC>1) D2 (Indacaterol/Glycopyrronium and mMRC>1)
Hide Arm/Group Description:
Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA
Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA
Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC
Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)
Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA
Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
Overall Number of Participants Analyzed 122 369 420 1254 269 811 268 811
Mean (Standard Deviation)
Unit of Measure: Percentage of days
-0.04  (0.15) -0.10  (0.22) -0.03  (0.19) -0.05  (0.20) -0.05  (0.19) -0.07  (0.22) -0.04  (0.19) -0.09  (0.21)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A1 (Any SABA and/or SAMA) A2 (Glycopyrronium) B1 (Any LAMA or@ LABA and mMRC eq 1) B2 (Glycopyrronium@ and mMRC eq 1) C1 (Any LABA and ICS) C2 (Indacaterol/@Glycopyrronium) D1 (Any LAMA or@ LABA and mMRC gt 1) D2 (Indacaterol/@Glycopyrronium and@ mMRC gt 1)
Hide Arm/Group Description Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination at enrollment and randomized to remain in their baseline therapy with any SABA and/or SAMA Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.) Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.) Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.) Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).
All-Cause Mortality
A1 (Any SABA and/or SAMA) A2 (Glycopyrronium) B1 (Any LAMA or@ LABA and mMRC eq 1) B2 (Glycopyrronium@ and mMRC eq 1) C1 (Any LABA and ICS) C2 (Indacaterol/@Glycopyrronium) D1 (Any LAMA or@ LABA and mMRC gt 1) D2 (Indacaterol/@Glycopyrronium and@ mMRC gt 1)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A1 (Any SABA and/or SAMA) A2 (Glycopyrronium) B1 (Any LAMA or@ LABA and mMRC eq 1) B2 (Glycopyrronium@ and mMRC eq 1) C1 (Any LABA and ICS) C2 (Indacaterol/@Glycopyrronium) D1 (Any LAMA or@ LABA and mMRC gt 1) D2 (Indacaterol/@Glycopyrronium and@ mMRC gt 1)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/125 (3.20%)   9/385 (2.34%)   11/417 (2.64%)   30/1248 (2.40%)   6/269 (2.23%)   22/816 (2.70%)   10/269 (3.72%)   34/814 (4.18%) 
Blood and lymphatic system disorders                 
Anaemia  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Immune thrombocytopenic purpura  1  0/125 (0.00%)  1/385 (0.26%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Cardiac disorders                 
Acute coronary syndrome  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Acute myocardial infarction  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  2/1248 (0.16%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Angina pectoris  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Angina unstable  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  1/269 (0.37%)  0/814 (0.00%) 
Aortic valve incompetence  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Aortic valve stenosis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Arrhythmia  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Arteriosclerosis coronary artery  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  1/269 (0.37%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Atrial fibrillation  1  0/125 (0.00%)  1/385 (0.26%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Cardiac arrest  1  1/125 (0.80%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Cardiac failure  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Coronary artery disease  1  0/125 (0.00%)  2/385 (0.52%)  1/417 (0.24%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Ischaemic cardiomyopathy  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Left ventricular failure  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Myocardial infarction  1  1/125 (0.80%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  1/269 (0.37%)  1/814 (0.12%) 
Myocardial ischaemia  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  1/269 (0.37%)  0/814 (0.00%) 
Supraventricular tachycardia  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Tachycardia  1  0/125 (0.00%)  1/385 (0.26%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Congenital, familial and genetic disorders                 
Congenital central nervous system anomaly  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Hydrocele  1  1/125 (0.80%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Ear and labyrinth disorders                 
Vertigo  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  2/816 (0.25%)  0/269 (0.00%)  0/814 (0.00%) 
Gastrointestinal disorders                 
Abdominal hernia  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Abdominal incarcerated hernia  1  0/125 (0.00%)  1/385 (0.26%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Constipation  1  0/125 (0.00%)  0/385 (0.00%)  1/417 (0.24%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Diverticulum oesophageal  1  0/125 (0.00%)  1/385 (0.26%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Faecaloma  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Gastrointestinal haemorrhage  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Inguinal hernia  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Pancreatitis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
General disorders                 
Chest pain  1  0/125 (0.00%)  1/385 (0.26%)  0/417 (0.00%)  2/1248 (0.16%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Fatigue  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Hernia  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Sudden death  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Ulcer  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Hepatobiliary disorders                 
Bile duct stone  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Biliary tract disorder  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Hepatic cirrhosis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Immune system disorders                 
Anaphylactic shock  1  0/125 (0.00%)  0/385 (0.00%)  1/417 (0.24%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Drug hypersensitivity  1  0/125 (0.00%)  1/385 (0.26%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Infections and infestations                 
Bronchitis  1  0/125 (0.00%)  0/385 (0.00%)  1/417 (0.24%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Cystitis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  1/269 (0.37%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Diverticulitis  1  0/125 (0.00%)  0/385 (0.00%)  1/417 (0.24%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Influenza  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Mediastinal abscess  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Oesophageal candidiasis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Pneumonia  1  0/125 (0.00%)  1/385 (0.26%)  0/417 (0.00%)  2/1248 (0.16%)  0/269 (0.00%)  1/816 (0.12%)  1/269 (0.37%)  7/814 (0.86%) 
Injury, poisoning and procedural complications                 
Ankle fracture  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Bursa injury  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Facial bones fracture  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Femoral neck fracture  1  0/125 (0.00%)  0/385 (0.00%)  1/417 (0.24%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Femur fracture  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Fracture  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  1/269 (0.37%)  0/814 (0.00%) 
Hip fracture  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Jaw fracture  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  1/269 (0.37%)  0/814 (0.00%) 
Ligament rupture  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Rib fracture  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  1/269 (0.37%)  1/814 (0.12%) 
Splenic rupture  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Traumatic intracranial haemorrhage  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  1/269 (0.37%)  0/814 (0.00%) 
Wound dehiscence  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Investigations                 
Blood pressure increased  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Heart rate decreased  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Metabolism and nutrition disorders                 
Dehydration  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  1/269 (0.37%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Back pain  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Osteoarthritis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Pseudarthrosis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Synovitis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Bladder neoplasm  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Brain neoplasm  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Breast cancer  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  2/814 (0.25%) 
Bronchial carcinoma  1  0/125 (0.00%)  1/385 (0.26%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Colon cancer  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Laryngeal cancer  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Lung adenocarcinoma  1  1/125 (0.80%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Metastases to bone  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Oropharyngeal cancer  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Prostate cancer  1  0/125 (0.00%)  0/385 (0.00%)  1/417 (0.24%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Squamous cell carcinoma of the tongue  1  0/125 (0.00%)  0/385 (0.00%)  1/417 (0.24%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Nervous system disorders                 
Cerebral ischaemia  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Cerebrovascular accident  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  1/816 (0.12%)  1/269 (0.37%)  0/814 (0.00%) 
Cerebrovascular disorder  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Cerebrovascular insufficiency  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Embolic cerebral infarction  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Loss of consciousness  1  0/125 (0.00%)  0/385 (0.00%)  1/417 (0.24%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Ruptured cerebral aneurysm  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  1/269 (0.37%)  0/814 (0.00%) 
Syncope  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Transient ischaemic attack  1  1/125 (0.80%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Vascular dementia  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  1/269 (0.37%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Vascular encephalopathy  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  1/269 (0.37%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Psychiatric disorders                 
Alcoholism  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Depression  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  1/269 (0.37%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Renal and urinary disorders                 
Nephrolithiasis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Chronic obstructive pulmonary disease  1  0/125 (0.00%)  1/385 (0.26%)  1/417 (0.24%)  3/1248 (0.24%)  1/269 (0.37%)  3/816 (0.37%)  1/269 (0.37%)  3/814 (0.37%) 
Pneumothorax  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Pulmonary embolism  1  0/125 (0.00%)  0/385 (0.00%)  1/417 (0.24%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  1/269 (0.37%)  1/814 (0.12%) 
Pulmonary haemorrhage  1  1/125 (0.80%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Pulmonary oedema  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Respiratory depression  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Skin and subcutaneous tissue disorders                 
Blister  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  0/814 (0.00%) 
Vascular disorders                 
Aortic aneurysm  1  0/125 (0.00%)  1/385 (0.26%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Aortic stenosis  1  0/125 (0.00%)  1/385 (0.26%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Circulatory collapse  1  0/125 (0.00%)  0/385 (0.00%)  1/417 (0.24%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Deep vein thrombosis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  2/814 (0.25%) 
Femoral artery aneurysm  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Hypertension  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  1/816 (0.12%)  1/269 (0.37%)  1/814 (0.12%) 
Hypertensive crisis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Intermittent claudication  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  1/269 (0.37%)  0/814 (0.00%) 
Ischaemia  1  0/125 (0.00%)  1/385 (0.26%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Peripheral arterial occlusive disease  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  3/814 (0.37%) 
Peripheral artery aneurysm  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Peripheral artery stenosis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  3/814 (0.37%) 
Peripheral artery thrombosis  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  1/269 (0.37%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Shock  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  0/814 (0.00%) 
Thrombophlebitis superficial  1  0/125 (0.00%)  0/385 (0.00%)  0/417 (0.00%)  0/1248 (0.00%)  0/269 (0.00%)  0/816 (0.00%)  0/269 (0.00%)  1/814 (0.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
A1 (Any SABA and/or SAMA) A2 (Glycopyrronium) B1 (Any LAMA or@ LABA and mMRC eq 1) B2 (Glycopyrronium@ and mMRC eq 1) C1 (Any LABA and ICS) C2 (Indacaterol/@Glycopyrronium) D1 (Any LAMA or@ LABA and mMRC gt 1) D2 (Indacaterol/@Glycopyrronium and@ mMRC gt 1)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/125 (15.20%)   67/385 (17.40%)   63/417 (15.11%)   163/1248 (13.06%)   29/269 (10.78%)   119/816 (14.58%)   20/269 (7.43%)   120/814 (14.74%) 
Gastrointestinal disorders                 
Dyspepsia  1  2/125 (1.60%)  0/385 (0.00%)  1/417 (0.24%)  3/1248 (0.24%)  0/269 (0.00%)  2/816 (0.25%)  0/269 (0.00%)  1/814 (0.12%) 
Infections and infestations                 
Bronchitis  1  0/125 (0.00%)  4/385 (1.04%)  4/417 (0.96%)  4/1248 (0.32%)  1/269 (0.37%)  1/816 (0.12%)  1/269 (0.37%)  3/814 (0.37%) 
Nasopharyngitis  1  8/125 (6.40%)  38/385 (9.87%)  24/417 (5.76%)  71/1248 (5.69%)  11/269 (4.09%)  37/816 (4.53%)  10/269 (3.72%)  54/814 (6.63%) 
Pharyngitis  1  3/125 (2.40%)  1/385 (0.26%)  0/417 (0.00%)  7/1248 (0.56%)  0/269 (0.00%)  3/816 (0.37%)  1/269 (0.37%)  5/814 (0.61%) 
Rhinitis  1  0/125 (0.00%)  1/385 (0.26%)  7/417 (1.68%)  12/1248 (0.96%)  2/269 (0.74%)  5/816 (0.61%)  1/269 (0.37%)  10/814 (1.23%) 
Tracheitis  1  2/125 (1.60%)  0/385 (0.00%)  2/417 (0.48%)  2/1248 (0.16%)  0/269 (0.00%)  2/816 (0.25%)  0/269 (0.00%)  2/814 (0.25%) 
Urinary tract infection  1  2/125 (1.60%)  2/385 (0.52%)  1/417 (0.24%)  5/1248 (0.40%)  0/269 (0.00%)  1/816 (0.12%)  0/269 (0.00%)  3/814 (0.37%) 
Musculoskeletal and connective tissue disorders                 
Back pain  1  2/125 (1.60%)  6/385 (1.56%)  3/417 (0.72%)  8/1248 (0.64%)  2/269 (0.74%)  10/816 (1.23%)  2/269 (0.74%)  11/814 (1.35%) 
Nervous system disorders                 
Headache  1  0/125 (0.00%)  7/385 (1.82%)  3/417 (0.72%)  9/1248 (0.72%)  1/269 (0.37%)  12/816 (1.47%)  1/269 (0.37%)  8/814 (0.98%) 
Respiratory, thoracic and mediastinal disorders                 
Cough  1  3/125 (2.40%)  5/385 (1.30%)  13/417 (3.12%)  33/1248 (2.64%)  5/269 (1.86%)  44/816 (5.39%)  4/269 (1.49%)  27/814 (3.32%) 
Dyspnoea  1  1/125 (0.80%)  5/385 (1.30%)  6/417 (1.44%)  13/1248 (1.04%)  6/269 (2.23%)  7/816 (0.86%)  2/269 (0.74%)  7/814 (0.86%) 
Oropharyngeal pain  1  0/125 (0.00%)  4/385 (1.04%)  3/417 (0.72%)  10/1248 (0.80%)  4/269 (1.49%)  3/816 (0.37%)  1/269 (0.37%)  4/814 (0.49%) 
Productive cough  1  0/125 (0.00%)  4/385 (1.04%)  0/417 (0.00%)  1/1248 (0.08%)  0/269 (0.00%)  2/816 (0.25%)  2/269 (0.74%)  0/814 (0.00%) 
Vascular disorders                 
Hypertension  1  1/125 (0.80%)  3/385 (0.78%)  7/417 (1.68%)  7/1248 (0.56%)  2/269 (0.74%)  5/816 (0.61%)  0/269 (0.00%)  7/814 (0.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01985334     History of Changes
Other Study ID Numbers: CQVA149A3401
First Submitted: November 4, 2013
First Posted: November 15, 2013
Results First Submitted: April 5, 2017
Results First Posted: March 19, 2019
Last Update Posted: March 19, 2019