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Trial record 59 of 318 for:    FLUTICASONE AND SALMETEROL

Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01636076
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : November 17, 2014
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition COPD
Interventions Drug: QMF149
Drug: Salmeterol
Enrollment 629
Recruitment Details  
Pre-assignment Details  
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Period Title: Overall Study
Started 316 313
Completed 299 288
Not Completed 17 25
Reason Not Completed
Terminated by sponsor             1             1
Lack of Efficacy             0             1
Lost to Follow-up             1             0
Physician Decision             1             1
Non-compliance with study treatment             1             1
Adverse Event             6             11
Withdrawal by Subject             7             10
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate Total
Hide Arm/Group Description QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler® Total of all reporting groups
Overall Number of Baseline Participants 316 313 629
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 316 participants 313 participants 629 participants
64.8  (7.74) 64.1  (7.89) 64.5  (7.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 313 participants 629 participants
Female
83
  26.3%
86
  27.5%
169
  26.9%
Male
233
  73.7%
227
  72.5%
460
  73.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 316 participants 313 participants 629 participants
American Indian or Alaska Native 0 0 0
Asian 32 30 62
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 1 1 2
White 273 276 549
Other 9 6 15
Unknown or Not Reported 1 0 1
1.Primary Outcome
Title Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85
Hide Description Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients were included in the Full analysis set (FAS)
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Full analysis set (n=291,282) 1.270  (0.0124) 1.215  (0.0124)
Per protocol set (n=259,251) 1.277  (0.0136) 1.228  (0.0137)
2.Secondary Outcome
Title Trough FEV1 After First Dose and After 4 Weeks of Treatment
Hide Description Spirometry is conducted according to the global standard. FEV1 is measured at pre-dose and post dose up to 1 hours on Day 1 and Day 28; 24 hours post-dose on Day 29 and 85. In a subset of approximately 60 patients, FEV1 is measured up to 20 hours postdose on Day 28 and Day 84.
Time Frame Day 1 and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients were included in the Safety analysis set (SAF) and Full analysis set (FAS).
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Mean (Standard Error)
Unit of Measure: Liters
Baseline Day 2 (n=286, 302) 1.147  (0.0237) 1.167  (0.0264)
Day 2 (n=286, 302) 1.216  (0.0106) 1.243  (0.0104)
Baseline Day 29 (n=293, 296) 1.148  (0.0236) 1.178  (0.0266)
Day 29 (n=293,296) 1.277  (0.0119) 1.247  (0.0119)
Day 84 baseline (n=289,287) 1.144  (0.0240) 1.187  (0.0267)
Day 84 (n=289,287) 1.269  (0.0139) 1.208  (0.0139)
3.Secondary Outcome
Title Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Hide Description [Not Specified]
Time Frame Day 1 through day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Least Squares Mean (Standard Error)
Unit of Measure: liter
Absolute Value Day 1/5min (n=290,298) 1.254  (0.0069) 1.198  (0.0068)
Absolute Value Day 1/30 min (n=294,306) 1.281  (0.0079) 1.250  (0.0087)
Absolute Value Day 1/60min (n=300,303) 1.281  (0.0087) 1.256  (0.0087)
Absolute Value Day 2/ 23 hr 10 min (n=288,295) 1.213  (0.0108) 1.239  (0.0107)
Absolute Value Day 2/ 23 hr 45 min (n=297,305) 1.215  (0.0106) 1.244  (0.0105)
Absolute Value Day 28/ -50min (n=288,295) 1.265  (0.0132) 1.287  (0.0139)
Absolute Value Day 28/ -15min (n=292,290) 1.287  (0.0132) 1.235  (0.0140)
Absolute Value Day 28/ 5min (n=290,289) 1.329  (0.0113) 1.268  (0.0113)
Absolute Value Day 28/ 30min (n=293,290) 1.352  (0.0118) 1.298  (0.0118)
Absolute Value Day 28/ 60min (n=292,290) 1.353  (0.0123) 1.298  (0.0122)
Absolute Value Day 29/ 23 hr 10 min (n=285,292) 1.269  (0.0118) 1.242  (0.0117)
Absolute Value Day 29/ 23 hr 45 min (n=290,295) 1.281  (0.0123) 1.254  (0.0122)
Absolute Value Day 84/ -50 min (n=286,278) 1.259  (0.0140) 1.195  (0.0141)
Absolute Value Day 84/ -15 min (n=282,285) 1.282  (0.0146) 1.222  (0.0147)
Absolute Value Day 84/ 5 min (n=280,279) 1.336  (0.0128) 1.243  (0.0128)
Absolute Value Day 84/ 30 min (n=286,280) 1.352  (0.0124) 1.277  (0.0124)
Absolute Value Day 84/ 60 min (n=287,281) 1.351  (0.0128) 1.283  (0.0128)
Absolute Value Day 84/ 23 hr 10 min (n=292,291) 1.264  (0.0125) 1.212  (0.0125)
Absolute Value Day 84/ 23 hr 45 min (n=291,285) 1.273  (0.0125) 1.221  (0.0126)
4.Secondary Outcome
Title Forced Vital Capacity (FVC) at Each Timepoint
Hide Description Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.
Time Frame Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Mean (Standard Deviation)
Unit of Measure: liters
Baseline (n=316,313) 2.460  (0.6969) 2.481  (0.7209)
Day 1/ 5 min (n=299,298) Change 0.179  (0.2165) 0.060  (0.1404)
Day 1/ 30 min (n=302,306) Change 0.207  (0.2279) 0.129  (0.1953)
Day 1/ 60 min (n=308,303) Change 0.222  (0.2472) 0.152  (0.2287)
Day 1/ 4 hr (n=302,297) Change 0.217  (0.2847) 0.183  (0.2611)
Day 2/ 23hr 10 min (n=297,296) Change 0.089  (0.2518) 0.092  (0.2896)
Day 2/ 23hr 45 min (n=307,306) Change 0.083  (0.2583) 0.092  (0.2815)
Day 28 / -50 min (n=295,296) Change 0.132  (0.2806) 0.068  (0.2814)
Day 28 / -15 min (n=300,291) Change 0.161  (0.3090) 0.072  (0.2892)
Day 28 / 5 min (n=297,290) Change 0.238  (0.3163) 0.122  (0.3068)
Day 28 / 30 min (n=301,291) Change 0.263  (0.3169) 0.168  (0.3166)
Day 28 / 60 min (n=299,292) Change 0.279  (0.3261) 0.189  (0.3350)
Day 29 / 23hr 10 min (n=293,293) Change 0.121  (0.2955) 0.084  (0.2817)
Day 29 /23hr 45 min (n=299,296) Change 0.133  (0.3132) 0.097  (0.2965)
Day 84 / -50min (n=295,279) Change 0.125  (0.2979) 0.144  (0.3570)
Day 84 /-15 min (n=291,286) Change 0.144  (0.3234) 0.049  (0.3519)
Day 84 / 5 min (n=288,290) Change 0.229  (0.3370) 0.076  (0.3729)
Day 84 /30 min (n=295,281) Change 0.255  (0.3344) 0.120  (0.3537)
Day 84 / 60 min (n=296,282) Change 0.272  (0.3295) 0.159  (0.3648)
Day 85 / 23 hr 10 min (n=302,292) Change 0.113  (0.3132) 0.022  (0.3482)
Day 85 / 23 hr 45 min (n=301,286) Change 0.126  (0.3206) 0.035  (0.3620)
5.Secondary Outcome
Title FEV1/FVC at Each Timepoint
Hide Description Spirometry is conducted according to the global standard. FEV1/FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.
Time Frame Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Mean (Standard Deviation)
Unit of Measure: FEV1/ FVC (%)
Baseline (n=316, 313) 46.786  (10.0306) 46.859  (10.0392)
Day 1 / 5 min (n=299, 298) change 0.488  (2.9633) 0.047  (2.1366)
Day 1 / 30 min (n=302,306) change 0.955  (3.0166) 0.879  (2.7281)
Day 1 / 60 min (n=308,303) change 1.112  (3.1413) 1.182  (3.0612)
Day 1 / 4 hr (n=302, 297) change 1.045  (3.3917) 1.397  (3.2407)
Day 2 / 23 Hr 10 min (n=297,296) change 0.503  (3.3450) 1.042  (3.2074)
Day 2 / 23 Hr 45 min (n=307,306) change 0.583  (3.4552) 1.319  (3.1977)
Day 28 / -50 min (n=295,296) change 1.463  (3.7864) 1.140  (3.8900)
Day 28 / -15 min (n=300,291) change 1.837  (3.9769) 1.495  (3.7597)
Day 28 / 5 min (n=297,290) change 1.951  (4.0512) 1.581  (4.006)
Day 28 / 30 min (n=301,291) change 2.296  (4.4904) 1.873  (4.2723)
Day 28 / 60 min (n=299,292) change 2.525  (4.3228) 2.060  (4.4398)
Day 28 / 4 hr (n=44,45) change 4.034  (5.2622) 2.322  (4.0257)
Day 28 / 11hr 10 min (n=47,44) change 2.553  (4.0260) 1.909  (3.9389)
Day 28 / 11hr 45 min (n=43,42) change 2.791  (4.1708) 2.476  (4.3978)
Day 28 / 16 hr (n=40,41) change 2.250  (3.4006) 2.305  (4.3111)
Day 28 / 20 hr (n=43,44) change 2.535  (3.5379) 2.250  (3.9935)
Day 29 / 23 hr 10 min (n=293,293) change 1.771  (4.0730) 1.319  (3.8200)
Day 29 / 23 hr 45 min (n=299,296) change 2.000  (4.0562) 1.566  (3.9704)
Day 84 / -50 min (n=295,279) change 1.449  (4.1145) 1.068  (4.1776)
Day 84 / -15 min (n=291,286) change 2.155  (4.0673) 1.584  (4.3278)
Day 84 / 5 min (n=288,280) change 2.332  (4.1032) 1.796  (4.2310)
Day 84 / 30 min (n=295,281) change 2.420  (4.3561) 2.062  (4.3941)
Day 84 / 60 min (n=296,282) change 2.571  (4.4128) 2.067  (4.3512)
Day 84 / 4 hr (n=45,44) change 2.389  (3.7079) 2.682  (4.3269)
Day 84 / 11hr 10 min (n=45,43) change 1.944  (4.0833) 2.105  (3.8754)
Day 84 / 11 hr 45 min (n=39,39) change 2.538  (3.7895) 2.295  (4.1147)
Day 84 / 16 hr (n=41,39) change 1.415  (4.0588) 1.962  (3.6981)
Day 84 / 20 hr (n=44,43) change 2.364  (4.4315) 1.837  (3.7713)
Day 84 / 23 hr 10 min (n=302,292) change 1.856  (4.4315) 1.414  (4.0356)
Day 84 / 23 hr 45 min (n=301,286) change 2.098  (4.3676) 1.593  (4.2110)
6.Secondary Outcome
Title FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min – 4h)
Hide Description Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), Scheduled (not actual) time points are to be used. The standardized AUC(5 min – 4 h) for FEV1 will be summarized by treatment.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Least Squares Mean (Standard Error)
Unit of Measure: Liters * hours
Day 1 baseline (n=303,311) 1.142  (0.0233) 1.169  (0.0259)
Day 1 post (n=303,311) 1.277  (0.0086) 1.260  (0.0085)
7.Secondary Outcome
Title FEV1 AUC (5 Min-4 h),
Hide Description Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min – 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.
Time Frame Day 1(Baseline), Day 28, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
24 hr profiling subgroup
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: Liters*hours
Day 1 baseline (n=46,47) 1.302  (0.0278) 1.331  (0.0282)
Day 28 (n=45,46) 1.410  (0.0353) 1.355  (0.0355)
Day 84 (n=44,46) 1.387  (0.0401) 1.372  (0.0401)
8.Secondary Outcome
Title Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for AUC (5 Min – 23 h 45 Min) for FEV1 (L) on Day 28 and Day 84 (Full Analysis Set, 24-h Profiling Subgroup)
Hide Description Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min – 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.
Time Frame Day 28, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Peak FEV1 was calculated for all subjects in the FAS at Day 1 (Visit 201) and was calculated for all subjects in the 24-h profiling subset of the FAS at Day 1 (Visit 201), Day 28 (Visit 203) and Day 84 (Visit 205).
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: Liters*hours
Day 28 (n=45,46) 1.352  (0.0428) 1.298  (0.0431)
Day 85 (n=47,47) 1.317  (0.0454) 1.303  (0.0459)
9.Secondary Outcome
Title The Usage of Rescue Medication (Short Acting β2-agonist)
Hide Description Participants record the number of puffs of rescue medication taken in the previous 12 hours each morning and evening throughout the 12 week treatment period.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Least Squares Mean (Standard Error)
Unit of Measure: Number of puffs
Daily Change Weeks 1-12 (n-281,274) -1.064  (0.1615) -0.593  (0.1621)
Daytime Change Weeks 1-12 (n=276-272) -0.625  (0.1021) -0.300  (0.1026)
Nighttime Change Weeks 1-12 (n=281,271) -0.452  (0.0748) -0.308  (0.0751)
10.Secondary Outcome
Title The Overall Change in Usage of Rescue Medication (Short Acting β2-agonist) .
Hide Description This value represents the percent of days in the study where no rescue medication was needed.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Least Squares Mean (Standard Error)
Unit of Measure: % of days
8.796  (2.3845) 2.538  (2.3980)
11.Secondary Outcome
Title Patient Reported Outcome Measures: SGRQ (St. George’s Respiratory Questionnaire)
Hide Description A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.
Time Frame 4 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set : At baseline all subjects with a baseline value are included. At each post-baseline day, only subjects with a value at both baseline and the respective day are included. Baseline SGRQ was completed on Day 1 prior to first dose.
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Mean (Standard Deviation)
Unit of Measure: Total Score
Baseline (n=314, 308) 43.05  (18.515) 42.28  (17.941)
Day 28 Baseline (n=304,295) 42.87  (18.392) 42.47  (18.051)
Day 28 Post (n=304,295) 40.95  (18.527) 42.18  (18.101)
Day 28 Change (n=304,295) -1.92  (11.383) -0.29  (12.145)
Day 84 Baseline (n=297,284) 42.57  (18.322) 42.03  (18.099)
Day 84 Post (n=297,284) 39.81  (19.057) 41.01  (18.553)
Day 84 Change (n=297,284) -2.76  (13.062) -1.02  (12.178)
12.Secondary Outcome
Title Analysis of the Proportion of Subjects With a Clinically Important Improvement of >=1 Point in the TDI (Transitional Dyspnoea Index)Focal Score by Visit
Hide Description A TDI focal score of ≥1 is considered to be a clinically important improvement from baseline. Analysis of the proportion of subjects with a clinically important improvement of >=1 point in the TDI focal score, by visit
Time Frame 4 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, All randomized patients. When data were missing or insufficient for any one of the domains a focal score could not be calculated.
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Measure Type: Number
Unit of Measure: (%) showing clinical improvement
Day 28 Change from baseline (n=291,294) 43.3 40.5
Day 84 Change from baseline (n=287,283) 52.6 45.9
13.Secondary Outcome
Title Patient Reported Outcome Measures: COPD Assessment Test
Hide Description It consists of eight items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.
Time Frame Baseline, 4 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n= 311,308) 16.3  (7.60) 16.2  (7.48)
Day 28 baseline (n=303,298) 16.2  (7.58) 16.2  (7.48)
Day 28 Post (n=303,298) 15.8  (7.63) 16.8  (7.75)
Day 28 Change (n=303,298) -0.4  (5.56) 0.6  (4.94)
Day 84 Baseline (n=295,285) 15.9  (7.54) 16.1  (8.38)
Day 84 Post (n=295,285) 15.5  (7.56) 16.3  (8.38)
Day 84 change (n=295,285) -0.4  (5.77) 0.2  (5.84)
14.Secondary Outcome
Title Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Hide Description

Scoring the MOS Sleep Survey is a two-step process:• All items are scored so that a high score reflects more of the attribute implied by the scale name. Each item is converted to a 0 to 100 possible range so that the lowest and highest possible scores are set at 0 and 100, respectively. In this format, scores represent the achieved percentage of the total possible score. For example, a score of 50 represents 50% of the highest possible score.

• Second, items within each scale are averaged together to create the 7 scale scores. Scales with at least one item answered can be used to generate a scale score. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Scores represent the average for all items in the scale that the respondent answered. An additional measure is based on the average number of hours sleep each night during the past 4 weeks and are described in outcome measure 15.

Time Frame Baseline, 4 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set.
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 302 296
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Sleep disturbance Day 28 Baseline (n=290,285) 49.6833  (8.57069) 49.7616  (8.49307)
Sleep disturbance Baseline (n=299,295) 49.6423  (8.50059) 49.9292  (8.51330)
Sleep disturbance Day 28 post (n=290,285) 50.9323  (8.92540) 50.0858  (8.77110)
Sleep disturbance Day 28 change (n=290,285) 1.2490  (5.67591) 0.3242  (6.63156)
Sleep disturbance Day 84 Baseline (n=283,274) 49.7622  (8.61100) 49.6634  (8.41228)
Sleep disturbance Day 84 Post (n=283,274) 50.7508  (9.22016) 50.2380  (9.07204)
Sleep disturbance Day 84 Change (n=283,274) 0.9887  (6.52972) 0.5745  (6.45362)
Sleep snoring Baseline (n=299,295) 48.8815  (9.32313) 49.8895  (9.18885)
Sleep snoring Day 28 Baseline (n=290,285) 48.8234  (9.40239) 49.7733  (9.23030)
Sleep snoring Day 28 Post (n=290,285) 49.3476  (9.37744) 49.5067  (9.39012)
Sleep snoring Day 28 change(n=290,285) 0.5241  (6.70023) -0.2667  (7.06825)
Sleep snoring Day 84 Baseline (n=283,274) 48.8414  (9.29113) 49.6385  (9.19681)
Sleep snoring Day 84 post (n=283,274) 49.4591  (9.29113) 49.6108  (9.51632)
Sleep snoring Day 84 change (n=283,274) 0.6177  (7.42456) -0.0277  (8.266668)
Sleep shortness of breath Baseline (n=302,295) 44.5221  (13.28329) 45.4259  (11.51560)
Sleep shortness of breath D 28 Bseline(n=293,285) 44.6348  (13.15710) 45.3292  (11.48556)
Sleep shortness of breath D 28 post (n=293,285) 45.8814  (11.85664) 45.5774  (11.65379)
Sleep shortness of breath D 28 change (n=293,285) 1.2466  (12.21272) 0.2481  (11.44262)
Sleep shortness of breath D 84 Bseline (n=287,274) 44.8645  (12.99605) 45.3180  (11.37006)
Sleep shortness of breath D 84 post (n=287,274) 45.7676  (13.20151) 45.7049  (11.84910)
Sleep shortness of breath D 84 change (n=287,274) 0.9031  (12.11351) 0.3870  (10.97093)
Sleep adequacy baseline (n=300,295) 54.9999  (9.85865) 54.9725  (9.41704)
Sleep adequacy baseline D 28 (n=291,285) 55.0531  (9.80609) 55.0679  (9.30955)
Sleep adequacy Post D 28 (n=291,285) 55.2032  (10.04281) 54.8296  (10.21011)
Sleep adequacy Change D 28 (n=291,285) 0.1501  (9.83920) -0.2383  (9.21250)
Sleep adequacy baseline D 84 (n=284,274) 55.2125  (9.81055) 55.1084  (9.20723)
Sleep adequacy Post D 84 (n=284,274) 55.2467  (10.00283) 54.5424  (9.96705)
Sleep adequacy change D 84 (n=284,274) 0.0342  (8.81793) -0.5659  (8.57800)
Sleep somnolence baseline (n=302,296) 47.6646  (9.56376) 49.1709  (9.56807)
Sleep somnolence baseline D28 (n=290,285) 47.8711  (9.48940) 49.1092  (9.58808)
Sleep somnolence post D28 (n=290,285) 48.4429  (9.93046) 48.6761  (10.17850)
Sleep somnolence change D28 (n=290,285) 0.5718  (7.91162) -0.4331  (8.67719)
Sleep somnolence baseline D84 (n=284,274) 47.7821  (9.53639) 48.9335  (9.55603)
Sleep somnolence post D84 (n=284,274) 48.2568  (10.36223) 49.0461  (9.54132)
Sleep somnolence change D84 (n=284,274) 0.4747  (8.11292) 0.1126  (7.83662)
Sleep Problems Index 1 Baseline (n=300,295) 50.4795  (9.72203) 50.8382  (9.16082)
Sleep Problems Index 1 Baseline D28 (n=290,285) 50.6034  (9.67464) 50.7911  (9.13425)
Sleep Problems Index 1 Post D28 (n=290,285) 51.4799  (9.86137) 50.7836  (10.02742)
Sleep Problems Index 1 Change D28 (n=290,285) 0.8764  (7.03960) -0.0074  (7.73909)
Sleep Problems Index 1 Baseline D84 (n=284,274) 50.7327  (9.64776) 50.6951  (9.09626)
Sleep Problems Index 1 Post D84 (n=284,274) 51.3590  (10.16584) 50.9888  (9.54642)
Sleep Problems Index 1 Change D84 (n=284,274) 0.6263  (7.22742) 0.2938  (7.08082)
Sleep Problems Index 2 baseline (n=299,295) 50.4610  (9.14154) 51.0701  (8.62899)
Sleep Problems Index 2 baseline D 28 (n=289,285) 50.5720  (9.15508) 50.9923  (8.60656)
Sleep Problems Index 2 Post D 28 (n=289,285) 51.5578  (9.43365) 51.0116  (9.33837)
Sleep Problems Index 2 Change D 28 (n=289,285) 0.9858  (6.00711) 0.0193  (6.99119)
Sleep Problems Index 2 Baseline D 84 (n=283,274) 50.6880  (9.16092) 50.8848  (8.58893)
Sleep Problems Index 2 Post D 84 (n=283,274) 51.4615  (9.79518) 51.1511  (9.09673)
Sleep Problems Index 2 Change D 84 (n=283,274) 0.7735  (6.66709) 0.2663  (6.29393)
15.Secondary Outcome
Title Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale
Hide Description The sleep quantity subscale,which refers to question 2 of the PRO: On average, how many hours did you sleep each night during the past 4 weeks. More hours of sleep indicate better outcome.
Time Frame Baseline, 4 and 12 weeks
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Hide Analysis Population Description
Full analysis set.Higher scores show better outcomes.Excepting the sleep quantity subscale,scoring the MOS requires two steps:(a) assigning a point value to each response and (b) summing the point values for all the items in a given subscale or index. Each subscale and index score is then converted to a T score with a mean of 50 and an SD of 10.
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 302 296
Mean (Standard Deviation)
Unit of Measure: hours of sleep
Sleep quantity Baseline (n=301,295) 6.5565  (1.44169) 6.6203  (1.34895)
Sleep quantity Baseline D28(n=292,285) 6.5702  (1.44879) 6.6351  (1.35775)
Sleep quantity Post D28(n=292,285) 6.5717  (1.54708) 6.6246  (1.46356)
Sleep quantity Change D28(n=292,285) 0.0015  (1.07390) -0.0105  (1.10691)
Sleep quantity Baseline D84(n=285,274) 6.5456  (1.42402) 6.6496  (1.34500)
Sleep quantity Post D84(n=285,274) 6.5561  (1.43780) 6.6569  (1.37648)
Sleep quantity Change D84(n=285,274) 0.0105  (1.12270) 0.0073  (1.18906)
16.Secondary Outcome
Title Summary Statistics of COPD Exacerbations over12 Weeks as Defined by Chronic Pulmonary Disease Tool (EXACT)
Hide Description The EXACT is a 14-item electronic questionnaire designed to detect the frequency, severity, and duration of exacerbations in patients with COPD.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Mean (Standard Deviation)
Unit of Measure: COPD exacerbation per participant
0.2  (0.49) 0.3  (0.56)
17.Secondary Outcome
Title Time to First COPD Exacerbation
Hide Description Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that were event free of a specified event.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants event free
Mild COPD exacerbation
99.3
(98.4 to 100.0)
98.7
(97.4 to 100.0)
Moderate COPD exacerbation
94.5
(92.0 to 97.1)
88.5
(84.9 to 92.1)
Severe COPD exacerbation
98.0
(96.5 to 99.6)
98.3
(96.9 to 99.8)
Moderate or Severe COPD exacerbation
92.9
(89.9 to 95.7)
86.8
(82.9 to 90.6)
Any( mild, moderate,severe)
92.2
(89.2 to 95.2)
85.8
(81.9 to 89.8)
18.Secondary Outcome
Title Annual Rate of COPD Exacerbations
Hide Description Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: COPD Exacerbations per year
Model based estimates
0.354
(0.2210 to 0.5663)
0.659
(0.4523 to 0.9592)
Actual rate exacerbations per year
0.39 [1] 
(NA to NA)
0.73 [1] 
(NA to NA)
[1]
not calculated
19.Secondary Outcome
Title Duration (in Days) of COPD Exacerbations
Hide Description Duration and number of the COPD exacerbation will be analyzed by the negative binomial regression model including treatment, country, smoking status, and COPD severity as factors and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Mean (Standard Deviation)
Unit of Measure: Days
1.4  (6.59) 2.0  (6.28)
20.Secondary Outcome
Title Percentage of Patients With at Least One Exacerbation up to Week 12
Hide Description Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that had an exacerbation up to week 12. Less exacerbations reflect a better outcome.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Measure Type: Number
Unit of Measure: Percentage of participants
7.6 14.1
21.Secondary Outcome
Title Time (in Days) to Permanent Study Discontinuation Due to COPD Exacerbation
Hide Description Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Median (Inter-Quartile Range)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
number of observations is too small to project time to event
22.Secondary Outcome
Title The Percentage of Patients Who Permanently Discontinued Due to COPD Exacerbation
Hide Description Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Measure Type: Number
Unit of Measure: Percentage participants
0.6 1.6
23.Secondary Outcome
Title Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
Hide Description Total amount (in doses) of systemic corticosteroid used to treat COPD exacerbation will be summarized descriptively by treatment group per each systemic corticosteroid.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set consisting of all randomized patients
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 316 313
Mean (Standard Deviation)
Unit of Measure: (Prednisolone dose equivalents) mg
IM Hydrocortisone (mg) (n=1,0) 100  (0) NA [1]   (NA)
IV dexamethasone (mg) (n=0,1) NA [1]   (NA) 4.00  (0)
IV Hydrocortisone (mg) (n=0,1) NA [1]   (NA) 100  (0)
IV Hydrocortisone sodium succinate (mg) (n=2,0) 400.00  (282.843) NA [1]   (NA)
IV methylprenisolone sodium succinate(mg)(n=1,0) 250  (0) NA [1]   (NA)
IV methylprenisolone sodium succinate(ug)(n=0,1) NA [1]   (NA) 80  (0)
IV prednisolone (mg) (n=0,1) NA [1]   (NA) 250  (0)
Oral Budesonide (mg) (n=0,1) NA [1]   (NA) 20  (0)
Oral methylprenisolone (mg) (n=7,13) 16.57  (11.414) 20.31  (9.586)
Oral prednisolone (mg) (n=8,28) 24.38  (9.520) 23.93  (13.060)
Oral prednisone (mg) (n=8,16) 31.25  (11.260) 25.31  (11.176)
Oral prednisone (ug) (n=0,1) NA [1]   (NA) 10  (0)
Inhalation budesonide (mL)(n=0,1) NA [1]   (NA) 0.50  (0)
[1]
no participants in this group
24.Secondary Outcome
Title Plasma Cortisol Concentrations at Each Timepoint
Hide Description Plasma cortisol to be measured in a subset of approximately 60 patients via central laboratory. Blood sample for Plasma cortisol is collected at pre-dose and post dose up to 4 hour on Day 1, up to 12 hours post-dose on Day 28 and Day 84, and 23 hour 35 minute on Day 2, Day 29, and Day 85, and at pre-dose 25 minute on Day 28, and Day 84.
Time Frame Day 1, Day 28, Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.
Arm/Group Title QMF149 Salmeterol Xinafoate/Fluticasone Propionate
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Overall Number of Participants Analyzed 50 47
Mean (Standard Deviation)
Unit of Measure: nmol/mL
Baseline (n=45,41) 328.5  (149.56) 300.2  (107.36)
Day 1 / 15 min (n=44,41) 284.0  (151.96) 247.1  (91.99)
Day 1 / 1 hr (n=44,41) 249.1  (144.90) 223.0  (85.93)
Day 1/ 4 hr (n=44,38) 247.6  (85.90) 205.7  (68.65)
Day 1 /23 hr 35 min (n=38,37) 295.9  (153.80) 274.2  (115.33)
Day 28/-25min (n=40,39) 342.1  (160.16) 295.6  (98.78)
Day 28 / 15 min (n=40,39) 275.0  (140.83) 239.8  (90.14)
Day 28 / 1 hr (n=40,39) 255.9  (134.26) 211.9  (89.41)
Day 28 / 4hr (n=40,38) 241.9  (89.07) 203.6  (108.62)
Day 28 / 11hr 35 min (n=40,37) 124.8  (71.71) 124.1  (72.39)
Day 28/ 23 hr 35 min (n=33,32) 310.6  (99.81) 306.5  (119.33)
Day 84 /-25 min (n=41,37) 337.4  (155.24) 324.1  (104.01)
Day 84/ 15 min (n=40,36) 291.1  (144.26) 265.5  (103.39)
Day 84/ 60 min (n=41,38) 271.3  (158.88) 236.3  (104.06)
Day 84/ 4 hr (n=41,38) 268.4  (136.22) 224.2  (100.36)
Day 84/ 11 hr 35 min (n=41,35) 152.0  (99.66) 147.5  (108.21)
Day 84 / 23 hr 35 min (n=37,36) 339.9  (159.51) 315.9  (104.67)
25.Secondary Outcome
Title Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Hide Description Plasma indacaterol and mometasone furoate is to be measured in a subset of approximately 60 patients via central laboratory. Blood samples are collected at pre-dose on Day 1, 29, and 84; and post dose up to 4 hour on Day 1, up to 12 hours on Day 28 and 84. For sparse pharmacokinetic testing, blood samples will be collected at 23h 35 min post-dose following morning dose administration on Day 28 and 84, in all patients participating in this study.
Time Frame Day 1, 29, 84
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Hide Analysis Population Description
Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.
Arm/Group Title QMF149 (Analyte Mometasone Furoate) QMF149 (Analyte Indacaterol Acetate)
Hide Arm/Group Description:
Assay Analyte: MOMETASONE FUROATE, component of QMF 149 mixture
Assay Analyte: QAB149 (Indacaterol acetate), component of QMF 149 mixture
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: pg/mL
Day 1 time 0 (n=34,44) 4.17  (13.8) 4.32  (12.3)
Day 1 / 15 min (n=44,45) 31.4  (17.9) 111  (52.1)
Day 1 / 1 hr (n=43,45) 44.6  (19.3) 89.7  (41.2)
Day 1/ 4 hr (n=43,45) 26.8  (15.6) 51.4  (33.5)
Day 1 /23 hr 35 min (n=37, 38) 13.1  (16.7) 44.8  (69.9)
Day 28 0 time (n=41,42) 14.5  (18.0) 82.0  (47.4)
Day 28 / 15 min (n= 42,43) 57.5  (31.6) 213  (98.0)
Day 28 / 1 hr (n=41,42) 68.4  (35.0) 194  (99.0)
Day 28 / 4hr (n=42,42) 43.7  (25.7) 132  (67.9)
Day 28 / 11hr 35 min (n=41,42) 19.2  (12.6) 86.6  (40.4)
Day 28/ 23 hr 35 min (n=45,46) 10.8  (7.32) 76.5  (38.1)
Day 84 0 time (n=39,40) 23.1  (30.5) 101  (50.8)
Day 84/ 15 min (n=38,40) 68.1  (41.4) 255  (129)
Day 84/ 60 min (n=38,40) 84.2  (40.6) 241  (119)
Day 84/ 4 hr (n=40,40) 49.9  (26.4) 161  (84.6)
Day 84/ 11 hr 35 min (n=39,41) 25.9  (21.2) 115  (67.5)
Day 84 / 23 hr 35 min (n=44,45) 14.6  (17.8) 98.7  (67.8)
26.Secondary Outcome
Title Pharmacokinetic Parameter: Cmax
Hide Description Maximum observed plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.
Time Frame Day 28, 84
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.
Arm/Group Title QMF149 Analyte: Mometasone Furoate QMF149 Analyte: Indacaterol Acetate
Hide Arm/Group Description:
Mometasone furoate as part of QMF149F
QAB149: indacaterol acetate as a component of QMF149F
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: pg/mL
Day 28 (n=36,35) 73.3  (24.9) 215  (71.5)
Day 84 (n=32,35) 80.2  (23.0) 263  (101)
27.Secondary Outcome
Title Pharmacokinetic Parameter--Tmax
Hide Description Time to reach the maximum plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.
Time Frame Day 28, 84
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.
Arm/Group Title QMF 149 Anaylyte: Mometasone Furorate QMF149 Analyte: Indacaterol Acetate
Hide Arm/Group Description:
Mometasone furoate as a component of QMF149F
QAB149: indacaterol acetate as a component of QMF149F
Overall Number of Participants Analyzed 50 50
Median (Full Range)
Unit of Measure: Hr
Day 28 (n= 36 ,35)
0.250
(0.080 to 3.98)
0.970
(0.230 to 4.15)
Day 84 (n= 32 ,35)
0.250
(0.220 to 11.7)
1.00
(0.220 to 11.7)
28.Secondary Outcome
Title Pharmacokinetic Parameter--AUC0-t
Hide Description Area under the plasma concentration time curve from time zero to time “t” post-dose is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.
Time Frame Day 28, 84
Hide Outcome Measure Data
Hide Analysis Population Description
Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.
Arm/Group Title QMF149 Analyte Mometasone Furoate QMF149 Analyte QAB149
Hide Arm/Group Description:
QMF149 Mometasone furoate analyte from mixture
QMF149 analyte QAB149 ( indacaterol acetate)
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: hr*pg/mL
28 Days (n=35,36) 653  (296) 2400  (771)
84 Days (n=31,33) 693  (297) 2760  (802)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QMF149 SALM/FLUT
Hide Arm/Group Description QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device SALM/FLUT
All-Cause Mortality
QMF149 SALM/FLUT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
QMF149 SALM/FLUT
Affected / at Risk (%) Affected / at Risk (%)
Total   10/316 (3.16%)   19/313 (6.07%) 
Cardiac disorders     
ATRIAL FIBRILLATION  1  1/316 (0.32%)  2/313 (0.64%) 
CORONARY ARTERY DISEASE  1  1/316 (0.32%)  0/313 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  0/316 (0.00%)  1/313 (0.32%) 
COLITIS  1  0/316 (0.00%)  1/313 (0.32%) 
DIARRHOEA  1  1/316 (0.32%)  0/313 (0.00%) 
GASTRIC ULCER HAEMORRHAGE  1  0/316 (0.00%)  1/313 (0.32%) 
HAEMATOCHEZIA  1  1/316 (0.32%)  0/313 (0.00%) 
SMALL INTESTINAL OBSTRUCTION  1  1/316 (0.32%)  0/313 (0.00%) 
General disorders     
MALAISE  1  1/316 (0.32%)  0/313 (0.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS  1  0/316 (0.00%)  1/313 (0.32%) 
Infections and infestations     
INCISION SITE INFECTION  1  1/316 (0.32%)  0/313 (0.00%) 
LOBAR PNEUMONIA  1  0/316 (0.00%)  1/313 (0.32%) 
PNEUMONIA  1  2/316 (0.63%)  0/313 (0.00%) 
SPUTUM PURULENT  1  1/316 (0.32%)  0/313 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/316 (0.32%)  0/313 (0.00%) 
Injury, poisoning and procedural complications     
UPPER LIMB FRACTURE  1  0/316 (0.00%)  1/313 (0.32%) 
Investigations     
ELECTROCARDIOGRAM T WAVE INVERSION  1  0/316 (0.00%)  2/313 (0.64%) 
Musculoskeletal and connective tissue disorders     
OSTEOARTHRITIS  1  1/316 (0.32%)  0/313 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
PLEURAL MESOTHELIOMA MALIGNANT  1  0/316 (0.00%)  1/313 (0.32%) 
Nervous system disorders     
INTRACRANIAL ANEURYSM  1  0/316 (0.00%)  1/313 (0.32%) 
TEMPORAL LOBE EPILEPSY  1  0/316 (0.00%)  1/313 (0.32%) 
TENSION HEADACHE  1  0/316 (0.00%)  1/313 (0.32%) 
Renal and urinary disorders     
HAEMATURIA  1  0/316 (0.00%)  1/313 (0.32%) 
Respiratory, thoracic and mediastinal disorders     
ATELECTASIS  1  0/316 (0.00%)  1/313 (0.32%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  6/316 (1.90%)  5/313 (1.60%) 
COUGH  1  1/316 (0.32%)  0/313 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
QMF149 SALM/FLUT
Affected / at Risk (%) Affected / at Risk (%)
Total   79/316 (25.00%)   83/313 (26.52%) 
Gastrointestinal disorders     
DRY MOUTH  1  4/316 (1.27%)  1/313 (0.32%) 
NAUSEA  1  4/316 (1.27%)  0/313 (0.00%) 
General disorders     
FATIGUE  1  3/316 (0.95%)  4/313 (1.28%) 
PYREXIA  1  6/316 (1.90%)  3/313 (0.96%) 
Infections and infestations     
NASOPHARYNGITIS  1  12/316 (3.80%)  8/313 (2.56%) 
RHINITIS  1  8/316 (2.53%)  2/313 (0.64%) 
UPPER RESPIRATORY TRACT INFECTION  1  4/316 (1.27%)  4/313 (1.28%) 
Investigations     
C-REACTIVE PROTEIN INCREASED  1  6/316 (1.90%)  2/313 (0.64%) 
Musculoskeletal and connective tissue disorders     
MUSCLE SPASMS  1  5/316 (1.58%)  2/313 (0.64%) 
Nervous system disorders     
DIZZINESS  1  4/316 (1.27%)  0/313 (0.00%) 
HEADACHE  1  10/316 (3.16%)  5/313 (1.60%) 
Respiratory, thoracic and mediastinal disorders     
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  19/316 (6.01%)  43/313 (13.74%) 
COUGH  1  9/316 (2.85%)  5/313 (1.60%) 
DYSPNOEA  1  7/316 (2.22%)  10/313 (3.19%) 
OROPHARYNGEAL PAIN  1  6/316 (1.90%)  3/313 (0.96%) 
RHINORRHOEA  1  2/316 (0.63%)  6/313 (1.92%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 (ie, data from all sites) in the clinical trial
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01636076     History of Changes
Other Study ID Numbers: CQMF149F2202
2012-001172-12 ( EudraCT Number )
First Submitted: July 5, 2012
First Posted: July 10, 2012
Results First Submitted: September 10, 2014
Results First Posted: November 17, 2014
Last Update Posted: November 17, 2014