Trial Outcomes & Findings for Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01636076)
NCT ID: NCT01636076
Last Updated: 2014-11-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
629 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-11-17
Participant Flow
Participant milestones
| Measure |
QMF149
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Overall Study
STARTED
|
316
|
313
|
|
Overall Study
COMPLETED
|
299
|
288
|
|
Overall Study
NOT COMPLETED
|
17
|
25
|
Reasons for withdrawal
| Measure |
QMF149
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Overall Study
Terminated by sponsor
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Non-compliance with study treatment
|
1
|
1
|
|
Overall Study
Adverse Event
|
6
|
11
|
|
Overall Study
Withdrawal by Subject
|
7
|
10
|
Baseline Characteristics
Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
Total
n=629 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 7.74 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 7.89 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 7.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
233 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
460 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
273 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
549 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All randomized patients were included in the Full analysis set (FAS)
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85
Full analysis set (n=291,282)
|
1.270 Liters
Standard Error 0.0124
|
1.215 Liters
Standard Error 0.0124
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85
Per protocol set (n=259,251)
|
1.277 Liters
Standard Error 0.0136
|
1.228 Liters
Standard Error 0.0137
|
SECONDARY outcome
Timeframe: Day 1 and Day 85Population: All randomized patients were included in the Safety analysis set (SAF) and Full analysis set (FAS).
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Trough FEV1 After First Dose and After 4 Weeks of Treatment
Day 2 (n=286, 302)
|
1.216 Liters
Standard Error 0.0106
|
1.243 Liters
Standard Error 0.0104
|
|
Trough FEV1 After First Dose and After 4 Weeks of Treatment
Baseline Day 29 (n=293, 296)
|
1.148 Liters
Standard Error 0.0236
|
1.178 Liters
Standard Error 0.0266
|
|
Trough FEV1 After First Dose and After 4 Weeks of Treatment
Day 29 (n=293,296)
|
1.277 Liters
Standard Error 0.0119
|
1.247 Liters
Standard Error 0.0119
|
|
Trough FEV1 After First Dose and After 4 Weeks of Treatment
Day 84 baseline (n=289,287)
|
1.144 Liters
Standard Error 0.0240
|
1.187 Liters
Standard Error 0.0267
|
|
Trough FEV1 After First Dose and After 4 Weeks of Treatment
Day 84 (n=289,287)
|
1.269 Liters
Standard Error 0.0139
|
1.208 Liters
Standard Error 0.0139
|
|
Trough FEV1 After First Dose and After 4 Weeks of Treatment
Baseline Day 2 (n=286, 302)
|
1.147 Liters
Standard Error 0.0237
|
1.167 Liters
Standard Error 0.0264
|
SECONDARY outcome
Timeframe: Day 1 through day 85Population: Full analysis set consisting of all randomized patients
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 1/5min (n=290,298)
|
1.254 liter
Standard Error 0.0069
|
1.198 liter
Standard Error 0.0068
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 1/30 min (n=294,306)
|
1.281 liter
Standard Error 0.0079
|
1.250 liter
Standard Error 0.0087
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 1/60min (n=300,303)
|
1.281 liter
Standard Error 0.0087
|
1.256 liter
Standard Error 0.0087
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 2/ 23 hr 10 min (n=288,295)
|
1.213 liter
Standard Error 0.0108
|
1.239 liter
Standard Error 0.0107
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 2/ 23 hr 45 min (n=297,305)
|
1.215 liter
Standard Error 0.0106
|
1.244 liter
Standard Error 0.0105
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 28/ -50min (n=288,295)
|
1.265 liter
Standard Error 0.0132
|
1.287 liter
Standard Error 0.0139
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 28/ -15min (n=292,290)
|
1.287 liter
Standard Error 0.0132
|
1.235 liter
Standard Error 0.0140
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 28/ 5min (n=290,289)
|
1.329 liter
Standard Error 0.0113
|
1.268 liter
Standard Error 0.0113
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 28/ 30min (n=293,290)
|
1.352 liter
Standard Error 0.0118
|
1.298 liter
Standard Error 0.0118
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 28/ 60min (n=292,290)
|
1.353 liter
Standard Error 0.0123
|
1.298 liter
Standard Error 0.0122
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 29/ 23 hr 10 min (n=285,292)
|
1.269 liter
Standard Error 0.0118
|
1.242 liter
Standard Error 0.0117
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 29/ 23 hr 45 min (n=290,295)
|
1.281 liter
Standard Error 0.0123
|
1.254 liter
Standard Error 0.0122
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 84/ -50 min (n=286,278)
|
1.259 liter
Standard Error 0.0140
|
1.195 liter
Standard Error 0.0141
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 84/ -15 min (n=282,285)
|
1.282 liter
Standard Error 0.0146
|
1.222 liter
Standard Error 0.0147
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 84/ 5 min (n=280,279)
|
1.336 liter
Standard Error 0.0128
|
1.243 liter
Standard Error 0.0128
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 84/ 30 min (n=286,280)
|
1.352 liter
Standard Error 0.0124
|
1.277 liter
Standard Error 0.0124
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 84/ 60 min (n=287,281)
|
1.351 liter
Standard Error 0.0128
|
1.283 liter
Standard Error 0.0128
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 84/ 23 hr 10 min (n=292,291)
|
1.264 liter
Standard Error 0.0125
|
1.212 liter
Standard Error 0.0125
|
|
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Absolute Value Day 84/ 23 hr 45 min (n=291,285)
|
1.273 liter
Standard Error 0.0125
|
1.221 liter
Standard Error 0.0126
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85Population: Full analysis set consisting of all randomized patients
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Forced Vital Capacity (FVC) at Each Timepoint
Baseline (n=316,313)
|
2.460 liters
Standard Deviation 0.6969
|
2.481 liters
Standard Deviation 0.7209
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 1/ 5 min (n=299,298) Change
|
0.179 liters
Standard Deviation 0.2165
|
0.060 liters
Standard Deviation 0.1404
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 1/ 30 min (n=302,306) Change
|
0.207 liters
Standard Deviation 0.2279
|
0.129 liters
Standard Deviation 0.1953
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 1/ 60 min (n=308,303) Change
|
0.222 liters
Standard Deviation 0.2472
|
0.152 liters
Standard Deviation 0.2287
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 28 / -15 min (n=300,291) Change
|
0.161 liters
Standard Deviation 0.3090
|
0.072 liters
Standard Deviation 0.2892
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 28 / 5 min (n=297,290) Change
|
0.238 liters
Standard Deviation 0.3163
|
0.122 liters
Standard Deviation 0.3068
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 29 /23hr 45 min (n=299,296) Change
|
0.133 liters
Standard Deviation 0.3132
|
0.097 liters
Standard Deviation 0.2965
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 84 / -50min (n=295,279) Change
|
0.125 liters
Standard Deviation 0.2979
|
0.144 liters
Standard Deviation 0.3570
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 84 /-15 min (n=291,286) Change
|
0.144 liters
Standard Deviation 0.3234
|
0.049 liters
Standard Deviation 0.3519
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 84 / 5 min (n=288,290) Change
|
0.229 liters
Standard Deviation 0.3370
|
0.076 liters
Standard Deviation 0.3729
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 84 /30 min (n=295,281) Change
|
0.255 liters
Standard Deviation 0.3344
|
0.120 liters
Standard Deviation 0.3537
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 84 / 60 min (n=296,282) Change
|
0.272 liters
Standard Deviation 0.3295
|
0.159 liters
Standard Deviation 0.3648
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 85 / 23 hr 10 min (n=302,292) Change
|
0.113 liters
Standard Deviation 0.3132
|
0.022 liters
Standard Deviation 0.3482
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 85 / 23 hr 45 min (n=301,286) Change
|
0.126 liters
Standard Deviation 0.3206
|
0.035 liters
Standard Deviation 0.3620
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 29 / 23hr 10 min (n=293,293) Change
|
0.121 liters
Standard Deviation 0.2955
|
0.084 liters
Standard Deviation 0.2817
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 28 / 60 min (n=299,292) Change
|
0.279 liters
Standard Deviation 0.3261
|
0.189 liters
Standard Deviation 0.3350
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 1/ 4 hr (n=302,297) Change
|
0.217 liters
Standard Deviation 0.2847
|
0.183 liters
Standard Deviation 0.2611
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 2/ 23hr 10 min (n=297,296) Change
|
0.089 liters
Standard Deviation 0.2518
|
0.092 liters
Standard Deviation 0.2896
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 2/ 23hr 45 min (n=307,306) Change
|
0.083 liters
Standard Deviation 0.2583
|
0.092 liters
Standard Deviation 0.2815
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 28 / -50 min (n=295,296) Change
|
0.132 liters
Standard Deviation 0.2806
|
0.068 liters
Standard Deviation 0.2814
|
|
Forced Vital Capacity (FVC) at Each Timepoint
Day 28 / 30 min (n=301,291) Change
|
0.263 liters
Standard Deviation 0.3169
|
0.168 liters
Standard Deviation 0.3166
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85Population: Full analysis set consisting of all randomized patients
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
FEV1/FVC at Each Timepoint
Day 1 / 4 hr (n=302, 297) change
|
1.045 FEV1/ FVC (%)
Standard Deviation 3.3917
|
1.397 FEV1/ FVC (%)
Standard Deviation 3.2407
|
|
FEV1/FVC at Each Timepoint
Day 1 / 60 min (n=308,303) change
|
1.112 FEV1/ FVC (%)
Standard Deviation 3.1413
|
1.182 FEV1/ FVC (%)
Standard Deviation 3.0612
|
|
FEV1/FVC at Each Timepoint
Day 2 / 23 Hr 10 min (n=297,296) change
|
0.503 FEV1/ FVC (%)
Standard Deviation 3.3450
|
1.042 FEV1/ FVC (%)
Standard Deviation 3.2074
|
|
FEV1/FVC at Each Timepoint
Day 2 / 23 Hr 45 min (n=307,306) change
|
0.583 FEV1/ FVC (%)
Standard Deviation 3.4552
|
1.319 FEV1/ FVC (%)
Standard Deviation 3.1977
|
|
FEV1/FVC at Each Timepoint
Day 28 / -50 min (n=295,296) change
|
1.463 FEV1/ FVC (%)
Standard Deviation 3.7864
|
1.140 FEV1/ FVC (%)
Standard Deviation 3.8900
|
|
FEV1/FVC at Each Timepoint
Day 28 / -15 min (n=300,291) change
|
1.837 FEV1/ FVC (%)
Standard Deviation 3.9769
|
1.495 FEV1/ FVC (%)
Standard Deviation 3.7597
|
|
FEV1/FVC at Each Timepoint
Day 28 / 5 min (n=297,290) change
|
1.951 FEV1/ FVC (%)
Standard Deviation 4.0512
|
1.581 FEV1/ FVC (%)
Standard Deviation 4.006
|
|
FEV1/FVC at Each Timepoint
Day 28 / 30 min (n=301,291) change
|
2.296 FEV1/ FVC (%)
Standard Deviation 4.4904
|
1.873 FEV1/ FVC (%)
Standard Deviation 4.2723
|
|
FEV1/FVC at Each Timepoint
Day 28 / 60 min (n=299,292) change
|
2.525 FEV1/ FVC (%)
Standard Deviation 4.3228
|
2.060 FEV1/ FVC (%)
Standard Deviation 4.4398
|
|
FEV1/FVC at Each Timepoint
Day 28 / 4 hr (n=44,45) change
|
4.034 FEV1/ FVC (%)
Standard Deviation 5.2622
|
2.322 FEV1/ FVC (%)
Standard Deviation 4.0257
|
|
FEV1/FVC at Each Timepoint
Day 28 / 11hr 10 min (n=47,44) change
|
2.553 FEV1/ FVC (%)
Standard Deviation 4.0260
|
1.909 FEV1/ FVC (%)
Standard Deviation 3.9389
|
|
FEV1/FVC at Each Timepoint
Day 28 / 11hr 45 min (n=43,42) change
|
2.791 FEV1/ FVC (%)
Standard Deviation 4.1708
|
2.476 FEV1/ FVC (%)
Standard Deviation 4.3978
|
|
FEV1/FVC at Each Timepoint
Day 84 / 16 hr (n=41,39) change
|
1.415 FEV1/ FVC (%)
Standard Deviation 4.0588
|
1.962 FEV1/ FVC (%)
Standard Deviation 3.6981
|
|
FEV1/FVC at Each Timepoint
Day 84 / 20 hr (n=44,43) change
|
2.364 FEV1/ FVC (%)
Standard Deviation 4.4315
|
1.837 FEV1/ FVC (%)
Standard Deviation 3.7713
|
|
FEV1/FVC at Each Timepoint
Day 84 / 23 hr 10 min (n=302,292) change
|
1.856 FEV1/ FVC (%)
Standard Deviation 4.4315
|
1.414 FEV1/ FVC (%)
Standard Deviation 4.0356
|
|
FEV1/FVC at Each Timepoint
Day 84 / 23 hr 45 min (n=301,286) change
|
2.098 FEV1/ FVC (%)
Standard Deviation 4.3676
|
1.593 FEV1/ FVC (%)
Standard Deviation 4.2110
|
|
FEV1/FVC at Each Timepoint
Day 1 / 30 min (n=302,306) change
|
0.955 FEV1/ FVC (%)
Standard Deviation 3.0166
|
0.879 FEV1/ FVC (%)
Standard Deviation 2.7281
|
|
FEV1/FVC at Each Timepoint
Baseline (n=316, 313)
|
46.786 FEV1/ FVC (%)
Standard Deviation 10.0306
|
46.859 FEV1/ FVC (%)
Standard Deviation 10.0392
|
|
FEV1/FVC at Each Timepoint
Day 1 / 5 min (n=299, 298) change
|
0.488 FEV1/ FVC (%)
Standard Deviation 2.9633
|
0.047 FEV1/ FVC (%)
Standard Deviation 2.1366
|
|
FEV1/FVC at Each Timepoint
Day 28 / 16 hr (n=40,41) change
|
2.250 FEV1/ FVC (%)
Standard Deviation 3.4006
|
2.305 FEV1/ FVC (%)
Standard Deviation 4.3111
|
|
FEV1/FVC at Each Timepoint
Day 28 / 20 hr (n=43,44) change
|
2.535 FEV1/ FVC (%)
Standard Deviation 3.5379
|
2.250 FEV1/ FVC (%)
Standard Deviation 3.9935
|
|
FEV1/FVC at Each Timepoint
Day 29 / 23 hr 10 min (n=293,293) change
|
1.771 FEV1/ FVC (%)
Standard Deviation 4.0730
|
1.319 FEV1/ FVC (%)
Standard Deviation 3.8200
|
|
FEV1/FVC at Each Timepoint
Day 29 / 23 hr 45 min (n=299,296) change
|
2.000 FEV1/ FVC (%)
Standard Deviation 4.0562
|
1.566 FEV1/ FVC (%)
Standard Deviation 3.9704
|
|
FEV1/FVC at Each Timepoint
Day 84 / -50 min (n=295,279) change
|
1.449 FEV1/ FVC (%)
Standard Deviation 4.1145
|
1.068 FEV1/ FVC (%)
Standard Deviation 4.1776
|
|
FEV1/FVC at Each Timepoint
Day 84 / -15 min (n=291,286) change
|
2.155 FEV1/ FVC (%)
Standard Deviation 4.0673
|
1.584 FEV1/ FVC (%)
Standard Deviation 4.3278
|
|
FEV1/FVC at Each Timepoint
Day 84 / 5 min (n=288,280) change
|
2.332 FEV1/ FVC (%)
Standard Deviation 4.1032
|
1.796 FEV1/ FVC (%)
Standard Deviation 4.2310
|
|
FEV1/FVC at Each Timepoint
Day 84 / 30 min (n=295,281) change
|
2.420 FEV1/ FVC (%)
Standard Deviation 4.3561
|
2.062 FEV1/ FVC (%)
Standard Deviation 4.3941
|
|
FEV1/FVC at Each Timepoint
Day 84 / 60 min (n=296,282) change
|
2.571 FEV1/ FVC (%)
Standard Deviation 4.4128
|
2.067 FEV1/ FVC (%)
Standard Deviation 4.3512
|
|
FEV1/FVC at Each Timepoint
Day 84 / 4 hr (n=45,44) change
|
2.389 FEV1/ FVC (%)
Standard Deviation 3.7079
|
2.682 FEV1/ FVC (%)
Standard Deviation 4.3269
|
|
FEV1/FVC at Each Timepoint
Day 84 / 11hr 10 min (n=45,43) change
|
1.944 FEV1/ FVC (%)
Standard Deviation 4.0833
|
2.105 FEV1/ FVC (%)
Standard Deviation 3.8754
|
|
FEV1/FVC at Each Timepoint
Day 84 / 11 hr 45 min (n=39,39) change
|
2.538 FEV1/ FVC (%)
Standard Deviation 3.7895
|
2.295 FEV1/ FVC (%)
Standard Deviation 4.1147
|
SECONDARY outcome
Timeframe: Day 1Population: Full analysis set consisting of all randomized patients
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min - 4h)
Day 1 baseline (n=303,311)
|
1.142 Liters * hours
Standard Error 0.0233
|
1.169 Liters * hours
Standard Error 0.0259
|
|
FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min - 4h)
Day 1 post (n=303,311)
|
1.277 Liters * hours
Standard Error 0.0086
|
1.260 Liters * hours
Standard Error 0.0085
|
SECONDARY outcome
Timeframe: Day 1(Baseline), Day 28, Day 84Population: 24 hr profiling subgroup
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.
Outcome measures
| Measure |
QMF149
n=50 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=50 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
FEV1 AUC (5 Min-4 h),
Day 1 baseline (n=46,47)
|
1.302 Liters*hours
Standard Error 0.0278
|
1.331 Liters*hours
Standard Error 0.0282
|
|
FEV1 AUC (5 Min-4 h),
Day 28 (n=45,46)
|
1.410 Liters*hours
Standard Error 0.0353
|
1.355 Liters*hours
Standard Error 0.0355
|
|
FEV1 AUC (5 Min-4 h),
Day 84 (n=44,46)
|
1.387 Liters*hours
Standard Error 0.0401
|
1.372 Liters*hours
Standard Error 0.0401
|
SECONDARY outcome
Timeframe: Day 28, Day 84Population: 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).
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.
Outcome measures
| Measure |
QMF149
n=50 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=50 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
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)
Day 28 (n=45,46)
|
1.352 Liters*hours
Standard Error 0.0428
|
1.298 Liters*hours
Standard Error 0.0431
|
|
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)
Day 85 (n=47,47)
|
1.317 Liters*hours
Standard Error 0.0454
|
1.303 Liters*hours
Standard Error 0.0459
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set consisting of all randomized patients
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
The Usage of Rescue Medication (Short Acting β2-agonist)
Nighttime Change Weeks 1-12 (n=281,271)
|
-0.452 Number of puffs
Standard Error 0.0748
|
-0.308 Number of puffs
Standard Error 0.0751
|
|
The Usage of Rescue Medication (Short Acting β2-agonist)
Daily Change Weeks 1-12 (n-281,274)
|
-1.064 Number of puffs
Standard Error 0.1615
|
-0.593 Number of puffs
Standard Error 0.1621
|
|
The Usage of Rescue Medication (Short Acting β2-agonist)
Daytime Change Weeks 1-12 (n=276-272)
|
-0.625 Number of puffs
Standard Error 0.1021
|
-0.300 Number of puffs
Standard Error 0.1026
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Full analysis set consisting of all randomized patients
This value represents the percent of days in the study where no rescue medication was needed.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
The Overall Change in Usage of Rescue Medication (Short Acting β2-agonist) .
|
8.796 % of days
Standard Error 2.3845
|
2.538 % of days
Standard Error 2.3980
|
SECONDARY outcome
Timeframe: 4 and 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire)
Day 28 Post (n=304,295)
|
40.95 Total Score
Standard Deviation 18.527
|
42.18 Total Score
Standard Deviation 18.101
|
|
Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire)
Day 28 Change (n=304,295)
|
-1.92 Total Score
Standard Deviation 11.383
|
-0.29 Total Score
Standard Deviation 12.145
|
|
Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire)
Day 84 Baseline (n=297,284)
|
42.57 Total Score
Standard Deviation 18.322
|
42.03 Total Score
Standard Deviation 18.099
|
|
Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire)
Day 84 Post (n=297,284)
|
39.81 Total Score
Standard Deviation 19.057
|
41.01 Total Score
Standard Deviation 18.553
|
|
Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire)
Day 84 Change (n=297,284)
|
-2.76 Total Score
Standard Deviation 13.062
|
-1.02 Total Score
Standard Deviation 12.178
|
|
Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire)
Baseline (n=314, 308)
|
43.05 Total Score
Standard Deviation 18.515
|
42.28 Total Score
Standard Deviation 17.941
|
|
Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire)
Day 28 Baseline (n=304,295)
|
42.87 Total Score
Standard Deviation 18.392
|
42.47 Total Score
Standard Deviation 18.051
|
SECONDARY outcome
Timeframe: 4 and 12 weeksPopulation: 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.
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
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Analysis of the Proportion of Subjects With a Clinically Important Improvement of >=1 Point in the TDI (Transitional Dyspnoea Index)Focal Score by Visit
Day 28 Change from baseline (n=291,294)
|
43.3 (%) showing clinical improvement
0.1314 • Interval 0.79 to 1.68
|
40.5 (%) showing clinical improvement
0.1331
|
|
Analysis of the Proportion of Subjects With a Clinically Important Improvement of >=1 Point in the TDI (Transitional Dyspnoea Index)Focal Score by Visit
Day 84 Change from baseline (n=287,283)
|
52.6 (%) showing clinical improvement
0.1330 • Interval 0.99 to 2.05
|
45.9 (%) showing clinical improvement
0.1390
|
SECONDARY outcome
Timeframe: Baseline, 4 and 12 weeksPopulation: Full analysis set consisting of all randomized patients
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Patient Reported Outcome Measures: COPD Assessment Test
Baseline (n= 311,308)
|
16.3 Units on a scale
Standard Deviation 7.60
|
16.2 Units on a scale
Standard Deviation 7.48
|
|
Patient Reported Outcome Measures: COPD Assessment Test
Day 28 baseline (n=303,298)
|
16.2 Units on a scale
Standard Deviation 7.58
|
16.2 Units on a scale
Standard Deviation 7.48
|
|
Patient Reported Outcome Measures: COPD Assessment Test
Day 28 Post (n=303,298)
|
15.8 Units on a scale
Standard Deviation 7.63
|
16.8 Units on a scale
Standard Deviation 7.75
|
|
Patient Reported Outcome Measures: COPD Assessment Test
Day 84 change (n=295,285)
|
-0.4 Units on a scale
Standard Deviation 5.77
|
0.2 Units on a scale
Standard Deviation 5.84
|
|
Patient Reported Outcome Measures: COPD Assessment Test
Day 28 Change (n=303,298)
|
-0.4 Units on a scale
Standard Deviation 5.56
|
0.6 Units on a scale
Standard Deviation 4.94
|
|
Patient Reported Outcome Measures: COPD Assessment Test
Day 84 Baseline (n=295,285)
|
15.9 Units on a scale
Standard Deviation 7.54
|
16.1 Units on a scale
Standard Deviation 8.38
|
|
Patient Reported Outcome Measures: COPD Assessment Test
Day 84 Post (n=295,285)
|
15.5 Units on a scale
Standard Deviation 7.56
|
16.3 Units on a scale
Standard Deviation 8.38
|
SECONDARY outcome
Timeframe: Baseline, 4 and 12 weeksPopulation: Full analysis set.
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.
Outcome measures
| Measure |
QMF149
n=302 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=296 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep disturbance Day 28 Baseline (n=290,285)
|
49.6833 Units on a scale
Standard Deviation 8.57069
|
49.7616 Units on a scale
Standard Deviation 8.49307
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep disturbance Baseline (n=299,295)
|
49.6423 Units on a scale
Standard Deviation 8.50059
|
49.9292 Units on a scale
Standard Deviation 8.51330
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep disturbance Day 28 post (n=290,285)
|
50.9323 Units on a scale
Standard Deviation 8.92540
|
50.0858 Units on a scale
Standard Deviation 8.77110
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep disturbance Day 28 change (n=290,285)
|
1.2490 Units on a scale
Standard Deviation 5.67591
|
0.3242 Units on a scale
Standard Deviation 6.63156
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep snoring Day 28 Baseline (n=290,285)
|
48.8234 Units on a scale
Standard Deviation 9.40239
|
49.7733 Units on a scale
Standard Deviation 9.23030
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep snoring Day 28 Post (n=290,285)
|
49.3476 Units on a scale
Standard Deviation 9.37744
|
49.5067 Units on a scale
Standard Deviation 9.39012
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep snoring Day 28 change(n=290,285)
|
0.5241 Units on a scale
Standard Deviation 6.70023
|
-0.2667 Units on a scale
Standard Deviation 7.06825
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep snoring Day 84 post (n=283,274)
|
49.4591 Units on a scale
Standard Deviation 9.29113
|
49.6108 Units on a scale
Standard Deviation 9.51632
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep shortness of breath Baseline (n=302,295)
|
44.5221 Units on a scale
Standard Deviation 13.28329
|
45.4259 Units on a scale
Standard Deviation 11.51560
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep shortness of breath D 28 Bseline(n=293,285)
|
44.6348 Units on a scale
Standard Deviation 13.15710
|
45.3292 Units on a scale
Standard Deviation 11.48556
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep shortness of breath D 28 post (n=293,285)
|
45.8814 Units on a scale
Standard Deviation 11.85664
|
45.5774 Units on a scale
Standard Deviation 11.65379
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep shortness of breath D 84 Bseline (n=287,274)
|
44.8645 Units on a scale
Standard Deviation 12.99605
|
45.3180 Units on a scale
Standard Deviation 11.37006
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep shortness of breath D 84 change (n=287,274)
|
0.9031 Units on a scale
Standard Deviation 12.11351
|
0.3870 Units on a scale
Standard Deviation 10.97093
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep adequacy baseline (n=300,295)
|
54.9999 Units on a scale
Standard Deviation 9.85865
|
54.9725 Units on a scale
Standard Deviation 9.41704
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep adequacy baseline D 28 (n=291,285)
|
55.0531 Units on a scale
Standard Deviation 9.80609
|
55.0679 Units on a scale
Standard Deviation 9.30955
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep adequacy Post D 28 (n=291,285)
|
55.2032 Units on a scale
Standard Deviation 10.04281
|
54.8296 Units on a scale
Standard Deviation 10.21011
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep adequacy Change D 28 (n=291,285)
|
0.1501 Units on a scale
Standard Deviation 9.83920
|
-0.2383 Units on a scale
Standard Deviation 9.21250
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep adequacy baseline D 84 (n=284,274)
|
55.2125 Units on a scale
Standard Deviation 9.81055
|
55.1084 Units on a scale
Standard Deviation 9.20723
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep adequacy Post D 84 (n=284,274)
|
55.2467 Units on a scale
Standard Deviation 10.00283
|
54.5424 Units on a scale
Standard Deviation 9.96705
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep adequacy change D 84 (n=284,274)
|
0.0342 Units on a scale
Standard Deviation 8.81793
|
-0.5659 Units on a scale
Standard Deviation 8.57800
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep somnolence baseline (n=302,296)
|
47.6646 Units on a scale
Standard Deviation 9.56376
|
49.1709 Units on a scale
Standard Deviation 9.56807
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep somnolence baseline D28 (n=290,285)
|
47.8711 Units on a scale
Standard Deviation 9.48940
|
49.1092 Units on a scale
Standard Deviation 9.58808
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep somnolence baseline D84 (n=284,274)
|
47.7821 Units on a scale
Standard Deviation 9.53639
|
48.9335 Units on a scale
Standard Deviation 9.55603
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep somnolence post D84 (n=284,274)
|
48.2568 Units on a scale
Standard Deviation 10.36223
|
49.0461 Units on a scale
Standard Deviation 9.54132
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep somnolence change D84 (n=284,274)
|
0.4747 Units on a scale
Standard Deviation 8.11292
|
0.1126 Units on a scale
Standard Deviation 7.83662
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 1 Baseline (n=300,295)
|
50.4795 Units on a scale
Standard Deviation 9.72203
|
50.8382 Units on a scale
Standard Deviation 9.16082
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 1 Baseline D28 (n=290,285)
|
50.6034 Units on a scale
Standard Deviation 9.67464
|
50.7911 Units on a scale
Standard Deviation 9.13425
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 1 Post D28 (n=290,285)
|
51.4799 Units on a scale
Standard Deviation 9.86137
|
50.7836 Units on a scale
Standard Deviation 10.02742
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 1 Change D28 (n=290,285)
|
0.8764 Units on a scale
Standard Deviation 7.03960
|
-0.0074 Units on a scale
Standard Deviation 7.73909
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 1 Baseline D84 (n=284,274)
|
50.7327 Units on a scale
Standard Deviation 9.64776
|
50.6951 Units on a scale
Standard Deviation 9.09626
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 1 Post D84 (n=284,274)
|
51.3590 Units on a scale
Standard Deviation 10.16584
|
50.9888 Units on a scale
Standard Deviation 9.54642
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 1 Change D84 (n=284,274)
|
0.6263 Units on a scale
Standard Deviation 7.22742
|
0.2938 Units on a scale
Standard Deviation 7.08082
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 2 baseline (n=299,295)
|
50.4610 Units on a scale
Standard Deviation 9.14154
|
51.0701 Units on a scale
Standard Deviation 8.62899
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 2 baseline D 28 (n=289,285)
|
50.5720 Units on a scale
Standard Deviation 9.15508
|
50.9923 Units on a scale
Standard Deviation 8.60656
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 2 Post D 28 (n=289,285)
|
51.5578 Units on a scale
Standard Deviation 9.43365
|
51.0116 Units on a scale
Standard Deviation 9.33837
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 2 Change D 28 (n=289,285)
|
0.9858 Units on a scale
Standard Deviation 6.00711
|
0.0193 Units on a scale
Standard Deviation 6.99119
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 2 Baseline D 84 (n=283,274)
|
50.6880 Units on a scale
Standard Deviation 9.16092
|
50.8848 Units on a scale
Standard Deviation 8.58893
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 2 Post D 84 (n=283,274)
|
51.4615 Units on a scale
Standard Deviation 9.79518
|
51.1511 Units on a scale
Standard Deviation 9.09673
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep Problems Index 2 Change D 84 (n=283,274)
|
0.7735 Units on a scale
Standard Deviation 6.66709
|
0.2663 Units on a scale
Standard Deviation 6.29393
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep disturbance Day 84 Baseline (n=283,274)
|
49.7622 Units on a scale
Standard Deviation 8.61100
|
49.6634 Units on a scale
Standard Deviation 8.41228
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep disturbance Day 84 Post (n=283,274)
|
50.7508 Units on a scale
Standard Deviation 9.22016
|
50.2380 Units on a scale
Standard Deviation 9.07204
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep disturbance Day 84 Change (n=283,274)
|
0.9887 Units on a scale
Standard Deviation 6.52972
|
0.5745 Units on a scale
Standard Deviation 6.45362
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep snoring Baseline (n=299,295)
|
48.8815 Units on a scale
Standard Deviation 9.32313
|
49.8895 Units on a scale
Standard Deviation 9.18885
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep snoring Day 84 Baseline (n=283,274)
|
48.8414 Units on a scale
Standard Deviation 9.29113
|
49.6385 Units on a scale
Standard Deviation 9.19681
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep snoring Day 84 change (n=283,274)
|
0.6177 Units on a scale
Standard Deviation 7.42456
|
-0.0277 Units on a scale
Standard Deviation 8.266668
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep shortness of breath D 28 change (n=293,285)
|
1.2466 Units on a scale
Standard Deviation 12.21272
|
0.2481 Units on a scale
Standard Deviation 11.44262
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep shortness of breath D 84 post (n=287,274)
|
45.7676 Units on a scale
Standard Deviation 13.20151
|
45.7049 Units on a scale
Standard Deviation 11.84910
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep somnolence post D28 (n=290,285)
|
48.4429 Units on a scale
Standard Deviation 9.93046
|
48.6761 Units on a scale
Standard Deviation 10.17850
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Sleep somnolence change D28 (n=290,285)
|
0.5718 Units on a scale
Standard Deviation 7.91162
|
-0.4331 Units on a scale
Standard Deviation 8.67719
|
SECONDARY outcome
Timeframe: Baseline, 4 and 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
QMF149
n=302 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=296 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale
Sleep quantity Baseline (n=301,295)
|
6.5565 hours of sleep
Standard Deviation 1.44169
|
6.6203 hours of sleep
Standard Deviation 1.34895
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale
Sleep quantity Baseline D28(n=292,285)
|
6.5702 hours of sleep
Standard Deviation 1.44879
|
6.6351 hours of sleep
Standard Deviation 1.35775
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale
Sleep quantity Post D28(n=292,285)
|
6.5717 hours of sleep
Standard Deviation 1.54708
|
6.6246 hours of sleep
Standard Deviation 1.46356
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale
Sleep quantity Change D28(n=292,285)
|
0.0015 hours of sleep
Standard Deviation 1.07390
|
-0.0105 hours of sleep
Standard Deviation 1.10691
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale
Sleep quantity Baseline D84(n=285,274)
|
6.5456 hours of sleep
Standard Deviation 1.42402
|
6.6496 hours of sleep
Standard Deviation 1.34500
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale
Sleep quantity Post D84(n=285,274)
|
6.5561 hours of sleep
Standard Deviation 1.43780
|
6.6569 hours of sleep
Standard Deviation 1.37648
|
|
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale
Sleep quantity Change D84(n=285,274)
|
0.0105 hours of sleep
Standard Deviation 1.12270
|
0.0073 hours of sleep
Standard Deviation 1.18906
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set consisting of all randomized patients
The EXACT is a 14-item electronic questionnaire designed to detect the frequency, severity, and duration of exacerbations in patients with COPD.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Summary Statistics of COPD Exacerbations over12 Weeks as Defined by Chronic Pulmonary Disease Tool (EXACT)
|
0.2 COPD exacerbation per participant
Standard Deviation 0.49
|
0.3 COPD exacerbation per participant
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set consisting of all randomized patients
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Time to First COPD Exacerbation
Mild COPD exacerbation
|
99.3 Percentage of participants event free
Interval 98.4 to 100.0
|
98.7 Percentage of participants event free
Interval 97.4 to 100.0
|
|
Time to First COPD Exacerbation
Moderate COPD exacerbation
|
94.5 Percentage of participants event free
Interval 92.0 to 97.1
|
88.5 Percentage of participants event free
Interval 84.9 to 92.1
|
|
Time to First COPD Exacerbation
Severe COPD exacerbation
|
98.0 Percentage of participants event free
Interval 96.5 to 99.6
|
98.3 Percentage of participants event free
Interval 96.9 to 99.8
|
|
Time to First COPD Exacerbation
Moderate or Severe COPD exacerbation
|
92.9 Percentage of participants event free
Interval 89.9 to 95.7
|
86.8 Percentage of participants event free
Interval 82.9 to 90.6
|
|
Time to First COPD Exacerbation
Any( mild, moderate,severe)
|
92.2 Percentage of participants event free
Interval 89.2 to 95.2
|
85.8 Percentage of participants event free
Interval 81.9 to 89.8
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set consisting of all randomized patients
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Annual Rate of COPD Exacerbations
Model based estimates
|
0.354 COPD Exacerbations per year
Interval 0.221 to 0.5663
|
0.659 COPD Exacerbations per year
Interval 0.4523 to 0.9592
|
|
Annual Rate of COPD Exacerbations
Actual rate exacerbations per year
|
0.39 COPD Exacerbations per year
not calculated
|
0.73 COPD Exacerbations per year
not calculated
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set consisting of all randomized patients
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Duration (in Days) of COPD Exacerbations
|
1.4 Days
Standard Deviation 6.59
|
2.0 Days
Standard Deviation 6.28
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set consisting of all randomized patients
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Percentage of Patients With at Least One Exacerbation up to Week 12
|
7.6 Percentage of participants
|
14.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set consisting of all randomized patients
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Time (in Days) to Permanent Study Discontinuation Due to COPD Exacerbation
|
NA Days
number of observations is too small to project time to event
|
NA Days
number of observations is too small to project time to event
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set consisting of all randomized patients
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.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
The Percentage of Patients Who Permanently Discontinued Due to COPD Exacerbation
|
0.6 Percentage participants
|
1.6 Percentage participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set consisting of all randomized patients
Total amount (in doses) of systemic corticosteroid used to treat COPD exacerbation will be summarized descriptively by treatment group per each systemic corticosteroid.
Outcome measures
| Measure |
QMF149
n=316 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=313 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
IV Hydrocortisone sodium succinate (mg) (n=2,0)
|
400.00 (Prednisolone dose equivalents) mg
Standard Deviation 282.843
|
NA (Prednisolone dose equivalents) mg
Standard Deviation NA
no participants in this group
|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
IV methylprenisolone sodium succinate(mg)(n=1,0)
|
250 (Prednisolone dose equivalents) mg
Standard Deviation 0
|
NA (Prednisolone dose equivalents) mg
Standard Deviation NA
no participants in this group
|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
IV methylprenisolone sodium succinate(ug)(n=0,1)
|
NA (Prednisolone dose equivalents) mg
Standard Deviation NA
no participants in this group
|
80 (Prednisolone dose equivalents) mg
Standard Deviation 0
|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
IV prednisolone (mg) (n=0,1)
|
NA (Prednisolone dose equivalents) mg
Standard Deviation NA
no participants in this group
|
250 (Prednisolone dose equivalents) mg
Standard Deviation 0
|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
Oral Budesonide (mg) (n=0,1)
|
NA (Prednisolone dose equivalents) mg
Standard Deviation NA
no participants in this group
|
20 (Prednisolone dose equivalents) mg
Standard Deviation 0
|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
Oral prednisolone (mg) (n=8,28)
|
24.38 (Prednisolone dose equivalents) mg
Standard Deviation 9.520
|
23.93 (Prednisolone dose equivalents) mg
Standard Deviation 13.060
|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
Oral prednisone (mg) (n=8,16)
|
31.25 (Prednisolone dose equivalents) mg
Standard Deviation 11.260
|
25.31 (Prednisolone dose equivalents) mg
Standard Deviation 11.176
|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
IM Hydrocortisone (mg) (n=1,0)
|
100 (Prednisolone dose equivalents) mg
Standard Deviation 0
|
NA (Prednisolone dose equivalents) mg
Standard Deviation NA
no participants in this group
|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
IV dexamethasone (mg) (n=0,1)
|
NA (Prednisolone dose equivalents) mg
Standard Deviation NA
no participants in this group
|
4.00 (Prednisolone dose equivalents) mg
Standard Deviation 0
|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
IV Hydrocortisone (mg) (n=0,1)
|
NA (Prednisolone dose equivalents) mg
Standard Deviation NA
no participants in this group
|
100 (Prednisolone dose equivalents) mg
Standard Deviation 0
|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
Oral methylprenisolone (mg) (n=7,13)
|
16.57 (Prednisolone dose equivalents) mg
Standard Deviation 11.414
|
20.31 (Prednisolone dose equivalents) mg
Standard Deviation 9.586
|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
Oral prednisone (ug) (n=0,1)
|
NA (Prednisolone dose equivalents) mg
Standard Deviation NA
no participants in this group
|
10 (Prednisolone dose equivalents) mg
Standard Deviation 0
|
|
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
Inhalation budesonide (mL)(n=0,1)
|
NA (Prednisolone dose equivalents) mg
Standard Deviation NA
no participants in this group
|
0.50 (Prednisolone dose equivalents) mg
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 1, Day 28, Day 84Population: 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.
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.
Outcome measures
| Measure |
QMF149
n=50 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=47 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 1 / 15 min (n=44,41)
|
284.0 nmol/mL
Standard Deviation 151.96
|
247.1 nmol/mL
Standard Deviation 91.99
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 1 / 1 hr (n=44,41)
|
249.1 nmol/mL
Standard Deviation 144.90
|
223.0 nmol/mL
Standard Deviation 85.93
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 1/ 4 hr (n=44,38)
|
247.6 nmol/mL
Standard Deviation 85.90
|
205.7 nmol/mL
Standard Deviation 68.65
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 1 /23 hr 35 min (n=38,37)
|
295.9 nmol/mL
Standard Deviation 153.80
|
274.2 nmol/mL
Standard Deviation 115.33
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 28/-25min (n=40,39)
|
342.1 nmol/mL
Standard Deviation 160.16
|
295.6 nmol/mL
Standard Deviation 98.78
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 28/ 23 hr 35 min (n=33,32)
|
310.6 nmol/mL
Standard Deviation 99.81
|
306.5 nmol/mL
Standard Deviation 119.33
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 84 /-25 min (n=41,37)
|
337.4 nmol/mL
Standard Deviation 155.24
|
324.1 nmol/mL
Standard Deviation 104.01
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 84/ 15 min (n=40,36)
|
291.1 nmol/mL
Standard Deviation 144.26
|
265.5 nmol/mL
Standard Deviation 103.39
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 84/ 11 hr 35 min (n=41,35)
|
152.0 nmol/mL
Standard Deviation 99.66
|
147.5 nmol/mL
Standard Deviation 108.21
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 84 / 23 hr 35 min (n=37,36)
|
339.9 nmol/mL
Standard Deviation 159.51
|
315.9 nmol/mL
Standard Deviation 104.67
|
|
Plasma Cortisol Concentrations at Each Timepoint
Baseline (n=45,41)
|
328.5 nmol/mL
Standard Deviation 149.56
|
300.2 nmol/mL
Standard Deviation 107.36
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 28 / 15 min (n=40,39)
|
275.0 nmol/mL
Standard Deviation 140.83
|
239.8 nmol/mL
Standard Deviation 90.14
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 28 / 1 hr (n=40,39)
|
255.9 nmol/mL
Standard Deviation 134.26
|
211.9 nmol/mL
Standard Deviation 89.41
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 28 / 4hr (n=40,38)
|
241.9 nmol/mL
Standard Deviation 89.07
|
203.6 nmol/mL
Standard Deviation 108.62
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 28 / 11hr 35 min (n=40,37)
|
124.8 nmol/mL
Standard Deviation 71.71
|
124.1 nmol/mL
Standard Deviation 72.39
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 84/ 60 min (n=41,38)
|
271.3 nmol/mL
Standard Deviation 158.88
|
236.3 nmol/mL
Standard Deviation 104.06
|
|
Plasma Cortisol Concentrations at Each Timepoint
Day 84/ 4 hr (n=41,38)
|
268.4 nmol/mL
Standard Deviation 136.22
|
224.2 nmol/mL
Standard Deviation 100.36
|
SECONDARY outcome
Timeframe: Day 1, 29, 84Population: 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.
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.
Outcome measures
| Measure |
QMF149
n=50 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=50 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 1 time 0 (n=34,44)
|
4.17 pg/mL
Standard Deviation 13.8
|
4.32 pg/mL
Standard Deviation 12.3
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 1 / 15 min (n=44,45)
|
31.4 pg/mL
Standard Deviation 17.9
|
111 pg/mL
Standard Deviation 52.1
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 1 / 1 hr (n=43,45)
|
44.6 pg/mL
Standard Deviation 19.3
|
89.7 pg/mL
Standard Deviation 41.2
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 1/ 4 hr (n=43,45)
|
26.8 pg/mL
Standard Deviation 15.6
|
51.4 pg/mL
Standard Deviation 33.5
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 1 /23 hr 35 min (n=37, 38)
|
13.1 pg/mL
Standard Deviation 16.7
|
44.8 pg/mL
Standard Deviation 69.9
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 28 / 15 min (n= 42,43)
|
57.5 pg/mL
Standard Deviation 31.6
|
213 pg/mL
Standard Deviation 98.0
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 28 / 1 hr (n=41,42)
|
68.4 pg/mL
Standard Deviation 35.0
|
194 pg/mL
Standard Deviation 99.0
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 28 / 4hr (n=42,42)
|
43.7 pg/mL
Standard Deviation 25.7
|
132 pg/mL
Standard Deviation 67.9
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 28 / 11hr 35 min (n=41,42)
|
19.2 pg/mL
Standard Deviation 12.6
|
86.6 pg/mL
Standard Deviation 40.4
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 28/ 23 hr 35 min (n=45,46)
|
10.8 pg/mL
Standard Deviation 7.32
|
76.5 pg/mL
Standard Deviation 38.1
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 84 0 time (n=39,40)
|
23.1 pg/mL
Standard Deviation 30.5
|
101 pg/mL
Standard Deviation 50.8
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 84/ 15 min (n=38,40)
|
68.1 pg/mL
Standard Deviation 41.4
|
255 pg/mL
Standard Deviation 129
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 84/ 60 min (n=38,40)
|
84.2 pg/mL
Standard Deviation 40.6
|
241 pg/mL
Standard Deviation 119
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 84/ 4 hr (n=40,40)
|
49.9 pg/mL
Standard Deviation 26.4
|
161 pg/mL
Standard Deviation 84.6
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 84/ 11 hr 35 min (n=39,41)
|
25.9 pg/mL
Standard Deviation 21.2
|
115 pg/mL
Standard Deviation 67.5
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 84 / 23 hr 35 min (n=44,45)
|
14.6 pg/mL
Standard Deviation 17.8
|
98.7 pg/mL
Standard Deviation 67.8
|
|
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Day 28 0 time (n=41,42)
|
14.5 pg/mL
Standard Deviation 18.0
|
82.0 pg/mL
Standard Deviation 47.4
|
SECONDARY outcome
Timeframe: Day 28, 84Population: 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.
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.
Outcome measures
| Measure |
QMF149
n=50 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=50 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Pharmacokinetic Parameter: Cmax
Day 28 (n=36,35)
|
73.3 pg/mL
Standard Deviation 24.9
|
215 pg/mL
Standard Deviation 71.5
|
|
Pharmacokinetic Parameter: Cmax
Day 84 (n=32,35)
|
80.2 pg/mL
Standard Deviation 23.0
|
263 pg/mL
Standard Deviation 101
|
SECONDARY outcome
Timeframe: Day 28, 84Population: 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.
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.
Outcome measures
| Measure |
QMF149
n=50 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=50 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Pharmacokinetic Parameter--Tmax
Day 28 (n= 36 ,35)
|
0.250 Hr
Full Range 0.833 • Interval 0.08 to 3.98
|
0.970 Hr
Full Range 0.662 • Interval 0.23 to 4.15
|
|
Pharmacokinetic Parameter--Tmax
Day 84 (n= 32 ,35)
|
0.250 Hr
Full Range 1.92 • Interval 0.22 to 11.7
|
1.00 Hr
Full Range 1.92 • Interval 0.22 to 11.7
|
SECONDARY outcome
Timeframe: Day 28, 84Population: 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.
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.
Outcome measures
| Measure |
QMF149
n=50 Participants
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
Salmeterol Xinafoate/Fluticasone Propionate
n=50 Participants
Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
|
|---|---|---|
|
Pharmacokinetic Parameter--AUC0-t
84 Days (n=31,33)
|
693 hr*pg/mL
Standard Deviation 297
|
2760 hr*pg/mL
Standard Deviation 802
|
|
Pharmacokinetic Parameter--AUC0-t
28 Days (n=35,36)
|
653 hr*pg/mL
Standard Deviation 296
|
2400 hr*pg/mL
Standard Deviation 771
|
Adverse Events
QMF149
Serious events: 10 serious events
Other events: 79 other events
Deaths: 0 deaths
SALM/FLUT
Serious events: 19 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QMF149
n=316 participants at risk
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
SALM/FLUT
n=313 participants at risk
SALM/FLUT
|
|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.32%
1/316
|
0.64%
2/313
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.32%
1/316
|
0.00%
0/313
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/316
|
0.32%
1/313
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/316
|
0.32%
1/313
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.32%
1/316
|
0.00%
0/313
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.00%
0/316
|
0.32%
1/313
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.32%
1/316
|
0.00%
0/313
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.32%
1/316
|
0.00%
0/313
|
|
General disorders
MALAISE
|
0.32%
1/316
|
0.00%
0/313
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/316
|
0.32%
1/313
|
|
Infections and infestations
INCISION SITE INFECTION
|
0.32%
1/316
|
0.00%
0/313
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.00%
0/316
|
0.32%
1/313
|
|
Infections and infestations
PNEUMONIA
|
0.63%
2/316
|
0.00%
0/313
|
|
Infections and infestations
SPUTUM PURULENT
|
0.32%
1/316
|
0.00%
0/313
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.32%
1/316
|
0.00%
0/313
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/316
|
0.32%
1/313
|
|
Investigations
ELECTROCARDIOGRAM T WAVE INVERSION
|
0.00%
0/316
|
0.64%
2/313
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.32%
1/316
|
0.00%
0/313
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PLEURAL MESOTHELIOMA MALIGNANT
|
0.00%
0/316
|
0.32%
1/313
|
|
Nervous system disorders
INTRACRANIAL ANEURYSM
|
0.00%
0/316
|
0.32%
1/313
|
|
Nervous system disorders
TEMPORAL LOBE EPILEPSY
|
0.00%
0/316
|
0.32%
1/313
|
|
Nervous system disorders
TENSION HEADACHE
|
0.00%
0/316
|
0.32%
1/313
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/316
|
0.32%
1/313
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/316
|
0.32%
1/313
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
1.9%
6/316
|
1.6%
5/313
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.32%
1/316
|
0.00%
0/313
|
Other adverse events
| Measure |
QMF149
n=316 participants at risk
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
|
SALM/FLUT
n=313 participants at risk
SALM/FLUT
|
|---|---|---|
|
Gastrointestinal disorders
DRY MOUTH
|
1.3%
4/316
|
0.32%
1/313
|
|
Gastrointestinal disorders
NAUSEA
|
1.3%
4/316
|
0.00%
0/313
|
|
General disorders
FATIGUE
|
0.95%
3/316
|
1.3%
4/313
|
|
General disorders
PYREXIA
|
1.9%
6/316
|
0.96%
3/313
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.8%
12/316
|
2.6%
8/313
|
|
Infections and infestations
RHINITIS
|
2.5%
8/316
|
0.64%
2/313
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.3%
4/316
|
1.3%
4/313
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
1.9%
6/316
|
0.64%
2/313
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
1.6%
5/316
|
0.64%
2/313
|
|
Nervous system disorders
DIZZINESS
|
1.3%
4/316
|
0.00%
0/313
|
|
Nervous system disorders
HEADACHE
|
3.2%
10/316
|
1.6%
5/313
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
6.0%
19/316
|
13.7%
43/313
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.8%
9/316
|
1.6%
5/313
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.2%
7/316
|
3.2%
10/313
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
1.9%
6/316
|
0.96%
3/313
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.63%
2/316
|
1.9%
6/313
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER