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A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma

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ClinicalTrials.gov Identifier: NCT02554786
Recruitment Status : Completed
First Posted : September 18, 2015
Results First Posted : March 5, 2020
Last Update Posted : March 5, 2020
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 Asthma
Interventions Drug: Indacaterol acetate/Mometasone furoate
Drug: Mometasone furoate
Drug: Salmeterol xinafoate/fluticasone propionate
Enrollment 2216
Recruitment Details Participants took part in 316 investigative sites in 24 countries from 29 Dec 2015 to 28 Jun 2019.
Pre-assignment Details 3890 participants were screened of which 2216 were randomized to 1 of the 5 treatment groups with a randomization ratio of 1:1:1:1:1.
Arm/Group Title QMF149 150/320 μg QMF149 150/160 μg MF 800 μg MF 400 μg Salmeterol/Fluticasone 50/500 μg
Hide Arm/Group Description QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered once daily (o.d.) via Concept1 inhaler in the evening. QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening. Mometasone furoate (MF) 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®. MF 400 μg was delivered o.d. via Twisthaler® in the evening. Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
Period Title: Overall Study
Started 445 439 442 444 446
Completed 410 413 412 403 416
Not Completed 35 26 30 41 30
Reason Not Completed
Subject/guardian decision             29             17             18             30             20
Lost to Follow-up             4             3             4             2             2
Protocol deviation             1             3             3             4             2
Technical problems             1             1             0             2             1
Adverse Event             0             0             0             0             2
Death             0             0             0             1             0
Non-compliance with study treatment             0             1             1             0             1
Physician Decision             0             1             4             1             1
Pregnancy             0             0             0             1             1
Arm/Group Title QMF149 150/320 μg QMF149 150/160 μg MF 800 μg MF 400 μg Salmeterol/Fluticasone 50/500 μg Total
Hide Arm/Group Description QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening. QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening. MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®. MF 400 μg was delivered o.d. via Twisthaler® in the evening. Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®. Total of all reporting groups
Overall Number of Baseline Participants 445 439 442 444 446 2216
Hide Baseline Analysis Population Description
Randomized Set (RAN) consisted of all participants who were assigned a randomization number, regardless of whether or not they actually received study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 445 participants 439 participants 442 participants 444 participants 446 participants 2216 participants
47.1  (14.56) 47.4  (14.76) 47.5  (14.99) 48.7  (14.98) 48.9  (14.59) 47.9  (14.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 445 participants 439 participants 442 participants 444 participants 446 participants 2216 participants
Female
262
  58.9%
253
  57.6%
250
  56.6%
272
  61.3%
256
  57.4%
1293
  58.3%
Male
183
  41.1%
186
  42.4%
192
  43.4%
172
  38.7%
190
  42.6%
923
  41.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 445 participants 439 participants 442 participants 444 participants 446 participants 2216 participants
Caucasian
313
  70.3%
311
  70.8%
318
  71.9%
312
  70.3%
305
  68.4%
1559
  70.4%
Black
5
   1.1%
2
   0.5%
4
   0.9%
8
   1.8%
4
   0.9%
23
   1.0%
Asian
97
  21.8%
98
  22.3%
98
  22.2%
98
  22.1%
102
  22.9%
493
  22.2%
Native American
13
   2.9%
14
   3.2%
11
   2.5%
18
   4.1%
12
   2.7%
68
   3.1%
Pacific Islander
1
   0.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.0%
Other
16
   3.6%
14
   3.2%
11
   2.5%
8
   1.8%
23
   5.2%
72
   3.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 445 participants 439 participants 442 participants 444 participants 446 participants 2216 participants
Hispanic Or Latino
21
   4.7%
17
   3.9%
14
   3.2%
22
   5.0%
15
   3.4%
89
   4.0%
East Asian
52
  11.7%
48
  10.9%
51
  11.5%
55
  12.4%
53
  11.9%
259
  11.7%
Southeast Asian
38
   8.5%
40
   9.1%
42
   9.5%
38
   8.6%
42
   9.4%
200
   9.0%
South Asian
3
   0.7%
3
   0.7%
2
   0.5%
3
   0.7%
3
   0.7%
14
   0.6%
Russian
79
  17.8%
79
  18.0%
64
  14.5%
62
  14.0%
65
  14.6%
349
  15.7%
Mixed ethnicity
10
   2.2%
10
   2.3%
9
   2.0%
5
   1.1%
15
   3.4%
49
   2.2%
Not reported
12
   2.7%
4
   0.9%
12
   2.7%
5
   1.1%
9
   2.0%
42
   1.9%
Unknown
12
   2.7%
13
   3.0%
6
   1.4%
15
   3.4%
17
   3.8%
63
   2.8%
Other
218
  49.0%
225
  51.3%
242
  54.8%
239
  53.8%
227
  50.9%
1151
  51.9%
1.Primary Outcome
Title Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26
Hide Description Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all participants in the RAN set who received at least one dose of study medication.
Arm/Group Title QMF149 150/320 μg QMF149 150/160 μg MF 800 μg MF 400 μg Salmeterol/Fluticasone 50/500 μg
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
Overall Number of Participants Analyzed 395 389 372 376 391
Least Squares Mean (Standard Error)
Unit of Measure: litre (L)
2.383  (0.0159) 2.387  (0.0160) 2.250  (0.0162) 2.176  (0.0162) 2.346  (0.0160)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Model for Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square mean (LS Mean)
Estimated Value 0.132
Confidence Interval (2-Sided) 95%
0.088 to 0.176
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0223
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.211
Confidence Interval (2-Sided) 95%
0.167 to 0.255
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0224
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52
Hide Description The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions.
Time Frame Weeks 4, 12, 26 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit
Arm/Group Title QMF149 150/320 μg QMF149 150/160 μg MF 800 μg MF 400 μg Salmeterol/Fluticasone 50/500 μg
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
Overall Number of Participants Analyzed 429 427 431 428 439
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Week 4 Number Analyzed 426 participants 422 participants 429 participants 425 participants 437 participants
1.486  (0.0337) 1.533  (0.0338) 1.659  (0.0338) 1.730  (0.0337) 1.541  (0.0335)
Week 12 Number Analyzed 419 participants 414 participants 422 participants 407 participants 429 participants
1.394  (0.0347) 1.377  (0.0348) 1.523  (0.0348) 1.625  (0.0350) 1.445  (0.0345)
Week 26 Number Analyzed 407 participants 407 participants 405 participants 393 participants 410 participants
1.267  (0.0350) 1.261  (0.0350) 1.439  (0.0352) 1.509  (0.0354) 1.322  (0.0349)
Week 52 Number Analyzed 385 participants 397 participants 387 participants 377 participants 405 participants
1.231  (0.0358) 1.183  (0.0356) 1.373  (0.0359) 1.449  (0.0361) 1.221  (0.0354)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.172
Confidence Interval (2-Sided) 95%
-0.254 to -0.091
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0415
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.196
Confidence Interval (2-Sided) 95%
-0.278 to -0.115
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0416
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.186
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.055
Confidence Interval (2-Sided) 95%
-0.136 to 0.026
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0414
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, QMF149 150/160 μg, MF 800 μg, MF 400 μg
Comments Week 4: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 & 150/320 μg and MF 400 & 800 μg derived by weighting treatment groups equally.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.184
Confidence Interval (2-Sided) 95%
-0.242 to -0.127
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0294
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.129
Confidence Interval (2-Sided) 95%
-0.214 to -0.044
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0431
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.248
Confidence Interval (2-Sided) 95%
-0.333 to -0.162
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0435
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.232
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.052
Confidence Interval (2-Sided) 95%
-0.136 to 0.033
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0431
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, QMF149 150/160 μg, MF 800 μg, MF 400 μg
Comments Week 12: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 & 150/320 μg and MF 400 & 800 μg derived by weighting treatment groups equally.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.188
Confidence Interval (2-Sided) 95%
-0.248 to -0.128
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0307
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.171
Confidence Interval (2-Sided) 95%
-0.257 to -0.086
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0437
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.248
Confidence Interval (2-Sided) 95%
-0.334 to -0.162
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0439
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Week 26
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.054
Confidence Interval (2-Sided) 95%
-0.140 to 0.031
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0437
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, QMF149 150/160 μg, MF 800 μg, MF 400 μg
Comments Week 26: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 & 150/320 μg and MF 400 & 800 μg derived by weighting treatment groups equally.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.209
Confidence Interval (2-Sided) 95%
-0.270 to -0.149
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0310
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.141
Confidence Interval (2-Sided) 95%
-0.229 to -0.053
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0449
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.266
Confidence Interval (2-Sided) 95%
-0.354 to -0.177
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.045
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.824
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.078 to 0.098
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0447
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, QMF149 150/160 μg, MF 800 μg, MF 400 μg
Comments Week 52: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 & 150/320 μg and MF 400 & 800 μg derived by weighting treatment groups equally.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.203
Confidence Interval (2-Sided) 95%
-0.266 to -0.141
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0318
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Trough FEV1 at Week 52
Hide Description Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the RAN set who received at least one dose of study medication.
Arm/Group Title QMF149 150/320 μg QMF149 150/160 μg MF 800 μg MF 400 μg Salmeterol/Fluticasone 50/500 μg
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
Overall Number of Participants Analyzed 372 383 364 369 382
Least Squares Mean (Standard Error)
Unit of Measure: L
2.386  (0.0168) 2.357  (0.0167) 2.249  (0.0170) 2.148  (0.0170) 2.338  (0.0167)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.136
Confidence Interval (2-Sided) 95%
0.090 to 0.183
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0235
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.209
Confidence Interval (2-Sided) 95%
0.163 to 0.255
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0235
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.048
Confidence Interval (2-Sided) 95%
0.002 to 0.094
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0234
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Pre-dose FEV1 at Weeks 4 and 12
Hide Description Pre-dose trough FEV1 is defined as average of the two FEV1 measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Time Frame Weeks 4 (Day 30) and 12 (Day 86)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit.
Arm/Group Title QMF149 150/320 μg QMF149 150/160 μg MF 800 μg MF 400 μg Salmeterol /Fluticasone 50/500 μg
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
MF 400 μg was delivered o.d via Twisthaler® in the evening
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
Overall Number of Participants Analyzed 430 427 430 427 439
Least Squares Mean (Standard Deviation)
Unit of Measure: L
Day 30 Number Analyzed 430 participants 424 participants 421 participants 412 participants 435 participants
2.369  (0.0141) 2.367  (0.0142) 2.237  (0.0143) 2.171  (0.0143) 0.2333  (0.0141)
Day 86 Number Analyzed 414 participants 414 participants 419 participants 398 participants 428 participants
2.368  (0.0148) 2.361  (0.0148) 2.245  (0.0148) 2.177  (0.0149) 2.330  (0.0146)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 30
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.132
Confidence Interval (2-Sided) 95%
0.094 to 0.170
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0193
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 30
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.196
Confidence Interval (2-Sided) 95%
0.158 to 0.234
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0194
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol /Fluticasone 50/500 μg
Comments Day 30
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.035
Confidence Interval (2-Sided) 95%
-0.002 to 0.073
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0192
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 86
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.122
Confidence Interval (2-Sided) 95%
0.083 to 0.162
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0201
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 86
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.184
Confidence Interval (2-Sided) 95%
0.144 to 0.224
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0202
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol /Fluticasone 50/500 μg
Comments Day 86
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.037
Confidence Interval (2-Sided) 95%
-0.002 to 0.076
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Post Dose FEV1 (5 Minutes-1 Hour)
Hide Description Post-dose FEV1 measurements were analyzed at 5 minutes, 15 minutes, 30 minutes and 1 hour. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Time Frame Up to Week 52 (Day 364)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective time point.
Arm/Group Title QMF149 150/320 μg QMF149 150/160 μg MF 800 μg MF 400 μg Salmeterol/Fluticasone 50/500 μg
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
Overall Number of Participants Analyzed 441 434 438 438 442
Least Squares Mean (Standard Error)
Unit of Measure: L
Day 1: 5 minutes Number Analyzed 427 participants 426 participants 429 participants 432 participants 435 participants
2.279  (0.0084) 2.270  (0.0085) 2.138  (0.0085) 2.118  (0.0084) 2.224  (0.0084)
Day 1: 15 minutes Number Analyzed 434 participants 425 participants 433 participants 433 participants 441 participants
2.321  (0.0088) 2.312  (0.0089) 2.159  (0.0089) 2.137  (0.0089) 2.278  (0.0088)
Day 1: 30 minutes Number Analyzed 439 participants 431 participants 434 participants 438 participants 441 participants
2.338  (0.0095) 2.326  (0.0096) 2.162  (0.0096) 2.141  (0.0095) 2.310  (0.0095)
Day 1: 1 hour Number Analyzed 440 participants 434 participants 435 participants 438 participants 442 participants
2.343  (0.0100) 2.347  (0.0101) 2.166  (0.0101) 2.142  (0.0100) 2.337  (0.0100)
Day 30: 5 minutes Number Analyzed 428 participants 420 participants 419 participants 411 participants 435 participants
2.413  (0.0142) 2.406  (0.0144) 2.224  (0.0145) 2.174  (0.0145) 2.360  (0.0142)
Day 30: 30 minutes Number Analyzed 429 participants 420 participants 421 participants 412 participants 435 participants
2.432  (0.0143) 2.426  (0.0145) 2.238  (0.0146) 2.174  (0.0146) 2.389  (0.0143)
Day 30: 1 hour Number Analyzed 428 participants 416 participants 421 participants 410 participants 435 participants
2.448  (0.0145) 2.440  (0.0146) 2.257  (0.0147) 2.183  (0.0148) 2.411  (0.0144)
Day 86:5 minutes Number Analyzed 411 participants 411 participants 416 participants 395 participants 427 participants
2.411  (0.0150) 2.409  (0.0150) 2.248  (0.0150) 2.178  (0.0153) 2.356  (0.0148)
Day 86: 30 minutes Number Analyzed 412 participants 411 participants 417 participants 395 participants 426 participants
2.436  (0.0149) 2.431  (0.0149) 2.257  (0.0149) 2.179  (0.0152) 2.398  (0.0147)
Day 86:1 hour Number Analyzed 412 participants 410 participants 417 participants 396 participants 426 participants
2.456  (0.0151) 2.436  (0.0151) 2.269  (0.0151) 2.188  (0.0154) 2.413  (0.0149)
Day 183: 5 minutes Number Analyzed 404 participants 399 participants 400 participants 385 participants 409 participants
2.403  (0.0160) 2.406  (0.0161) 2.240  (0.0162) 2.163  (0.0164) 2.359  (0.0160)
Day 183: 30 minutes Number Analyzed 405 participants 401 participants 399 participants 383 participants 407 participants
2.426  (0.0163) 2.427  (0.0164) 2.250  (0.0165) 2.168  (0.0167) 2.386  (0.0163)
Day 183: 1 hour Number Analyzed 405 participants 400 participants 397 participants 385 participants 409 participants
2.432  (0.0161) 2.423  (0.0162) 2.253  (0.0163) 2.165  (0.0165) 2.393  (0.0161)
Day 364: 5 minutes Number Analyzed 375 participants 389 participants 380 participants 374 participants 403 participants
2.384  (0.0172) 2.379  (0.0169) 2.245  (0.0172) 2.130  (0.0173) 2.358  (0.0168)
Day 364: 30 minutes Number Analyzed 377 participants 393 participants 379 participants 373 participants 401 participants
2.408  (0.0171) 2.399  (0.0169) 2.253  (0.0172) 2.135  (0.0172) 2.377  (0.0167)
Day 364:1 hour Number Analyzed 378 participants 393 participants 379 participants 375 participants 402 participants
2.414  (0.0175) 2.390  (0.0172) 2.251  (0.0175) 2.128  (0.0176) 2.383  (0.0171)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 1: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.142
Confidence Interval (2-Sided) 95%
0.119 to 0.164
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0116
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 1: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.152
Confidence Interval (2-Sided) 95%
0.129 to 0.175
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0116
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 1: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.055
Confidence Interval (2-Sided) 95%
0.032 to 0.078
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0116
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 1: 15 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.162
Confidence Interval (2-Sided) 95%
0.138 to 0.186
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0122
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 1: 15 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean
Estimated Value 0.174
Confidence Interval (2-Sided) 95%
0.150 to 0.198
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0123
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day1: 15 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.044
Confidence Interval (2-Sided) 95%
0.02 to 0.068
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0122
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 1: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.175
Confidence Interval (2-Sided) 95%
0.149 to 0.201
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0132
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 1: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.185
Confidence Interval (2-Sided) 95%
0.159 to 0.211
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0132
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 1: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.027
Confidence Interval (2-Sided) 95%
0.001 to 0.053
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0132
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 1: 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.178
Confidence Interval (2-Sided) 95%
0.150 to 0.205
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0139
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 1: 1hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.205
Confidence Interval (2-Sided) 95%
0.177 to 0.232
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0139
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 1: 1hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.632
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.007
Confidence Interval (2-Sided) 95%
-0.021 to 0.034
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0139
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 30: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.189
Confidence Interval (2-Sided) 95%
0.151 to 0.226
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0192
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 30: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.232
Confidence Interval (2-Sided) 95%
0.194 to 0.270
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0194
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 30: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.053
Confidence Interval (2-Sided) 95%
0.016 to 0.091
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0191
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 30: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.194
Confidence Interval (2-Sided) 95%
0.156 to 0.232
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0194
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 30: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.253
Confidence Interval (2-Sided) 95%
0.214 to 0.291
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0196
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 30: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.043
Confidence Interval (2-Sided) 95%
0.005 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0192
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 30: 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.190
Confidence Interval (2-Sided) 95%
0.152 to 0.229
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0196
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 30: 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.258
Confidence Interval (2-Sided) 95%
0.219 to 0.296
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0198
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 30: 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.037
Confidence Interval (2-Sided) 95%
-0.001 to 0.075
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0194
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 86: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.163
Confidence Interval (2-Sided) 95%
0.123 to 0.203
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0204
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 86: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.231
Confidence Interval (2-Sided) 95%
0.191 to 0.271
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0206
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 86: 5minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.055
Confidence Interval (2-Sided) 95%
0.015 to 0.095
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0203
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 86: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.180
Confidence Interval (2-Sided) 95%
0.140 to 0.219
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0203
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 86: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.252
Confidence Interval (2-Sided) 95%
0.211 to 0.292
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0205
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 86: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.038
Confidence Interval (2-Sided) 95%
-0.001 to 0.078
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0202
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 86: 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.187
Confidence Interval (2-Sided) 95%
0.147 to 0.227
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0205
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 86: 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.249
Confidence Interval (2-Sided) 95%
0.208 to 0.289
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0208
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 86: 1hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.043
Confidence Interval (2-Sided) 95%
0.003 to 0.083
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0205
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 183: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.163
Confidence Interval (2-Sided) 95%
0.121 to 0.206
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0217
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 183: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.243
Confidence Interval (2-Sided) 95%
0.200 to 0.286
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0219
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 183: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.044
Confidence Interval (2-Sided) 95%
0.002 to 0.087
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0216
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 183: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.176
Confidence Interval (2-Sided) 95%
0.133 to 0.220
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0222
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 183: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.259
Confidence Interval (2-Sided) 95%
0.215 to 0.303
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0224
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 183: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.003 to 0.083
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0221
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 183: 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.180
Confidence Interval (2-Sided) 95%
0.137 to 0.223
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0219
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 183: 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.259
Confidence Interval (2-Sided) 95%
0.215 to 0.302
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0222
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 183: 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.039
Confidence Interval (2-Sided) 95%
-0.003 to 0.082
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0218
Estimation Comments [Not Specified]
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 364: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.139
Confidence Interval (2-Sided) 95%
0.094 to 0.184
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0229
Estimation Comments [Not Specified]
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 364: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.249
Confidence Interval (2-Sided) 95%
0.205 to 0.294
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0228
Estimation Comments [Not Specified]
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 364: 5 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.244
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.026
Confidence Interval (2-Sided) 95%
-0.018 to 0.071
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0227
Estimation Comments [Not Specified]
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 364: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.155
Confidence Interval (2-Sided) 95%
0.110 to 0.200
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0228
Estimation Comments [Not Specified]
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 364: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.264
Confidence Interval (2-Sided) 95%
0.219 to 0.308
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0227
Estimation Comments [Not Specified]
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 364: 30 minutes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.162
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.032
Confidence Interval (2-Sided) 95%
-0.013 to 0.076
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0226
Estimation Comments [Not Specified]
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 364: 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.163
Confidence Interval (2-Sided) 95%
0.117 to 0.209
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0234
Estimation Comments [Not Specified]
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 364: 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.262
Confidence Interval (2-Sided) 95%
0.216 to 0.308
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0232
Estimation Comments [Not Specified]
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 364: 1 hour
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.182
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.031
Confidence Interval (2-Sided) 95%
-0.014 to 0.076
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0231
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Trough Forced Vital Capacity (FVC)
Hide Description FVC is the total amount of air exhaled during the FEV test. Trough FVC is defined as average of the two FVC measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.
Time Frame Up to Week 52 (Day 365)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit.
Arm/Group Title QMF149 150/320 μg QMF149 150/160 μg MF 800 μg MF 400 μg Salmeterol/Fluticasone 50/500 μg
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
Overall Number of Participants Analyzed 439 433 436 441 441
Least Squares Mean (Standard Error)
Unit of Measure: L
Day 2 Number Analyzed 432 participants 430 participants 410 participants 435 participants 419 participants
3.342  (0.0173) 3.342  (0.0174) 3.256  (0.0177) 3.203  (0.0173) 3.344  (0.0176)
Day 184 Number Analyzed 395 participants 389 participants 372 participants 376 participants 391 participants
3.372  (0.0179) 3.387  (0.0180) 3.322  (0.0183) 3.246  (0.0182) 3.355  (0.0180)
Day 365 Number Analyzed 372 participants 383 participants 365 participants 369 participants 382 participants
3.394  (0.0182) 3.364  (0.0181) 3.319  (0.0184) 3.218  (0.0183) 3.358  (0.0182)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.086
Confidence Interval (2-Sided) 95%
0.040 to 0.133
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0237
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.139
Confidence Interval (2-Sided) 95%
0.093 to 0.185
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0235
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.927
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.002
Confidence Interval (2-Sided) 95%
-0.049 to 0.044
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0237
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 184
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.050
Confidence Interval (2-Sided) 95%
0.001 to 0.098
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0246
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 184
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.141
Confidence Interval (2-Sided) 95%
0.093 to 0.190
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0246
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 184
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.490
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.017
Confidence Interval (2-Sided) 95%
-0.031 to 0.065
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0244
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 365
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.076
Confidence Interval (2-Sided) 95%
0.027 to 0.125
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0249
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 365
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.146
Confidence Interval (2-Sided) 95%
0.098 to 0.195
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0248
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 365
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.036
Confidence Interval (2-Sided) 95%
-0.012 to 0.085
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0248
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)
Hide Description FEF is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Trough FEF25-75% is defined as average of the two FEF25-75% measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.
Time Frame Up to Week 52 (Day 365)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit.
Arm/Group Title QMF149 150/320 μg QMF149 150/160 μg MF 800 μg MF 400 μg Salmeterol/Fluticasone 50/500 μg
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
Overall Number of Participants Analyzed 439 433 436 441 441
Least Squares Mean (Standard Error)
Unit of Measure: Litres/second (L/s)
Day 2 Number Analyzed 432 participants 430 participants 410 participants 435 participants 419 participants
1.644  (0.0186) 1.617  (0.0187) 1.455  (0.0191) 1.406  (0.0186) 1.662  (0.0189)
Day 184 Number Analyzed 395 participants 389 participants 372 participants 376 participants 391 participants
1.775  (0.0249) 1.738  (0.0250) 1.546  (0.0253) 1.473  (0.0254) 1.692  (0.0250)
Day 365 Number Analyzed 372 participants 383 participants 365 participants 369 participants 382 participants
1.745  (0.0259) 1.686  (0.0257) 1.530  (0.0261) 1.440  (0.0261) 1.692  (0.0258)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.189
Confidence Interval (2-Sided) 95%
0.139 to 0.238
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0253
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.210
Confidence Interval (2-Sided) 95%
0.161 to 0.259
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.025
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.475
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -0.018
Confidence Interval (2-Sided) 95%
-0.067 to 0.031
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0252
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 184
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.228
Confidence Interval (2-Sided) 95%
0.161 to 0.296
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0345
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 184
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.265
Confidence Interval (2-Sided) 95%
0.197 to 0.333
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0346
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 184
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.083
Confidence Interval (2-Sided) 95%
0.016 to 0.151
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0343
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Day 365
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.215
Confidence Interval (2-Sided) 95%
0.145 to 0.285
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0358
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Day 365
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.246
Confidence Interval (2-Sided) 95%
0.176 to 0.316
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0357
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Day 365
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.139
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 0.053
Confidence Interval (2-Sided) 95%
-0.017 to 0.122
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0356
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
Hide Description PEF is a person's maximum speed of expiration. All the participants were instructed to record PEF twice daily using a mini Peak Flow Meter device, once in the morning (before taking the morning dose) and once approximately 12 h later in the evening (before taking the evening dose). At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the e-PEF/diary. The best of 3 values were used.
Time Frame Up to Weeks 26 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study medication. n represents tthe number of participants with data at respective visit.
Arm/Group Title QMF149 150/320 μg QMF149 150/160 μg MF 800 μg MF 400 μg Salmeterol/Fluticasone 50/500 μg
Hide Arm/Group Description:
QMF149 (Indacaterol acetate/Mometasone furoate) 150/320 μg was delivered o.d. via Concept1 inhaler in the evening.
QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 μg was delivered o.d. via Concept1 inhaler in the evening.
MF 800 μg of total daily dose (400 μg twice daily, in the morning and in the evening) was delivered via Twisthaler®.
MF 400 μg was delivered o.d. via Twisthaler® in the evening.
Salmeterol xinafoate/fluticasone propionate 50/500 μg was delivered twice daily (in the morning and in the evening) via Accuhaler®.
Overall Number of Participants Analyzed 443 437 440 443 444
Least Squares Mean (Standard Error)
Unit of Measure: L/min
Week 26: Mean morning PEF Number Analyzed 418 participants 419 participants 430 participants 422 participants 426 participants
42.4  (2.15) 38.1  (2.15) 12.8  (2.13) 5.9  (2.14) 29.1  (2.14)
Week 26:Mean evening PEF Number Analyzed 417 participants 420 participants 425 participants 419 participants 423 participants
32.5  (2.05) 30.4  (2.04) 7.7  (2.04) 0.0  (2.05) 23.9  (2.04)
Week 52:Mean morning PEF Number Analyzed 415 participants 420 participants 427 participants 422 participants 424 participants
42.1  (2.24) 36.9  (2.22) 13.4  (2.21) 6.7  (2.22) 28.3  (2.22)
Week 52:Mean evening PEF Number Analyzed 416 participants 420 participants 424 participants 418 participants 422 participants
31.2  (2.14) 28.7  (2.13) 7.4  (2.13) -0.3  (2.14) 22.1  (2.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Week 26: Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Linear Mixed Model (LMM)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 29.6
Confidence Interval (2-Sided) 95%
23.8 to 35.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Week 26: Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 32.2
Confidence Interval (2-Sided) 95%
26.4 to 38.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Week 26: Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 13.3
Confidence Interval (2-Sided) 95%
7.5 to 19.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Week 26: Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 24.8
Confidence Interval (2-Sided) 95%
19.3 to 30.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Week 26: Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 30.4
Confidence Interval (2-Sided) 95%
24.8 to 35.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Week 26: Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 8.6
Confidence Interval (2-Sided) 95%
3.1 to 14.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Week 52: Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 28.7
Confidence Interval (2-Sided) 95%
22.7 to 34.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Week 52: Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 30.2
Confidence Interval (2-Sided) 95%
24.2 to 36.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Week 52: Mean morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 13.8
Confidence Interval (2-Sided) 95%
7.7 to 19.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, MF 800 μg
Comments Week 52: Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 23.7
Confidence Interval (2-Sided) 95%
18.0 to 29.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection QMF149 150/160 μg, MF 400 μg
Comments Week 52: Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 29.1
Confidence Interval (2-Sided) 95%
23.3 to 34.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection QMF149 150/320 μg, Salmeterol/Fluticasone 50/500 μg
Comments Week 52: Mean evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method LMM
Comments [Not Specified]
Method of Estimation Estimation Parameter