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
CompletedPhase 3Results postedLast updated 5 March 2020
What this trial tests
Phase 3 trial testing Indacaterol acetate/Mometasone furoate in Asthma in 2,216 participants. Completed in 28 June 2019.
Adults 12 to 75, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26Primary· 26 weeks
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.
Group
Value
95% CI
QMF149 150/320 μg
2.383
± 0.0159
QMF149 150/160 μg
2.387
± 0.0160
MF 800 μg
2.250
± 0.0162
MF 400 μg
2.176
± 0.0162
Salmeterol/Fluticasone 50/500 μg
2.346
± 0.0160
Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52Secondary· Weeks 4, 12, 26 and 52
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
Week 4
Group
Value
95% CI
QMF149 150/320 μg
1.486
± 0.0337
QMF149 150/160 μg
1.533
± 0.0338
MF 800 μg
1.659
± 0.0338
MF 400 μg
1.730
± 0.0337
Salmeterol/Fluticasone 50/500 μg
1.541
± 0.0335
Week 12
Group
Value
95% CI
QMF149 150/320 μg
1.394
± 0.0347
QMF149 150/160 μg
1.377
± 0.0348
MF 800 μg
1.523
± 0.0348
MF 400 μg
1.625
± 0.0350
Salmeterol/Fluticasone 50/500 μg
1.445
± 0.0345
Week 26
Group
Value
95% CI
QMF149 150/320 μg
1.267
± 0.0350
QMF149 150/160 μg
1.261
± 0.0350
MF 800 μg
1.439
± 0.0352
MF 400 μg
1.509
± 0.0354
Salmeterol/Fluticasone 50/500 μg
1.322
± 0.0349
Week 52
Group
Value
95% CI
QMF149 150/320 μg
1.231
± 0.0358
QMF149 150/160 μg
1.183
± 0.0356
MF 800 μg
1.373
± 0.0359
MF 400 μg
1.449
± 0.0361
Salmeterol/Fluticasone 50/500 μg
1.221
± 0.0354
Trough FEV1 at Week 52Secondary· Week 52
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.
Group
Value
95% CI
QMF149 150/320 μg
2.386
± 0.0168
QMF149 150/160 μg
2.357
± 0.0167
MF 800 μg
2.249
± 0.0170
MF 400 μg
2.148
± 0.0170
Salmeterol/Fluticasone 50/500 μg
2.338
± 0.0167
Pre-dose FEV1 at Weeks 4 and 12Secondary· Weeks 4 (Day 30) and 12 (Day 86)
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.
Day 30
Group
Value
95% CI
QMF149 150/320 μg
2.369
± 0.0141
QMF149 150/160 μg
2.367
± 0.0142
MF 800 μg
2.237
± 0.0143
MF 400 μg
2.171
± 0.0143
Salmeterol /Fluticasone 50/500 μg
0.2333
± 0.0141
Day 86
Group
Value
95% CI
QMF149 150/320 μg
2.368
± 0.0148
QMF149 150/160 μg
2.361
± 0.0148
MF 800 μg
2.245
± 0.0148
MF 400 μg
2.177
± 0.0149
Salmeterol /Fluticasone 50/500 μg
2.330
± 0.0146
Post Dose FEV1 (5 Minutes-1 Hour)Secondary· Up to Week 52 (Day 364)
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.
Day 1: 5 minutes
Group
Value
95% CI
QMF149 150/320 μg
2.279
± 0.0084
QMF149 150/160 μg
2.270
± 0.0085
MF 800 μg
2.138
± 0.0085
MF 400 μg
2.118
± 0.0084
Salmeterol/Fluticasone 50/500 μg
2.224
± 0.0084
Day 1: 15 minutes
Group
Value
95% CI
QMF149 150/320 μg
2.321
± 0.0088
QMF149 150/160 μg
2.312
± 0.0089
MF 800 μg
2.159
± 0.0089
MF 400 μg
2.137
± 0.0089
Salmeterol/Fluticasone 50/500 μg
2.278
± 0.0088
Day 1: 30 minutes
Group
Value
95% CI
QMF149 150/320 μg
2.338
± 0.0095
QMF149 150/160 μg
2.326
± 0.0096
MF 800 μg
2.162
± 0.0096
MF 400 μg
2.141
± 0.0095
Salmeterol/Fluticasone 50/500 μg
2.310
± 0.0095
Day 1: 1 hour
Group
Value
95% CI
QMF149 150/320 μg
2.343
± 0.0100
QMF149 150/160 μg
2.347
± 0.0101
MF 800 μg
2.166
± 0.0101
MF 400 μg
2.142
± 0.0100
Salmeterol/Fluticasone 50/500 μg
2.337
± 0.0100
Day 30: 5 minutes
Group
Value
95% CI
QMF149 150/320 μg
2.413
± 0.0142
QMF149 150/160 μg
2.406
± 0.0144
MF 800 μg
2.224
± 0.0145
MF 400 μg
2.174
± 0.0145
Salmeterol/Fluticasone 50/500 μg
2.360
± 0.0142
Day 30: 30 minutes
Group
Value
95% CI
QMF149 150/320 μg
2.432
± 0.0143
QMF149 150/160 μg
2.426
± 0.0145
MF 800 μg
2.238
± 0.0146
MF 400 μg
2.174
± 0.0146
Salmeterol/Fluticasone 50/500 μg
2.389
± 0.0143
Day 30: 1 hour
Group
Value
95% CI
QMF149 150/320 μg
2.448
± 0.0145
QMF149 150/160 μg
2.440
± 0.0146
MF 800 μg
2.257
± 0.0147
MF 400 μg
2.183
± 0.0148
Salmeterol/Fluticasone 50/500 μg
2.411
± 0.0144
Day 86:5 minutes
Group
Value
95% CI
QMF149 150/320 μg
2.411
± 0.0150
QMF149 150/160 μg
2.409
± 0.0150
MF 800 μg
2.248
± 0.0150
MF 400 μg
2.178
± 0.0153
Salmeterol/Fluticasone 50/500 μg
2.356
± 0.0148
Trough Forced Vital Capacity (FVC)Secondary· Up to Week 52 (Day 365)
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.
Day 2
Group
Value
95% CI
QMF149 150/320 μg
3.342
± 0.0173
QMF149 150/160 μg
3.342
± 0.0174
MF 800 μg
3.256
± 0.0177
MF 400 μg
3.203
± 0.0173
Salmeterol/Fluticasone 50/500 μg
3.344
± 0.0176
Day 184
Group
Value
95% CI
QMF149 150/320 μg
3.372
± 0.0179
QMF149 150/160 μg
3.387
± 0.0180
MF 800 μg
3.322
± 0.0183
MF 400 μg
3.246
± 0.0182
Salmeterol/Fluticasone 50/500 μg
3.355
± 0.0180
Day 365
Group
Value
95% CI
QMF149 150/320 μg
3.394
± 0.0182
QMF149 150/160 μg
3.364
± 0.0181
MF 800 μg
3.319
± 0.0184
MF 400 μg
3.218
± 0.0183
Salmeterol/Fluticasone 50/500 μg
3.358
± 0.0182
Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)Secondary· Up to Week 52 (Day 365)
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.
Day 2
Group
Value
95% CI
QMF149 150/320 μg
1.644
± 0.0186
QMF149 150/160 μg
1.617
± 0.0187
MF 800 μg
1.455
± 0.0191
MF 400 μg
1.406
± 0.0186
Salmeterol/Fluticasone 50/500 μg
1.662
± 0.0189
Day 184
Group
Value
95% CI
QMF149 150/320 μg
1.775
± 0.0249
QMF149 150/160 μg
1.738
± 0.0250
MF 800 μg
1.546
± 0.0253
MF 400 μg
1.473
± 0.0254
Salmeterol/Fluticasone 50/500 μg
1.692
± 0.0250
Day 365
Group
Value
95% CI
QMF149 150/320 μg
1.745
± 0.0259
QMF149 150/160 μg
1.686
± 0.0257
MF 800 μg
1.530
± 0.0261
MF 400 μg
1.440
± 0.0261
Salmeterol/Fluticasone 50/500 μg
1.692
± 0.0258
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of TreatmentSecondary· Up to Weeks 26 and 52
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.
Week 26: Mean morning PEF
Group
Value
95% CI
QMF149 150/320 μg
42.4
± 2.15
QMF149 150/160 μg
38.1
± 2.15
MF 800 μg
12.8
± 2.13
MF 400 μg
5.9
± 2.14
Salmeterol/Fluticasone 50/500 μg
29.1
± 2.14
Week 26:Mean evening PEF
Group
Value
95% CI
QMF149 150/320 μg
32.5
± 2.05
QMF149 150/160 μg
30.4
± 2.04
MF 800 μg
7.7
± 2.04
MF 400 μg
0.0
± 2.05
Salmeterol/Fluticasone 50/500 μg
23.9
± 2.04
Week 52:Mean morning PEF
Group
Value
95% CI
QMF149 150/320 μg
42.1
± 2.24
QMF149 150/160 μg
36.9
± 2.22
MF 800 μg
13.4
± 2.21
MF 400 μg
6.7
± 2.22
Salmeterol/Fluticasone 50/500 μg
28.3
± 2.22
Week 52:Mean evening PEF
Group
Value
95% CI
QMF149 150/320 μg
31.2
± 2.14
QMF149 150/160 μg
28.7
± 2.13
MF 800 μg
7.4
± 2.13
MF 400 μg
-0.3
± 2.14
Salmeterol/Fluticasone 50/500 μg
22.1
± 2.13
Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52Secondary· Weeks 26 (Day 183) and 52 (Day 364)
Change from baseline in ACQ-7 scores of ≤ 0.5 was defined as minimal clinically important difference and were considered clinically meaningful. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored
Day 183
Group
Value
95% CI
QMF149 150/320 μg
76.4
QMF149 150/160 μg
76.2
MF 800 μg
72.3
MF 400 μg
66.9
Salmeterol/Fluticasone 50/500 μg
75.9
Day 364
Group
Value
95% CI
QMF149 150/320 μg
77.7
QMF149 150/160 μg
82.1
MF 800 μg
73.6
MF 400 μg
69.2
Salmeterol/Fluticasone 50/500 μg
77.3
Change From Baseline in Percentage of Asthma Symptoms Free DaysSecondary· Up to Week 52
All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. Asthma symptoms free days are days with no daytime symptoms, no night-time awakenings and no symptoms on awakening. The daytime asthma symptom score was based on the daily e-diary recordings by participants with respect to shortness of breath, wheeze, cough, chest tightness, and impact on
Group
Value
95% CI
QMF149 150/320 μg
28.3
± 1.72
QMF149 150/160 μg
28.4
± 1.72
MF 800 μg
22.5
± 1.72
MF 400 μg
19.3
± 1.72
Salmeterol/Fluticasone 50/500 μg
24.9
± 1.72
Change Form Baseline in Percentage of Days With no Daytime SymptomsSecondary· Up to Week 52
All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. For days with no daytime symptoms, all 5 evening questions must have a score = 0 with respect to shortness of breath, wheeze, cough, chest tightness and impact on usual daily activities due to symptoms, each with scores from 0 (no problems) to 4 (very severe problems).
Group
Value
95% CI
QMF149 150/320 μg
28.0
± 1.69
QMF149 150/160 μg
28.0
± 1.69
MF 800 μg
23.0
± 1.68
MF 400 μg
20.0
± 1.69
Salmeterol/Fluticasone 50/500 μg
24.8
± 1.68
Change From Baseline in Percentage of Nights With no Night-time AwakeningsSecondary· Up to Week 52
All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was "How did you sleep last night?" had to be answered with "I did not wake up because of any breathing problems" with scores from 0 (no problem)-4 (very severe problems).
Group
Value
95% CI
QMF149 150/320 μg
17.0
± 1.28
QMF149 150/160 μg
16.4
± 1.27
MF 800 μg
14.2
± 1.27
MF 400 μg
12.5
± 1.27
Salmeterol/Fluticasone 50/500 μg
16.1
± 1.27
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious adverse events: From first dose up to 30 days post last dose (approximately 56 weeks) Other adverse events: From first dose up to 7 days post last dose (approximately 53 weeks).
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary function testing, and effects on asthma control
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 5 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02554786.