Phase 2
Completed N=629
Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01636076 ↗Enrolled (actual)
629
Serious AEs
4.6%
Results posted
Nov 2014
Primary outcomePrimary: Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85 — 1.270; 1.215; 1.277; 1.228 Liters
Summary
To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with COPD
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85 |
1.270; 1.215; 1.277; 1.228 | — |
| SECONDARY Trough FEV1 After First Dose and After 4 Weeks of Treatment |
1.147; 1.167; 1.216; 1.243; 1.148; 1.178 | — |
| SECONDARY Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint |
1.254; 1.198; 1.281; 1.250; 1.281; 1.256 | — |
| SECONDARY Forced Vital Capacity (FVC) at Each Timepoint |
2.460; 2.481; 0.179; 0.060; 0.207; 0.129 | — |
| SECONDARY FEV1/FVC at Each Timepoint |
46.786; 46.859; 0.488; 0.047; 0.955; 0.879 | — |
| SECONDARY FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min - 4h) |
1.142; 1.169; 1.277; 1.260 | — |
| SECONDARY FEV1 AUC (5 Min-4 h), |
1.302; 1.331; 1.410; 1.355; 1.387; 1.372 | — |
| SECONDARY Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for AUC (5 Min - 23 h 45 Min) for FEV1 (L) on Day 28 and Day 84 (Full Analysis Set, 24-h Profiling Subgroup) |
1.352; 1.298; 1.317; 1.303 | — |
| SECONDARY The Usage of Rescue Medication (Short Acting β2-agonist) |
-1.064; -0.593; -0.625; -0.300; -0.452; -0.308 | — |
| SECONDARY The Overall Change in Usage of Rescue Medication (Short Acting β2-agonist) . |
8.796; 2.538 | — |
| SECONDARY Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire) |
43.05; 42.28; 42.87; 42.47; 40.95; 42.18 | — |
| SECONDARY Analysis of the Proportion of Subjects With a Clinically Important Improvement of >=1 Point in the TDI (Transitional Dyspnoea Index)Focal Score by Visit |
43.3; 40.5; 52.6; 45.9 | — |
| SECONDARY Patient Reported Outcome Measures: COPD Assessment Test |
16.3; 16.2; 16.2; 16.2; 15.8; 16.8 | — |
| SECONDARY Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale |
49.6833; 49.7616; 49.6423; 49.9292; 50.9323; 50.0858 | — |
| SECONDARY Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale |
6.5565; 6.6203; 6.5702; 6.6351; 6.5717; 6.6246 | — |
| SECONDARY Summary Statistics of COPD Exacerbations over12 Weeks as Defined by Chronic Pulmonary Disease Tool (EXACT) |
0.2; 0.3 | — |
| SECONDARY Time to First COPD Exacerbation |
99.3; 98.7; 94.5; 88.5; 98.0; 98.3 | — |
| SECONDARY Annual Rate of COPD Exacerbations |
0.354; 0.659; 0.39; 0.73 | — |
| SECONDARY Duration (in Days) of COPD Exacerbations |
1.4; 2.0 | — |
| SECONDARY Percentage of Patients With at Least One Exacerbation up to Week 12 |
7.6; 14.1 | — |
| SECONDARY Time (in Days) to Permanent Study Discontinuation Due to COPD Exacerbation |
NA; NA | — |
| SECONDARY The Percentage of Patients Who Permanently Discontinued Due to COPD Exacerbation |
0.6; 1.6 | — |
| SECONDARY Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period |
100; NA; NA; 4.00; NA; 100 | — |
| SECONDARY Plasma Cortisol Concentrations at Each Timepoint |
328.5; 300.2; 284.0; 247.1; 249.1; 223.0 | — |
| SECONDARY Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint |
4.17; 4.32; 31.4; 111; 44.6; 89.7 | — |
| SECONDARY Pharmacokinetic Parameter: Cmax |
73.3; 215; 80.2; 263 | — |
| SECONDARY Pharmacokinetic Parameter--Tmax |
0.250; 0.970; 0.250; 1.00 | — |
| SECONDARY Pharmacokinetic Parameter--AUC0-t |
653; 2400; 693; 2760 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with moderate to very severe COPD (GOLD 2 to GOLD 4) according to the 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines
- Patients with a post-bronchodilator FEV1 12 hours per day.
- Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age 40 years.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01636076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.