A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149
Source: ClinicalTrials.gov NCT01709903 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d |
1.248; 1.176 | — |
| SECONDARY Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Superiority of QVA 110/50μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d |
1.259; 1.183 | — |
| SECONDARY Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-4 Hours |
1.317; 1.252; 1.388; 1.262; 1.351; 1.229 | — |
| SECONDARY Analysis of FEV1 (L) Trough Response (Pre-dose) Over the Whole Treatment Period |
1.256; 1.184; 1.265; 1.191; 1.252; 1.174 | — |
| SECONDARY Analysis of Trough FVC (L) Over the Whole Treatment Period |
3.040; 2.957; 3.036; 2.835; 2.966; 2.793 | — |
| SECONDARY Health Related Quality of Life Analysis of SGRQ Total Score After 26 Weeks of Treatment |
31.20; 32.00; 31.74; 32.43 | — |
| SECONDARY Analysis of the TDI Focal Score Over the Whole Treatment Period |
6.36; 6.36; 2.62; 2.40; 6.38; 6.40 | — |
| SECONDARY Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals |
1.57; 1.69; 0.66; 0.61; 1.25; 1.24 | — |
| SECONDARY Symptoms Reported Using E-diary Over 12 and 26 Weeks of Treatment |
67.57; 67.86; 7.31; 10.22; 44.02; 42.16 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with moderate to severe stable COPD (Stage II or Stage III) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline.
Current or ex-smokers who have a smoking history of at least 10 pack years. Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥ 30% and 450 ms for males and females) as confirmed by the central Electrocardiogram (ECG) assessor.
Patients with Type I or uncontrolled Type II diabetes. Patients who have not achieved spirometry result at Visit 2 in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria for acceptability and repeatability.
Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age 40 years.
Patients with concomitant pulmonary disease (e.g. lung fibrosis, primary bronchiectasis, sarcoidosis, interstitial lung disorder, pulmonary hypertension).
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01709903). 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.