Comparison of safety and efficacy of the combination product QVA149A against the concurrent administration of the individual components, QAB149 and NVA237, in patients with chronic obstructive pulmonary disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-006050-91-NL
- Lead Sponsor
- ovartis Pharma Service AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 184
•Male or female adults aged =40 yrs
•Smoking history of at least 10 pack years
•Diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2010)
•Post-bronchodilator FEV1 < 80% and = 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
Other protocol defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 92
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 92
•Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
•Patients with concomitant pulmonary disease
•Patients with a history of asthma
•Any patient with lung cancer or a history of lung cancer
•Patients with a history of certain cardiovascular co-morbid conditions
•Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
•Patients in the active phase of a supervised pulmonary rehabilitation program
•Patients contraindicated for inhaled anticholinergic agents and ß2 agonists
Other protocol defined inclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the non-inferiority of QVA149 110/50 µg qd as compared to concurrent administration of QAB149 150 µg qd plus NVA237 50 µg qd in terms of its effect on trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose) following 28 days of blinded treatment in patients with moderate to severe chronic obstructive pulmonary disease.;Secondary Objective: To evaluate the relative efficacy of QVA149 110/50 µg qd as compared to concurrent administration of QAB149 150 µg qd plus NVA237 50 µg qd in terms of:<br>•FEV1 AUC0-4h at Day 1<br>•FEV1 AUC0-4h at Day 28<br>•Daily number of puffs of rescue medication over 28 days of blinded treatment<br>•Symptoms reported over 28 days of blinded treatment using e-diary<br>•Safety and tolerability (adverse events, laboratory tests, ECGs, and vital signs)<br>;Primary end point(s): Trough Forced Expiratory Volume in 1 Second (FEV1) after 28 days of blinded treatment ;Timepoint(s) of evaluation of this end point: Timeframe: 28 days
- Secondary Outcome Measures
Name Time Method