A study to compare the efficacy and safety of once daily QVA149 vs. the once daily concurrent administration of QAB149 plus NVA237 in patients with moderate to severe chronic obstructive pulmonary disease (CQVA149A2326)
- Conditions
- COPDchronic obstructive pulmonary disease10038716
- Registration Number
- NL-OMON37459
- Lead Sponsor
- ovartis Pharma BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
• Male or female adults aged >=40 years.
• Patients with moderate to severe COPD (Stage II-III) according to the (GOLD Guidelines, 2010).
• Current or ex-smokers who have a smoking history of at least 10 pack years.
• Post-bronchodilator FEV1 >=30% of the predicted normal value, and postbronchodilator FEV1/FVC < 0.70.
• COPD symptoms during run-in phase.
• Diabetes type I and uncontrolled diabetes type 2.
• History of long QT syndrome or QTc measured at Visit 2 (Fridericia method) is prolonged (>450 ms for males and females).
• BMI >=40 kg/m2.
• Patients who have had a COPD exacerbation in the 6 weeks prior to Visit 1.
• Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
• Pregnancy and breast feeding. Inadequate contraception, if relevant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Trough FEV1 week 4.</p><br>
- Secondary Outcome Measures
Name Time Method <p>FEV1, rescue medication, COPD symptoms, safety and tolerability.</p><br>