A 52-week treatment, multi-center, randomized, doubleblind, double dummy, parallel-group, active controlled study to compare the effect of QVA149 (indacaterol maleate / glycopyrronium bromide) with salmeterol/fluticasone on the rate of exacerbations in subjects with moderate to very severe COPD (CQVA149A2318)
- Conditions
- COPD10038716
- Registration Number
- NL-OMON41239
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
* Male or female adults aged *40 years.
* Patients with stable COPD according to the (GOLD Guidelines, 2011).
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Post-bronchodilator FEV1 *25% and < 60% of the predicted normal value, and postbronchodilator FEV1/FVC < 0.70.
* At least 1 exacerbation in the previous 12 months.
* Patients taking stable COPD medication (at least 60 days).
* mMRC grade of at least 2.
* 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).
* 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>Exacerbation rate.</p><br>
- Secondary Outcome Measures
Name Time Method <p>FEV1, St George questionnaire, rescue medication, COPD symptoms, safety and<br /><br>tolerability.</p><br>