A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Futicasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease ( COPD)
- Registration Number
- JPRN-jRCT2080222133
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 3332
* Written informed consent must be obtained before any assessment is performed
* Patients with stable Chronic Obstructive Pulmonary Disease ( COPD) according to the current GOLD strategy (GOLD 2011)
* Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)
* Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) >= 25 and < 60% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 0.70 at day -28. (Post refers to 1 hour after sequential inhalation of 84 micro-g (or equivalent dose) of ipratropium bromide and 400 micro-g of salbutamol)
* A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics
* Patients taking stable COPD medication (at least 60 days) prior to day -28
* Patients with an mMRC grade of at least 2 at day -28
*Patients requiring long term oxygen therapy prescribed for >12 hours per day.
*Patients who have had a respiratory tract infection within 4 weeks prior to screening Visit 1.
*Patients with any history of asthma.
*Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years
*Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded.
*Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
*Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study
Other protocol defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of COPD exacerbations [ Time Frame: 52 weeks ]<br>The rate of COPD exacerbations over 52 weeks of treatment.
- Secondary Outcome Measures
Name Time Method Time to first COPD exacerbation. [ Time Frame: 52 weeks ] <br>The time to the first COPD exacerbation over 52 weeks of treatment.<br>Rate of moderate to severe COPD exacerbations. [ Time Frame: 52 weeks ] <br>The rate of moderate to severe COPD exacerbations during 52 weeks of treatment.<br>Time to first moderate to severe COPD exacerbation. [ Time Frame: 52 weeks ]<br>The time to the first moderate to severe COPD exacerbation over 52 weeks of treatment.<br>The safety (with regard to ECG, laboratory tests, vital signs and adverse events)<br></body>