Effect of QVA149 Versus NVA237 on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations
- Conditions
- Health Condition 1: null- Chronic Obstructive Pulmonary Disease
- Registration Number
- CTRI/2010/091/000665
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2200
Male or female adults aged greater than or equal to 40 yrs
Severe or very COPD [Stage III or IV as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008]
Smoking history of at least 10 pack years
Post-bronchodilator FEV1 less than 50 percent of the predicted normal value and post- bronchodilator FEV1 or FVC less than 70percent
Documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and or antibiotics
Patients requiring long term oxygen therapy (greater than 15 h a day) on a daily basis for chronic hypoxemia
Patients who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1
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
Other protocol-defined inclusion or exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method