Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Health Condition 1: null- Chronic Obstructive Pulmonary Disease
- Registration Number
- CTRI/2010/091/000285
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 360
Male and Female patients age 40 years or more
Diagnosis of COPD (moderate-to-severe 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 <80% and >=30% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced vital capacity) <0.7
*Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 6 weeks prior to the first visit
* Patients who have had a respiratory tract infection within 4 weeks prior to the first visit
* Patients with concomitant pulmonary disease or a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions
* Patients with eczema, known high IgE levels or a known positive skin prick test
* Patients participating in the active phase of a pulmonary rehabilitation programme
* Other protocol-defined inclusion/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