To evaluate safety and efficacy of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Health Condition 1: null- Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- CTRI/2009/091/000187
- Lead Sponsor
- ovartis Health Care Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 336
Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and:
Smoking history of at least 20 pack-years
Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia
Patients who have had a respiratory tract infection within 6 weeks prior to screening
Patients with concomitant pulmonary disease
Patients with 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
Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged
Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
Patients unable to successfully use a dry powder inhaler device, or perform spirometry measurements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method