Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Health Condition 1: null- Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- CTRI/2009/091/000216
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 418
Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE)
In addition the following inclusion/exclusion criteria specified below must be met.
Patients must complete Stage 2 of the core study B2335S.
Written informed consent to participate in the extension must be obtained.
Patients must be able to comply with all study requirements.
*Patients who were randomized to open-label tiotropium in Study B2335S.
* Patients who participated in Stage 1 of the core study (B2335S).
*Patients discontinued irrespective of the reason from Stage 2 of the core study.
*Patients who fail to comply with the core protocol requirements and procedures.
*Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
*Patients who in the Investigator's opinion should not-participate in the extension study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety profile of two doses of indacaterol compared to placebo over 52 weeks of treatmentTimepoint: 52 weeks of treatment
- Secondary Outcome Measures
Name Time Method ExacerbationsTimepoint: time to the first exacerbation;Pharmacokinetic profile at the baseline, and last visitTimepoint: 52 weeks of treatment;Quality of life assessment with St George's Respiratory Questionnaire (SGRQ) at baseline, and last visitTimepoint: 52 weeks of treatment;Trough forced expiratory volume in 1 second (FEV1) assessment at baseline, last visitTimepoint: 52 weeks of treatment