Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis

Criteria

Inclusion Criteria:

• 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.

1. Patients must complete Stage 2 of the core study B2335S (NCT00463567).

2. Written informed consent to participate in the extension must be obtained.

3. Patients must be able to comply with all study requirements.

Exclusion Criteria:

• 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.

Other protocol-defined inclusion/exclusion criteria may apply