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

A 26-Week Extension to a 26-Week Treatment, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive, Seamless, Parallel-Group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000216

Enrollment

418

Registered

2009-05-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Intervention1: Indacaterol 150 Âµg: Indacaterol 150 Âµg via single-dose dry-powder inhaler (SDDPI), Once a daily till 26 weeks Intervention2: Indacaterol 300 Âµg: Indacaterol 300 Âµg od via SDDPI, Onc

Eligibility

Inclusion 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. 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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Safety profile of two doses of indacaterol compared to placebo over 52 weeks of treatmentTimepoint: 52 weeks of treatment	—

Secondary

Measure	Time frame
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	—

Countries

Argentina, Canada, Germany, India, Italy, Spain, Sweden, Turkey, United States of America

Contacts

Public ContactKMurugananthan

Novartis Health Care Pvt Ltd

murugananthan.k@novartis.com02224958545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026