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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00677807

Purpose

This study will evaluate 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of COPD patients

Condition	Intervention	Phase
COPD	Drug: Indacaterol 150 µg o.d. Drug: Indacaterol 300 µg o.d. Drug: Placebo o.d.	Phase III

Drug Information available for: Indacaterol

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety profile of two doses of indacaterol compared to placebo over 52 weeks of treatment

Secondary Outcome Measures:

Trough forced expiratory volume in 1 second (FEV1) assessment at baseline, last visit
Exacerbations (time to the first exacerbation)
Control of COPD (number of days with poor control, usage of rescue medication)
Quality of life assessment with St George's Respiratory Questionnaire (SGRQ) at baseline, and last visit
Pharmacokinetic profile at the baseline, and last visit

Estimated Enrollment:	418
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)	Drug: Indacaterol 150 µg o.d.
2: Experimental Indacaterol 300 µg o.d. via SDDPI	Drug: Indacaterol 300 µg o.d.
3: Placebo Comparator Placebo o.d. via SDDPI	Drug: Placebo o.d.

Eligibility

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.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677807

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CQAB149B2335SE, EudraCT number 2008-000663-42
Study First Received:	May 13, 2008
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00677807
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Canada: Health Canada; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; India: Institutional Review Board; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Turkey: Ministry of Health

Keywords provided by Novartis:

COPD
adults
β2-agonist
indacaterol

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 14, 2009