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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00615030 |
This study is being conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second [FEV1]) over the full 24-h time period
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: Indacaterol Drug: Salmeterol Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 µg o.d. Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 µg b.i.d. as Active Control |
Estimated Enrollment: | 78 |
Study Start Date: | January 2008 |
Study Completion Date: | August 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Indacaterol
300 µg dosed in the evening via SDDPI
|
2: Active Comparator |
Drug: Indacaterol
300 µg dosed in the morning via SDDPI
|
3: Active Comparator |
Drug: Salmeterol
50 µg twice daily delivered via manufacturer's dry powder inhaler
|
4: Placebo Comparator |
Drug: placebo
placebo to indacaterol and salmeterol
|
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
France | |
Novartis Investigative Site | |
Beuvry, France | |
Novartis Investigative Site | |
Nantes, France | |
Germany | |
Novartis Investigative Site | |
Berlin, Germany | |
Novartis Investigative Site | |
Hamburg, Germany | |
Novartis Investigative Site | |
Mainz, Germany | |
Novartis Investigative Site | |
Berlin, Germany | |
Novartis Investigative Site | |
Leipzig, Germany | |
Spain | |
Novartis Investigative Site | |
Barcelona, Spain | |
Novartis Investigative Site | |
Barcelona, Spain |
Principal Investigator: | Novartis Pharmaceuticals | + 41 61 324 1111 |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CQAB149B2305 |
Study First Received: | February 1, 2008 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00615030 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
COPD, bronchodilator, long acting beta agonist, LABA |
Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases |
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents |
Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |