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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00620022 |
The study will compare the effect of indacaterol on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease |
Drug: Indacaterol 300 µg delivered via SDDPI Drug: Placebo to indacaterol delivered via SDDPI |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Phase III Randomized, Double-Blind, Placebo Controlled, 2 Period Crossover, Multicenter Study to Assess the Effect of Indacaterol (300 µg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) |
Estimated Enrollment: | 83 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Indacaterol 300 µg delivered via SDDPI
Indacaterol 300 µg delivered via SDDPI
|
2: Placebo Comparator |
Drug: Placebo to indacaterol delivered via SDDPI
Placebo to indacaterol delivered via SDDPI
|
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2006) and:
Exclusion Criteria:
United States, California | |
Novartis Investigator Site | |
Torrance, California, United States | |
United States, New Hampshire | |
Novartis Investigator Site | |
Lebanon, New Hampshire, United States | |
Belgium | |
Novartis Investigator Site | |
Bruxelles, Belgium | |
Novartis Investigator Site | |
Jette, Belgium | |
Novartis Investigator Site | |
Gembloux, Belgium | |
Novartis Investigator Site | |
Liege, Belgium | |
Canada | |
Novartis Investigator Site | |
Kingston, Canada | |
Novartis Investigator Site | |
Edmonton, Canada | |
Denmark | |
Novartis Investigative Site | |
Hellerup, Denmark | |
Novartis Investigator Site | |
Aarhus, Denmark | |
Novartis Investigator Site | |
Hvidovre, Denmark | |
Novartis Investigative site | |
Odense, Denmark | |
Italy | |
Novartis Investigator Site | |
Genova, Italy | |
Novartis Investigator Site | |
Verona, Italy | |
Novartis Investigator Site | |
Pisa, Italy | |
Spain | |
Novartis Investigative site | |
Seville, Spain | |
Novartis Investigator Site | |
Zaragoza, Spain | |
Novartis Investigator Site | |
Barcelona, Spain | |
Novartis Investigator Site | |
Alicante, Spain | |
Novartis Investigative Site | |
Madrid, Spain |
Study Chair: | Novartis Pharma | Novartis Pharma |
Responsible Party: | novartis ( external affairs ) |
Study ID Numbers: | CQAB149B2311 |
Study First Received: | February 8, 2008 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00620022 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Belgium: Federal Agency for Medicinal Products and Health Products; Denmark: Danish Medicines Agency; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines |
Indacaterol chronic obstructive pulmonary disease exercise endurance Moderate to severe chronic obstructive pulmonary disease |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |