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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00531050 |
Purpose
This study will investigate the effect of exercise and high-dose salbutamol on the maximum heart rate in patients with chronic obstructive pulmonary disease (COPD) receiving therapeutic doses of indacaterol or placebo and salmeterol.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: QAB149 Drug: Placebo Drug: Salmeterol |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Pharmacokinetics Study |
| Official Title: | A Double-Blind, Randomized, Cross-Over, Placebo-Controlled, 2-Part Study to Compare the Effect of Exercise and High-Dose Salbutamol on Maximal Heart-Rate in Patients With COPD Following Therapeutic Doses of Inhaled QAB149 and Salmeterol |
| Estimated Enrollment: | 24 |
| Study Start Date: | August 2007 |
| Study Completion Date: | June 2008 |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
QAB149
|
Drug: QAB149 |
|
2: Placebo Comparator
Placebo
|
Drug: Placebo |
|
3: Active Comparator
Salmeterol
|
Drug: Salmeterol |
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Novartis ( External Affairs ) |
| Study ID Numbers: | CQAB149B2217 |
| Study First Received: | September 17, 2007 |
| Last Updated: | July 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00531050 History of Changes |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
|
COPD cycle ergometry exercise testing spirometry |
cardiovascular salbutamol indacaterol chronic obstructive pulmonary disease |
|
Respiratory System Agents Neurotransmitter Agents Salmeterol Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Respiration Disorders Albuterol Physiological Effects of Drugs Anti-Asthmatic Agents Reproductive Control Agents |
Adrenergic Agonists Pharmacologic Actions Lung Diseases, Obstructive Tocolytic Agents Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |