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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: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 27 |
| Study Start Date: | August 2007 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
QAB149
|
Drug: QAB149
Other Name: indacaterol
|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo |
|
Active Comparator: 3
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: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00531050 History of Changes |
| Other Study ID Numbers: | CQAB149B2217 |
| Study First Received: | September 17, 2007 |
| Last Updated: | April 1, 2011 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
|
COPD cycle ergometry exercise testing spirometry |
cardiovascular salbutamol indacaterol chronic obstructive pulmonary disease |
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Albuterol Salmeterol Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |