Effect of Tiotropium (Spiriva) on Exercise Tolerance in COPD Patients
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00274508
First received: January 9, 2006
Last updated: May 11, 2012
Last verified: May 2012
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Purpose
To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: tiotropium bromide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Effect of Tiotropium on Exercise Tolerance and Static and Dynamic Lung Volumes in COPD Patients (A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study) |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Exercise and Physical Fitness
Drug Information available for:
Tiotropium bromide
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Evaluation of constant work rate exercise endurance (as measured by endurance time during a constant work rate exercise test to symptom limitation, 2 hours 15 minutes post-dose after 6 weeks of treatment)
Secondary Outcome Measures:
- Evaluation of dyspnea during constant work rate exercise test as measured by the modified Borg Scale; evaluation of static and dynamic lung hyperinflation as determined by inspiratory capacity (IC) at rest and during exercise
| Estimated Enrollment: | 260 |
| Study Start Date: | October 2000 |
| Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274508
Show 28 Study Locations
Show 28 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00274508 History of Changes |
| Other Study ID Numbers: | 205.223 |
| Study First Received: | January 9, 2006 |
| Last Updated: | May 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Lung Diseases, Obstructive Bromides Tiotropium Anticonvulsants Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on October 16, 2012
