Effect of Tiotropium (Spiriva) on Exercise Tolerance in COPD Patients

This study has been completed.
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013
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:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Endurance time during a constant work rate exercise test to symptom limitation [ Time Frame: 2 hours and 15 minutes after trial medication administration on Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Constant work rate exercise test to symptom limitation [ Time Frame: 8 hours post-dose after 6 weeks of treatment ] [ Designated as safety issue: No ]
  • Breathing discomfort during constant work rate exercise test as measured by the modified Borg Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Dynamic lung hyperinflation during exercise as determined by IRVdyn (IC minus VT) and EELVdyn (TLC) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Evaluation of VE and VEcap during exercise (selected centers) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Evaluation of static lung hyperinflation as measured by RV/TLC and by TGV(FRC)/TLC [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Evaluation of TAC (TAV = TLC(BOX)-VA(IG)) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Evaluation of slow vital capacity (SVC) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Evaluation of maximal expiratory flow rates and volumes FEV1, FVC, FEF25-75%, FEF50%, FEF75%, SVC [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Evaluation of TGV, Raw, SGaw and RV [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Evaluation of SaO2, VO2, VCO2, Ti, Te, VE, VT, breathing frequency (f) during constant work rate exercise test [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Physician's Global Assessment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Assessement of Pulse/heart rate and blood pressure in conjunction with spirometry and exercise [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Changes in Physical examination and ECG [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Occurrence of Adverse Events [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 261
Study Start Date: October 2000
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00274508

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Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00274508     History of Changes
Other Study ID Numbers: 205.223 
Study First Received: January 9, 2006
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Tiotropium Bromide
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on May 26, 2016