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

This study has been completed.
Information provided by:
Boehringer Ingelheim 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 ]

Secondary Outcome Measures:
  • Constant work rate exercise test to symptom limitation [ Time Frame: 8 hours post-dose after 6 weeks of treatment ]
  • Breathing discomfort during constant work rate exercise test as measured by the modified Borg Scale [ Time Frame: 6 weeks ]
  • Dynamic lung hyperinflation during exercise as determined by IRVdyn (IC minus VT) and EELVdyn (TLC) [ Time Frame: 6 weeks ]
  • Evaluation of VE and VEcap during exercise (selected centers) [ Time Frame: 6 weeks ]
  • Evaluation of static lung hyperinflation as measured by RV/TLC and by TGV(FRC)/TLC [ Time Frame: 6 weeks ]
  • Evaluation of TAC (TAV = TLC(BOX)-VA(IG)) [ Time Frame: 6 weeks ]
  • Evaluation of slow vital capacity (SVC) [ Time Frame: 6 weeks ]
  • Evaluation of maximal expiratory flow rates and volumes FEV1, FVC, FEF25-75%, FEF50%, FEF75%, SVC [ Time Frame: 6 weeks ]
  • Evaluation of TGV, Raw, SGaw and RV [ Time Frame: 6 weeks ]
  • Evaluation of SaO2, VO2, VCO2, Ti, Te, VE, VT, breathing frequency (f) during constant work rate exercise test [ Time Frame: 6 weeks ]
  • Physician's Global Assessment [ Time Frame: 6 weeks ]
  • Assessement of Pulse/heart rate and blood pressure in conjunction with spirometry and exercise [ Time Frame: 6 weeks ]
  • Changes in Physical examination and ECG [ Time Frame: 6 weeks ]
  • Occurrence of Adverse Events [ Time Frame: 6 weeks ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  Contacts and Locations
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Please refer to this study by its identifier: NCT00274508

  Show 28 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information Identifier: NCT00274508     History of Changes
Other Study ID Numbers: 205.223
Study First Received: January 9, 2006
Last Updated: October 31, 2013

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants processed this record on June 23, 2017