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

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ClinicalTrials.gov Identifier: NCT00274508
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : November 1, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Brief Summary:
To investigate whether tiotropium (Spiriva) improves exercise endurance in patients with COPD

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: tiotropium bromide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : October 2000
Actual Primary Completion Date : January 2003

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Primary Outcome Measures :
  1. 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 :
  1. Constant work rate exercise test to symptom limitation [ Time Frame: 8 hours post-dose after 6 weeks of treatment ]
  2. Breathing discomfort during constant work rate exercise test as measured by the modified Borg Scale [ Time Frame: 6 weeks ]
  3. Dynamic lung hyperinflation during exercise as determined by IRVdyn (IC minus VT) and EELVdyn (TLC) [ Time Frame: 6 weeks ]
  4. Evaluation of VE and VEcap during exercise (selected centers) [ Time Frame: 6 weeks ]
  5. Evaluation of static lung hyperinflation as measured by RV/TLC and by TGV(FRC)/TLC [ Time Frame: 6 weeks ]
  6. Evaluation of TAC (TAV = TLC(BOX)-VA(IG)) [ Time Frame: 6 weeks ]
  7. Evaluation of slow vital capacity (SVC) [ Time Frame: 6 weeks ]
  8. Evaluation of maximal expiratory flow rates and volumes FEV1, FVC, FEF25-75%, FEF50%, FEF75%, SVC [ Time Frame: 6 weeks ]
  9. Evaluation of TGV, Raw, SGaw and RV [ Time Frame: 6 weeks ]
  10. Evaluation of SaO2, VO2, VCO2, Ti, Te, VE, VT, breathing frequency (f) during constant work rate exercise test [ Time Frame: 6 weeks ]
  11. Physician's Global Assessment [ Time Frame: 6 weeks ]
  12. Assessement of Pulse/heart rate and blood pressure in conjunction with spirometry and exercise [ Time Frame: 6 weeks ]
  13. Changes in Physical examination and ECG [ Time Frame: 6 weeks ]
  14. Occurrence of Adverse Events [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274508


  Show 28 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim

ClinicalTrials.gov Identifier: NCT00274508     History of Changes
Other Study ID Numbers: 205.223
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 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
Bromides
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants