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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274508
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013
  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:


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)
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274508

  Show 28 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  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: October 31, 2013
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 July 22, 2014