Tiotropium (Spiriva) Rehabilitation Study
A Randomized, Double-blind, Placebo Controlled 25-week Trial to Compare the Effect of Tiotropium Inhalation Capsuled (18 Mcg) Once Daily on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD) Participating in 8 Weeks of Pulmonary Rehabilitation.
1 other identifier
interventional
108
1 country
19
Brief Summary
The study was designed to determine whether tiotropium inhalation capsules, compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation. In addition, assessments of the effect of tiotropium on dyspnea and quality of life following pulmonary rehabilitation were taken.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 9, 2006
CompletedFirst Posted
Study publicly available on registry
January 11, 2006
CompletedNovember 1, 2013
October 1, 2013
1.8 years
January 9, 2006
October 31, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the change in submaximal exercise tolerance (prior to treatment to after pulmonary rehabilitation) as measured by endurance time during a constant work rate treadmill exercise test at 80% of maximum work capacity
week 13
Secondary Outcomes (16)
Individual FEV1 measurement
week 4, 13, 25
Individual FVC measurement
week 4, 13, 25
St. George.s Hospital Respiratory Questionnaire (SGRQ)
week 4, 13, 25
Transition dyspnea index
week 4, 13, 25
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
week 4, 13, 25
- +11 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- History of COPD, FEV1 of less than or equal than 60% of predicted normal and less than or equal to 70% at Visit 1, Male or Female 40 years or greater, smoking history of more than 10 pack years (current or ex-smokers), patient can perform all study related tests, patients can inhale medication from HandiHaler and from meter dose inhaler, patients who would benefit from participation in a pulmonary rehab program and patients who had a medical clearance to participate in a pulmonary rehab program.
You may not qualify if:
- Patients with significant diseases other than COPD, patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis, all patients with SGOT greater than 80IU/L, bilirubin greater than 2.0 mg/dl or creatinine greater than 2.0 mg/dL, recent history of MI (6 months or less). any cardiac arrhythmia requiring drug therapy or has abeen hospitalized for heart failure with the past 3 years, active TB, history of CA or had treatment within the last 24 months, history of CF, bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
Attention: John E. Hodgkin, M.D.
Deer Park, California, United States
Boehringer Ingelheim Investigational Site
Long Beach, California, United States
UCLA School of Medicine
Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
San Diego, California, United States
Harbor-UCLA Research and Education Institute
Torrance, California, United States
Boehringer Ingelheim Investigational Site
Fort Collins, Colorado, United States
Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
Boehringer Ingelheim Investigational Site
Danbury, Connecticut, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Boehringer Ingelheim Investigational Site
Elk Grove Village, Illinois, United States
UMass Memorial Medical Center
North Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Duke University Medical Center
Durhan, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Boehringer Ingelheim Investigational Site
Everett, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 9, 2006
First Posted
January 11, 2006
Study Start
May 1, 2001
Primary Completion
February 1, 2003
Last Updated
November 1, 2013
Record last verified: 2013-10