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.
- NCT00274521
- PHASE3
- INTERVENTIONAL
Last updated: 2013-11-01
Purpose of Trial
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.
This study is for people with
Pulmonary Disease, Chronic Obstructive
Interventions being studied
Tiotropium
Inclusion Criteria:
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.
Exclusion Criteria:
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.
ELIGIBILITY
Gender: ALL
Age: 40+
Healthy Volunteers: No
19 Locations
Birmingham
University of Alabama at Birmingham
Alabama, United States
Phoenix
Boehringer Ingelheim Investigational Site
Arizona, United States
Deer Park
Attention: John E. Hodgkin, M.D.
California, United States
Long Beach
Boehringer Ingelheim Investigational Site
California, United States
Los Angeles
UCLA School of Medicine
California, United States
San Diego
Boehringer Ingelheim Investigational Site
California, United States
Torrance
Harbor-UCLA Research and Education Institute
California, United States
Fort Collins
Boehringer Ingelheim Investigational Site
Colorado, United States
Wheat Ridge
Boehringer Ingelheim Investigational Site
Colorado, United States
Danbury
Boehringer Ingelheim Investigational Site
Connecticut, United States
Hartford
St. Francis Hospital and Medical Center
Connecticut, United States
Norwalk
Norwalk Hospital
Connecticut, United States
Elk Grove Village
Boehringer Ingelheim Investigational Site
Illinois, United States
North Worcester
UMass Memorial Medical Center
Massachusetts, United States
Detroit
Henry Ford Hospital
Michigan, United States
Omaha
University of Nebraska Medical Center
Nebraska, United States
Durhan
Duke University Medical Center
North Carolina, United States
Philadelphia
Temple University Hospital
Pennsylvania, United States
Everett
Boehringer Ingelheim Investigational Site
Washington, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov