NCT00274521CompletedPhase 3
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 108
- Locations
- 19
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
Time Frame: week 13
Secondary Outcomes
- Individual FEV1 measurement(week 4, 13, 25)
- Amount of albuterol therapy used during the treatment period(25 weeks)
- Number and length of exacerbations of COPD(25 weeks)
- Individual FVC measurement(week 4, 13, 25)
- St. George.s Hospital Respiratory Questionnaire (SGRQ)(week 4, 13, 25)
- Modified Borg scale(week 4, 13, 25)
- Patient peak flow rates twice daily(25 weeks)
- Patient activity measurement(week 9, 13, 17, 21, 25)
- Change in submaximal exercise tolerance during constant work rate exercise(week 25)
- Transition dyspnea index(week 4, 13, 25)
- Pulse rate and blood pressure in conjunction with spirometry(25 weeks)
- Physician's global evaluation(week 4, 13, 25)
- COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)(week 4, 13, 25)
- Change in submaximal exercise tolerance prior to and after pulmonary rehabilitation.(week 13)
- Occurrence of adverse events(25 weeks)
- Changes in the physical examination from baseline and at the conclusion of patient participation in the trial(25 weeks)
Investigators
Study Sites (19)
Loading locations...
Similar Trials
Completed
Phase 3
Effect of Tiotropium Inhalation Capsules (Spiriva) on Exercise Tolerance in COPD PatientsPulmonary Disease, Chronic ObstructiveNCT00157235Boehringer Ingelheim234
Completed
Phase 3
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent AsthmaAsthmaNCT01634139Boehringer Ingelheim403
Completed
Phase 3
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent AsthmaAsthmaNCT01634152Boehringer Ingelheim401
Completed
Phase 3
Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent AsthmaAsthmaNCT01277523Boehringer Ingelheim392
Completed
Phase 2
An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent AsthmaAsthmaNCT00365560Boehringer Ingelheim115