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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Individual FEV1 measurement | week 4, 13, 25 | |
| Individual FVC measurement | week 4, 13, 25 | |
| St. George.s Hospital Respiratory Questionnaire (SGRQ) |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | United States | |||
| Boehringer Ingelheim Investigational Site |
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| 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 |
| Modified Borg scale | week 4, 13, 25 |
| Amount of albuterol therapy used during the treatment period | 25 weeks |
| Number and length of exacerbations of COPD | 25 weeks |
| Physician's global evaluation | 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 |
| Change in submaximal exercise tolerance prior to and after pulmonary rehabilitation. | week 13 |
| Occurrence of adverse events | 25 weeks |
| Pulse rate and blood pressure in conjunction with spirometry | 25 weeks |
| Changes in the physical examination from baseline and at the conclusion of patient participation in the trial | 25 weeks |
| 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 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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