Tiotropium (Spiriva) Rehabilitation Study
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Tiotropium |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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. |
- 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: 8 weeks ]
- Individual FEV1 and FVC measurements at each time point, St. George's Hospital Respiratory Questionnaire (SQRQ), Transition Dyspnea index, COPD symptom scores, modified Borg scale, amount of albuterol therapy used during the treatment period. [ Time Frame: 25 weeks ]
| Estimated Enrollment: | 110 |
| Study Start Date: | May 2001 |
| Estimated Study Completion Date: | August 2003 |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Boehringer Ingelheim Investigational Site | |
| Phoenix, Arizona, United States | |
| United States, California | |
| 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 | |
| United States, Colorado | |
| Boehringer Ingelheim Investigational Site | |
| Fort Collins, Colorado, United States | |
| Boehringer Ingelheim Investigational Site | |
| Wheat Ridge, Colorado, United States | |
| United States, Connecticut | |
| Boehringer Ingelheim Investigational Site | |
| Danbury, Connecticut, United States | |
| St. Francis Hospital and Medical Center | |
| Hartford, Connecticut, United States | |
| Norwalk Hospital | |
| Norwalk, Connecticut, United States | |
| United States, Illinois | |
| Boehringer Ingelheim Investigational Site | |
| Elk Grove Village, Illinois, United States | |
| United States, Massachusetts | |
| UMass Memorial Medical Center | |
| North Worcester, Massachusetts, United States | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durhan, North Carolina, United States | |
| United States, Pennsylvania | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States | |
| United States, Washington | |
| Boehringer Ingelheim Investigational Site | |
| Everett, Washington, United States | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00274521 History of Changes |
| Other Study ID Numbers: | 205.230 |
| Study First Received: | January 9, 2006 |
| Last Updated: | May 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Tiotropium Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013