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Tiotropium (Spiriva) Rehabilitation Study

This study has been completed.
Information provided by:
Boehringer Ingelheim Identifier:
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013
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
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.

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Individual FEV1 measurement [ Time Frame: week 4, 13, 25 ]
  • Individual FVC measurement [ Time Frame: week 4, 13, 25 ]
  • St. George.s Hospital Respiratory Questionnaire (SGRQ) [ Time Frame: week 4, 13, 25 ]
  • Transition dyspnea index [ Time Frame: week 4, 13, 25 ]
  • COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) [ Time Frame: week 4, 13, 25 ]
  • Modified Borg scale [ Time Frame: week 4, 13, 25 ]
  • Amount of albuterol therapy used during the treatment period [ Time Frame: 25 weeks ]
  • Number and length of exacerbations of COPD [ Time Frame: 25 weeks ]
  • Physician's global evaluation [ Time Frame: week 4, 13, 25 ]
  • Patient peak flow rates twice daily [ Time Frame: 25 weeks ]
  • Patient activity measurement [ Time Frame: week 9, 13, 17, 21, 25 ]
  • Change in submaximal exercise tolerance during constant work rate exercise [ Time Frame: week 25 ]
  • Change in submaximal exercise tolerance prior to and after pulmonary rehabilitation. [ Time Frame: week 13 ]
  • Occurrence of adverse events [ Time Frame: 25 weeks ]
  • Pulse rate and blood pressure in conjunction with spirometry [ Time Frame: 25 weeks ]
  • Changes in the physical examination from baseline and at the conclusion of patient participation in the trial [ Time Frame: 25 weeks ]

Estimated Enrollment: 108
Study Start Date: May 2001
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00274521

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
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information Identifier: NCT00274521     History of Changes
Other Study ID Numbers: 205.230
Study First Received: January 9, 2006
Last Updated: October 31, 2013

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017