Tiotropium (Spiriva) Rehabilitation Study

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274521
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013
  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.

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual FEV1 measurement [ Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • Individual FVC measurement [ Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • St. George.s Hospital Respiratory Questionnaire (SGRQ) [ Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • Transition dyspnea index [ Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) [ Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • Modified Borg scale [ Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • Amount of albuterol therapy used during the treatment period [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Number and length of exacerbations of COPD [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Physician's global evaluation [ Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • Patient peak flow rates twice daily [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Patient activity measurement [ Time Frame: week 9, 13, 17, 21, 25 ] [ Designated as safety issue: No ]
  • Change in submaximal exercise tolerance during constant work rate exercise [ Time Frame: week 25 ] [ Designated as safety issue: No ]
  • Change in submaximal exercise tolerance prior to and after pulmonary rehabilitation. [ Time Frame: week 13 ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Pulse rate and blood pressure in conjunction with spirometry [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Changes in the physical examination from baseline and at the conclusion of patient participation in the trial [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274521

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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  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: October 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014