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Tiotropium (Spiriva) Rehabilitation Study

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tiotropium
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Boehringer Ingelheim Investigational Site
  • Attention: John E. Hodgkin, M.D.
  • Boehringer Ingelheim Investigational Site
  • UCLA School of Medicine
  • Boehringer Ingelheim Investigational Site
  • Harbor-UCLA Research and Education Institute
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • St. Francis Hospital and Medical Center
  • Norwalk Hospital
  • Boehringer Ingelheim Investigational Site
  • UMass Memorial Medical Center
  • Henry Ford Hospital
  • University of Nebraska Medical Center
  • Duke University Medical Center
  • Temple University Hospital
  • Boehringer Ingelheim Investigational Site

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2006
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00274521
Brief Title
Tiotropium (Spiriva) Rehabilitation Study
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
108 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Attention: John E. Hodgkin, M.D.
City
Deer Park
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Harbor-UCLA Research and Education Institute
City
Torrance
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Fort Collins
State/Province
Colorado
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Danbury
State/Province
Connecticut
Country
United States
Facility Name
St. Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Elk Grove Village
State/Province
Illinois
Country
United States
Facility Name
UMass Memorial Medical Center
City
North Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Duke University Medical Center
City
Durhan
State/Province
North Carolina
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Everett
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.230_literature.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.230_U03-3251.pdf
Description
Related Info

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Tiotropium (Spiriva) Rehabilitation Study

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