Tiotropium (Spiriva) Rehabilitation Study

Pulmonary Disease, Chronic Obstructive Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274521
• Other study ID #: 205.230
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2006
• Last updated: October 31, 2013
• Start date: May 2001

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boehringer Ingelheim Investigational Site	Danbury	Connecticut
United States	Attention: John E. Hodgkin, M.D.	Deer Park	California
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durhan	North Carolina
United States	Boehringer Ingelheim Investigational Site	Elk Grove Village	Illinois
United States	Boehringer Ingelheim Investigational Site	Everett	Washington
United States	Boehringer Ingelheim Investigational Site	Fort Collins	Colorado
United States	St. Francis Hospital and Medical Center	Hartford	Connecticut
United States	Boehringer Ingelheim Investigational Site	Long Beach	California
United States	UCLA School of Medicine	Los Angeles	California
United States	UMass Memorial Medical Center	North Worcester	Massachusetts
United States	Norwalk Hospital	Norwalk	Connecticut
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Boehringer Ingelheim Investigational Site	Phoenix	Arizona
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	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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