Clinical trial NCT00274521: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: week 13
Secondary outcomes:
measure: Individual FEV1 measurement
timeFrame: week 4, 13, 25
measure: Individual FVC measurement
timeFrame: week 4, 13, 25
measure: St. George.s Hospital Respiratory Questionnaire (SGRQ)
timeFrame: week 4, 13, 25
measure: Transition dyspnea index
timeFrame: week 4, 13, 25
measure: COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
timeFrame: week 4, 13, 25
measure: Modified Borg scale
timeFrame: week 4, 13, 25
measure: Amount of albuterol therapy used during the treatment period
timeFrame: 25 weeks
measure: Number and length of exacerbations of COPD
timeFrame: 25 weeks
measure: Physician's global evaluation
timeFrame: week 4, 13, 25
measure: Patient peak flow rates twice daily
timeFrame: 25 weeks
measure: Patient activity measurement
timeFrame: week 9, 13, 17, 21, 25
measure: Change in submaximal exercise tolerance during constant work rate exercise
timeFrame: week 25
measure: Change in submaximal exercise tolerance prior to and after pulmonary rehabilitation.
timeFrame: week 13
measure: Occurrence of adverse events
timeFrame: 25 weeks
measure: Pulse rate and blood pressure in conjunction with spirometry
timeFrame: 25 weeks
measure: Changes in the physical examination from baseline and at the conclusion of patient participation in the trial
timeFrame: 25 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arizona
city: Deer Park
country: United States
facility: Attention: John E. Hodgkin, M.D.
state: California
city: Long Beach
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: San Diego
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Research and Education Institute
state: California
city: Fort Collins
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Colorado
city: Danbury
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Connecticut
city: Hartford
country: United States
facility: St. Francis Hospital and Medical Center
state: Connecticut
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Elk Grove Village
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Illinois
city: North Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Durhan
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Everett
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Washington
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: