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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
108
University of Alabama at Birmingham
Birmingham, Alabama, United States
Boehringer Ingelheim Investigational Site
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Phoenix, Arizona, United States
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
Boehringer Ingelheim Investigational Site
Fort Collins, Colorado, United States
Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
Boehringer Ingelheim Investigational Site
Danbury, Connecticut, United States
...and 9 more locations
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