Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
126
double blind randomized crossover
inhalation powder capsule identical to those containing tiotropium bromide inhalation powder
205.440.1006 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
205.440.1015 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
205.440.1002 Boehringer Ingelheim Investigational Site
Torrance, California, United States
205.440.1018 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
205.440.1008 Boehringer Ingelheim Investigational Site
Springfield, Illinois, United States
205.440.1017 Boehringer Ingelheim Investigational Site
Muncie, Indiana, United States
205.440.1020 Boehringer Ingelheim Investigational Site
Livonia, Michigan, United States
205.440.1011 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire, United States
205.440.1019 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
205.440.1013 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
...and 5 more locations
Change From Baseline in Inspiratory Capacity (IC) at Isotime
Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate.
Time frame: baseline, six weeks of treatment
Constant Work Rate (CWR) Endurance Time
CWR exercise duration calculated as the length of time of the exercise period
Time frame: six weeks of treatment
Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime
Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced).
Time frame: baseline, six weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.