Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Placebo
- Registration Number
- NCT01072396
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 18 mcg tiotropium Tiotropium Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler Placebo Placebo Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
- Primary Outcome Measures
Name Time Method Change From Baseline in Inspiratory Capacity (IC) at Isotime baseline, six weeks of treatment 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.
- Secondary Outcome Measures
Name Time Method Constant Work Rate (CWR) Endurance Time six weeks of treatment CWR exercise duration calculated as the length of time of the exercise period
Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime baseline, six weeks of treatment 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).
Trial Locations
- Locations (15)
205.440.1002 Boehringer Ingelheim Investigational Site
🇺🇸Torrance, California, United States
205.440.1018 Boehringer Ingelheim Investigational Site
🇺🇸Hartford, Connecticut, United States
205.440.1015 Boehringer Ingelheim Investigational Site
🇺🇸Jasper, Alabama, United States
205.440.1017 Boehringer Ingelheim Investigational Site
🇺🇸Muncie, Indiana, United States
205.440.2003 Boehringer Ingelheim Investigational Site
🇨🇦Kingston, Ontario, Canada
205.440.1006 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
205.440.1013 Boehringer Ingelheim Investigational Site
🇺🇸Pittsburgh, Pennsylvania, United States
205.440.2002 Boehringer Ingelheim Investigational Site
🇨🇦Ste-Foy, Quebec, Canada
205.440.1019 Boehringer Ingelheim Investigational Site
🇺🇸Charlotte, North Carolina, United States
205.440.1011 Boehringer Ingelheim Investigational Site
🇺🇸Lebanon, New Hampshire, United States
205.440.2001 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
205.440.1008 Boehringer Ingelheim Investigational Site
🇺🇸Springfield, Illinois, United States
205.440.1007 Boehringer Ingelheim Investigational Site
🇺🇸Spartanburg, South Carolina, United States
205.440.2004 Boehringer Ingelheim Investigational Site
🇨🇦Montreal, Quebec, Canada
205.440.1020 Boehringer Ingelheim Investigational Site
🇺🇸Livonia, Michigan, United States