Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease

Completed · Phase 4 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID: NCT01072396
Run by: Boehringer Ingelheim
People needed: 126
Starts: 2010-02-01
Expected to finish: 2011-11-01
Last updated by the study team: 2013-12-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

For COPD subjects: Male or female, age of 40 years or older, smoking history >10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio <70%., FEV1 >/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.

You may not qualify if…

Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.
Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.
Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.

Where it is running

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
205.440.1007 Boehringer Ingelheim Investigational Site — Spartanburg, South Carolina, United States
205.440.2003 Boehringer Ingelheim Investigational Site — Kingston, Ontario, Canada
205.440.2001 Boehringer Ingelheim Investigational Site — Montreal, Quebec, Canada
205.440.2004 Boehringer Ingelheim Investigational Site — Montreal, Quebec, Canada
205.440.2002 Boehringer Ingelheim Investigational Site — Ste-Foy, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.