Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Sites / Locations
- 205.440.1006 Boehringer Ingelheim Investigational Site
- 205.440.1015 Boehringer Ingelheim Investigational Site
- 205.440.1002 Boehringer Ingelheim Investigational Site
- 205.440.1018 Boehringer Ingelheim Investigational Site
- 205.440.1008 Boehringer Ingelheim Investigational Site
- 205.440.1017 Boehringer Ingelheim Investigational Site
- 205.440.1020 Boehringer Ingelheim Investigational Site
- 205.440.1011 Boehringer Ingelheim Investigational Site
- 205.440.1019 Boehringer Ingelheim Investigational Site
- 205.440.1013 Boehringer Ingelheim Investigational Site
- 205.440.1007 Boehringer Ingelheim Investigational Site
- 205.440.2003 Boehringer Ingelheim Investigational Site
- 205.440.2001 Boehringer Ingelheim Investigational Site
- 205.440.2004 Boehringer Ingelheim Investigational Site
- 205.440.2002 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Placebo Comparator
No Intervention
18 mcg tiotropium
Placebo
Control
Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD