Tiotropium / Respimat One Year Study in COPD.

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tiotropium Bromide

Criteria

Inclusion Criteria:

1. Male or female

2. At least 40 years old

3. Smoker or ex-smoker

4. Smoking history > 10 pack-years

5. Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

Exclusion Criteria:

1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure

2. History of asthma or allergic conditions.

3. Malignancy requiring treatment within past 5 years

4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis

5. Known active tuberculosis

6. Known hypersensitivity to anticholinergic drugs.