Status:
COMPLETED
Tiotropium / Respimat One Year Study in COPD.
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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 e...
Eligibility Criteria
Inclusion
- Male or female
- At least 40 years old
- Smoker or ex-smoker
- Smoking history \> 10 pack-years
- Forced Expiratory Volume in 1 Second (FEV1) \< 60% predicted
Exclusion
- Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
- History of asthma or allergic conditions.
- Malignancy requiring treatment within past 5 years
- Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
- Known active tuberculosis
- Known hypersensitivity to anticholinergic drugs.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
3991 Patients enrolled
Trial Details
Trial ID
NCT00387088
Start Date
September 1 2006
Last Update
May 16 2014
Active Locations (334)
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1
205.372.01012 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
205.372.01020 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
3
205.372.01062 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
4
205.372.01048 Boehringer Ingelheim Investigational Site
Berkeley, California, United States