Status:
COMPLETED
Tiotropium and Salmeterol PK Study in COPD Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to characterize the pharmacokinetics (i.e. systemic exposure to tiotropium and salmeterol) of tiotropium qd + salmeterol qd or bid versus tiotropium qd and salme...
Eligibility Criteria
Inclusion
- COPD patients of \>= 40 years old with moderate to severe COPD who are current or ex-smokers with a smoking history of at least 10 pack-years
Exclusion
- Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
- History of asthma
- Malignancy requiring treatment within past 5 years
- Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
- Known active tuberculosis
- Pregnant or nusing women
- Known hypersensitivity to components of the study medication
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00673478
Start Date
May 1 2008
Last Update
May 16 2014
Active Locations (3)
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1
1184.24.32001 Boehringer Ingelheim Investigational Site
Genk, Belgium
2
1184.24.32002 Boehringer Ingelheim Investigational Site
Hasselt, Belgium
3
1184.24.31001 Boehringer Ingelheim Investigational Site
Heerlen, Netherlands