Status:
COMPLETED
Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea
Lead Sponsor:
The Korean Academy of Tuberculosis and Respiratory Diseases
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief Summary
Study title * A randomized, open label, multicenter, phase 4 study for the comparison of efficacy of tiotropium plus salmeterol/ fluticasone propionate compared with tiotropium alone in COPD patients...
Eligibility Criteria
Inclusion
- Subjects Aged 40 to 80 years.
- Subjects diagnosed with COPD.
- Tobacco smoking 10 pack-years or more.
- Subjects with post-bronchodilator FEV1/FVC \< 0.7 and FEV1 \< 65% predicted.
Exclusion
- Subjects with a history of physician-diagnosed asthma or a respiratory disorder other than COPD which is clinically significant such as diffuse bilateral bronchiectasis.
- Subjects suffering from serious diseases likely to interfere with the study such as chronic congestive heart failure.
- Subjects who used systemic corticosteroids within 4 weeks prior to study entry.
- Subjects with any malignant disease.
- Subjects with a history of severe glaucoma, urinary tract obstruction.
- Previous lung volume reduction surgery.
- Subjects who are pregnant or breastfeeding.
- Subjects with a known hypersensitivity or intolerance to tiotropium or fluticasone-salmeterol.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
509 Patients enrolled
Trial Details
Trial ID
NCT00864812
Start Date
March 1 2009
End Date
March 1 2010
Last Update
March 31 2010
Active Locations (32)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
2
Inje university Pusan Paik hospital
Busan, South Korea
3
Chonbuk national university hospital
Chunbuk, South Korea
4
Keimyung university dongsan medical center
Daegu, South Korea