Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea
NCT ID: NCT00864812
Last Updated: 2010-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
509 participants
INTERVENTIONAL
2009-03-31
2010-03-31
Brief Summary
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* 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
Study objectives
* To investigate clinical outcomes of combining tiotropium with fluticasone propionate/salmeterol (FSC) 250/50μg bid compared with tiotropium alone in patients with moderate or severe COPD in Korea
Study Design
* Randomized, open-label, multicenter, parallel-group, two group study
Study assessment
* FEV1
* Inspiratory capacity (IC)
* History of COPD exacerbation
* History of hospitalization for COPD exacerbation and all causes
* QoL (SGRQ-C)
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
tiotropium with fluticasone propionate/salmeterol (FSC)
tiotropium with fluticasone propionate/salmeterol (FSC)
COPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC)
2
tiotropium
tiotropium
COPD patients treated with tiotropium
Interventions
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tiotropium with fluticasone propionate/salmeterol (FSC)
COPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC)
tiotropium
COPD patients treated with tiotropium
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects diagnosed with COPD.
* Tobacco smoking 10 pack-years or more.
* Subjects with post-bronchodilator FEV1/FVC \< 0.7 and FEV1 \< 65% predicted.
Exclusion Criteria
* 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.
40 Years
80 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
The Korean Academy of Tuberculosis and Respiratory Diseases
OTHER
Responsible Party
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The Korean Academy of Tuberculosis and Respiratory Diseases
Principal Investigators
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Jee-Hong Yoo, Professor
Role: PRINCIPAL_INVESTIGATOR
East West Neo Medical Center
Sang-Do Lee, Professor
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Soonchunhyang University Bucheon Hospital
Bucheon-si, , South Korea
Inje university Pusan Paik hospital
Busan, , South Korea
Chonbuk national university hospital
Chunbuk, , South Korea
Keimyung university dongsan medical center
Daegu, , South Korea
Kyungpook national university hospital
Daegu, , South Korea
Yeungnam University Hospital
Daegu, , South Korea
Hallym University scared heart hospital
Gyeonggi-do, , South Korea
Gachon University Gil Hospital
Inchon, , South Korea
Incheon St. Mary's Hospital
Inchon, , South Korea
Inha university Hospital
Inchon, , South Korea
Gyeongsang national university hospital
Jinju, , South Korea
Chungbuk national university hospital
Jungbuk, , South Korea
Chungnam National University Hospital
Jungnam, , South Korea
Kyunghee university east-west neo medical center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Boramae Medical Center
Seoul, , South Korea
Ewha womans university mokdong hospital
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Inje university Seoul Paik Hospital
Seoul, , South Korea
Kangdong Scared heart Hospital
Seoul, , South Korea
Kangnam St. Mary's Hospital
Seoul, , South Korea
Konkuk university hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyunghee university medical center
Seoul, , South Korea
Samsung medical center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Soonchunhyang University hospital
Seoul, , South Korea
St. Paul's Hospital
Seoul, , South Korea
Ajou university hospital
Suwon, , South Korea
Uijeongbu St. Mary's Hospital
Uijeongbu-si, , South Korea
Wonju Christian Hospital
Wŏnju, , South Korea
Countries
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Other Identifiers
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112942
Identifier Type: -
Identifier Source: org_study_id