Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT00864812
- Lead Sponsor
- The Korean Academy of Tuberculosis and Respiratory Diseases
- 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
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 509
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 tiotropium with fluticasone propionate/salmeterol (FSC) tiotropium with fluticasone propionate/salmeterol (FSC) 2 tiotropium tiotropium
- Primary Outcome Measures
Name Time Method Changes in pre-dose FEV1 from baseline at 24 weeks after treatment 24 weeks
- Secondary Outcome Measures
Name Time Method Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety 24 weeks
Trial Locations
- Locations (32)
Kyunghee university medical center
🇰🇷Seoul, Korea, Republic of
Inje university Pusan Paik hospital
🇰🇷Busan, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
Chonbuk national university hospital
🇰🇷Chunbuk, Korea, Republic of
Chungbuk national university hospital
🇰🇷Chungbuk, Korea, Republic of
Chungnam National University Hospital
🇰🇷Chungnam, Korea, Republic of
Keimyung university dongsan medical center
🇰🇷Daegu, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Inchon, Korea, Republic of
Inha university Hospital
🇰🇷Inchon, Korea, Republic of
Kyungpook national university hospital
🇰🇷Daegu, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Inje university Seoul Paik Hospital
🇰🇷Seoul, Korea, Republic of
Kyunghee university east-west neo medical center
🇰🇷Seoul, Korea, Republic of
Ewha womans university mokdong hospital
🇰🇷Seoul, Korea, Republic of
Kangdong Scared heart Hospital
🇰🇷Seoul, Korea, Republic of
Kangnam St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk university hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Samsung medical center
🇰🇷Seoul, Korea, Republic of
Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
Ajou university hospital
🇰🇷Suwon, Korea, Republic of
Wonju Christian Hospital
🇰🇷Wonju, Korea, Republic of
Hallym University scared heart hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
St. Paul's Hospital
🇰🇷Seoul, Korea, Republic of
Incheon St. Mary's Hospital
🇰🇷Inchon, Korea, Republic of
Gyeongsang national university hospital
🇰🇷Jinju, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of