Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea
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
1 other identifier
interventional
509
1 country
32
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 chronic-obstructive-pulmonary-disease
Started Mar 2009
Shorter than P25 for phase_4 chronic-obstructive-pulmonary-disease
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 17, 2009
CompletedFirst Posted
Study publicly available on registry
March 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedMarch 31, 2010
March 1, 2010
1 year
March 17, 2009
March 29, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in pre-dose FEV1 from baseline at 24 weeks after treatment
24 weeks
Secondary Outcomes (1)
Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety
24 weeks
Study Arms (2)
1
EXPERIMENTALtiotropium with fluticasone propionate/salmeterol (FSC)
2
ACTIVE COMPARATORtiotropium
Interventions
COPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
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, 134-727, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jee-Hong Yoo, Professor
East West Neo Medical Center
- PRINCIPAL INVESTIGATOR
Sang-Do Lee, Professor
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 17, 2009
First Posted
March 19, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
March 31, 2010
Record last verified: 2010-03