Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea
Information source: The Korean Academy of Tuberculosis and Respiratory Diseases
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: tiotropium with fluticasone propionate/salmeterol (FSC) (Drug); tiotropium (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: The Korean Academy of Tuberculosis and Respiratory Diseases Official(s) and/or principal investigator(s):
Jee-Hong Yoo, Professor, Principal Investigator, Affiliation: Kyunghee university east-west neo medical center
Sang-Do Lee, Professor, Principal Investigator, Affiliation: Asan Medical Center
Overall contact:
Jee-Hong Yoo, Professor, Phone: 82-2-440-6117, Email: honglung@chol.com
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)
Clinical Details
Official 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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Changes in pre-dose FEV1 from baseline at 24 weeks after treatment
Secondary outcome: Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Jee-Hong Yoo, Professor, Phone: 82-2-440-6117, Email: honglung@chol.com
Kyunghee university east-west neo medical center, Seoul 134-727, Korea, Republic of
Asan Medical Center, Seoul, Korea, Republic of
Kangnam St. Mary's Hospital, Seoul, Korea, Republic of
Kangdong Scared heart Hospital, Seoul, Korea, Republic of
Konkuk university hospital, Seoul, Korea, Republic of
Hallym University scared heart hospital, Gyeonggi-do, Korea, Republic of
Kyungpook national university hospital, Daegu, Korea, Republic of
Gyeongsang national university hospital, Jinju, Korea, Republic of
Kyunghee university medical center, Seoul, Korea, Republic of
Keimyung university dongsan medical center, Daegu, Korea, Republic of
Korea University Guro Hospital, Seoul, Korea, Republic of
Boramae Medical Center, Seoul, Korea, Republic of
Inje university Pusan Paik hospital, Busan, Korea, Republic of
Soonchunhyang University Bucheon Hospital, Bucheon, Korea, Republic of
Samsung medical center, Seoul, Korea, Republic of
Seoul National University Hospital, Seoul, Korea, Republic of
Soonchunhyang University hospital, Seoul, Korea, Republic of
St. Paul's Hospital, Seoul, Korea, Republic of
Severance Hospital, Seoul, Korea, Republic of
Ajou university hospital, Suwon, Korea, Republic of
Yeungnam University Hospital, Daegu, Korea, Republic of
Wonju Christian Hospital, Wonju, Korea, Republic of
Uijeongbu St. Mary's Hospital, Uijeongbu, Korea, Republic of
Ewha womans university mokdong hospital, Seoul, Korea, Republic of
Gachon University Gil Hospital, Inchon, Korea, Republic of
Incheon St. Mary's Hospital, Inchon, Korea, Republic of
Inha university Hospital, Inchon, Korea, Republic of
Chungnam National University Hospital, Chungnam, Korea, Republic of
Chonbuk national university hospital, Chunbuk, Korea, Republic of
Inje university Seoul Paik Hospital, Seoul, Korea, Republic of
Chungbuk national university hospital, Chungbuk, Korea, Republic of
Hanyang University Hospital, Seoul, Korea, Republic of
Additional Information
Starting date: March 2009
Ending date: August 2011
Last updated: March 18, 2009
|
