Clinical trial NCT00864812: Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: The Korean Academy of Tuberculosis and Respiratory Diseases
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-03-19
Enrollment: 509
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility 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.

Primary outcomes:
measure: Changes in pre-dose FEV1 from baseline at 24 weeks after treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Inje university Pusan Paik hospital
city: Chunbuk
country: Korea, Republic of
facility: Chonbuk national university hospital
city: Chungbuk
country: Korea, Republic of
facility: Chungbuk national university hospital
city: Chungnam
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung university dongsan medical center
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University scared heart hospital
city: Inchon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Inchon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital
city: Inchon
country: Korea, Republic of
facility: Inha university Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang national university hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee university east-west neo medical center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha womans university mokdong hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Inje university Seoul Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Scared heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk university hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee university medical center
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University hospital
city: Seoul
country: Korea, Republic of
facility: St. Paul's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou university hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
Study officials:
affiliation: East West Neo Medical Center
name: Jee-Hong Yoo, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Sang-Do Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References: