Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea

This study is not yet open for participant recruitment.

Verified by The Korean Academy of Tuberculosis and Respiratory Diseases, March 2009

First Received: March 17, 2009 Last Updated: March 18, 2009 History of Changes

Sponsor:	The Korean Academy of Tuberculosis and Respiratory Diseases
Collaborator:	GlaxoSmithKline
Information provided by:	The Korean Academy of Tuberculosis and Respiratory Diseases
ClinicalTrials.gov Identifier:	NCT00864812

Purpose

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)

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: tiotropium with fluticasone propionate/salmeterol (FSC) Drug: tiotropium	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Tiotropium bromide Tiotropium

U.S. FDA Resources

Further study details as provided by The Korean Academy of Tuberculosis and Respiratory Diseases:

Primary Outcome Measures:

Changes in pre-dose FEV1 from baseline at 24 weeks after treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	466
Study Start Date:	March 2009
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental tiotropium with fluticasone propionate/salmeterol (FSC)	Drug: tiotropium with fluticasone propionate/salmeterol (FSC) COPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC)
2: Active Comparator tiotropium	Drug: tiotropium COPD patients treated with tiotropium

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864812

Contacts

Contact: Jee-Hong Yoo, Professor	82-2-440-6117	honglung@chol.com
Contact: Sang-Do Lee, Professor	82-2-3010-3140	sdlee@www.amc.seoul.kr

Locations

Korea, Republic of
Kyunghee university east-west neo medical center
Seoul, Korea, Republic of, 134-727
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
Hanyang 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
Soonchunhyang University hospital
Seoul, Korea, Republic of

Sponsors and Collaborators

The Korean Academy of Tuberculosis and Respiratory Diseases

GlaxoSmithKline

Investigators

Principal Investigator:	Jee-Hong Yoo, Professor	Kyunghee university east-west neo medical center
Principal Investigator:	Sang-Do Lee, Professor	Asan Medical Center

More Information

No publications provided

Responsible Party:	The Korean Academy of Tuberculosis and Respiratory Diseases ( Sung-Koo, Han /Chairman )
Study ID Numbers:	112942
Study First Received:	March 17, 2009
Last Updated:	March 18, 2009
ClinicalTrials.gov Identifier:	NCT00864812 History of Changes
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Cholinergic Agents
Adrenergic Agonists
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone

Tiotropium
Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Respiration Disorders
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010