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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
The Korean Academy of Tuberculosis and Respiratory Diseases
ClinicalTrials.gov Identifier:
NCT00864812
First received: March 17, 2009
Last updated: March 29, 2010
Last verified: March 2010
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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 ]

Enrollment: 509
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
tiotropium with fluticasone propionate/salmeterol (FSC)
 Drug: tiotropium with fluticasone propionate/salmeterol (FSC)
COPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC)
Other Names:
  • tiotropium]:Spiriva
  • fluticasone propionate/salmeterol (FSC): Seretide
Active Comparator: 2
tiotropium
 Drug: tiotropium
COPD patients treated with tiotropium
Other Name: tiotropium: Spiriva

  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

Locations
Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Inje university Pusan Paik hospital
Busan, 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
Yeungnam University Hospital
Daegu, Korea, Republic of
Kyungpook national university hospital
Daegu, Korea, Republic of
Keimyung university dongsan medical center
Daegu, Korea, Republic of
Hallym University scared heart hospital
Gyeonggi-do, Korea, Republic of
Inha university Hospital
Inchon, Korea, Republic of
Gachon University Gil Hospital
Inchon, Korea, Republic of
Incheon St. Mary's Hospital
Inchon, Korea, Republic of
Gyeongsang national university hospital
Jinju, Korea, Republic of
Konkuk university hospital
Seoul, 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
Kyunghee university medical center
Seoul, Korea, Republic of
Kangdong Scared heart Hospital
Seoul, Korea, Republic of
Kangnam St. Mary's Hospital
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Kyunghee university east-west neo medical center
Seoul, Korea, Republic of, 134-727
Ewha womans university mokdong hospital
Seoul, Korea, Republic of
Boramae Medical Center
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Soonchunhyang University hospital
Seoul, Korea, Republic of
Inje university Seoul Paik Hospital
Seoul, Korea, Republic of
Ajou university hospital
Suwon, Korea, Republic of
Uijeongbu St. Mary's Hospital
Uijeongbu, Korea, Republic of
Wonju Christian Hospital
Wonju, Korea, Republic of
Sponsors and Collaborators
The Korean Academy of Tuberculosis and Respiratory Diseases
GlaxoSmithKline
Investigators
Principal Investigator: Jee-Hong Yoo, Professor East West Neo Medical Center
Principal Investigator: Sang-Do Lee, Professor Asan Medical Center
  More Information

No publications provided

Responsible Party: Sung-Koo, Han /Chairman, The Korean Academy of Tuberculosis and Respiratory Diseases
ClinicalTrials.gov Identifier: NCT00864812     History of Changes
Other Study ID Numbers: 112942
Study First Received: March 17, 2009
Last Updated: March 29, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Salmeterol
Fluticasone
Tiotropium
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 23, 2013