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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tiotropium with fluticasone propionate/salmeterol (FSC)
tiotropium
Sponsored by
The Korean Academy of Tuberculosis and Respiratory Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Soonchunhyang University Bucheon Hospital
  • Inje university Pusan Paik hospital
  • Chonbuk national university hospital
  • Chungbuk national university hospital
  • Chungnam National University Hospital
  • Keimyung university dongsan medical center
  • Kyungpook national university hospital
  • Yeungnam University Hospital
  • Hallym University scared heart hospital
  • Gachon University Gil Hospital
  • Incheon St. Mary's Hospital
  • Inha university Hospital
  • Gyeongsang national university hospital
  • Kyunghee university east-west neo medical center
  • Asan Medical Center
  • Boramae Medical Center
  • Ewha womans university mokdong hospital
  • Hanyang University Hospital
  • Inje university Seoul Paik Hospital
  • Kangdong Scared heart Hospital
  • Kangnam St. Mary's Hospital
  • Konkuk university hospital
  • Korea University Guro Hospital
  • Kyunghee university medical center
  • Samsung medical center
  • Seoul National University Hospital
  • Severance Hospital
  • Soonchunhyang University hospital
  • St. Paul's Hospital
  • Ajou university hospital
  • Uijeongbu St. Mary's Hospital
  • Wonju Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

tiotropium with fluticasone propionate/salmeterol (FSC)

tiotropium

Outcomes

Primary Outcome Measures

Changes in pre-dose FEV1 from baseline at 24 weeks after treatment

Secondary Outcome Measures

Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety

Full Information

First Posted
March 17, 2009
Last Updated
March 29, 2010
Sponsor
The Korean Academy of Tuberculosis and Respiratory Diseases
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00864812
Brief Title
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

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Korean Academy of Tuberculosis and Respiratory Diseases
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
509 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
tiotropium with fluticasone propionate/salmeterol (FSC)
Arm Title
2
Arm Type
Active Comparator
Arm Description
tiotropium
Intervention Type
Drug
Intervention Name(s)
tiotropium with fluticasone propionate/salmeterol (FSC)
Other Intervention Name(s)
tiotropium]:Spiriva, fluticasone propionate/salmeterol (FSC): Seretide
Intervention Description
COPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC)
Intervention Type
Drug
Intervention Name(s)
tiotropium
Other Intervention Name(s)
tiotropium: Spiriva
Intervention Description
COPD patients treated with tiotropium
Primary Outcome Measure Information:
Title
Changes in pre-dose FEV1 from baseline at 24 weeks after treatment
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jee-Hong Yoo, Professor
Organizational Affiliation
East West Neo Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang-Do Lee, Professor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Inje university Pusan Paik hospital
City
Busan
Country
Korea, Republic of
Facility Name
Chonbuk national university hospital
City
Chunbuk
Country
Korea, Republic of
Facility Name
Chungbuk national university hospital
City
Chungbuk
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Chungnam
Country
Korea, Republic of
Facility Name
Keimyung university dongsan medical center
City
Daegu
Country
Korea, Republic of
Facility Name
Kyungpook national university hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Hallym University scared heart hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Inchon
Country
Korea, Republic of
Facility Name
Incheon St. Mary's Hospital
City
Inchon
Country
Korea, Republic of
Facility Name
Inha university Hospital
City
Inchon
Country
Korea, Republic of
Facility Name
Gyeongsang national university hospital
City
Jinju
Country
Korea, Republic of
Facility Name
Kyunghee university east-west neo medical center
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha womans university mokdong hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hanyang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Inje university Seoul Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangdong Scared heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangnam St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk university hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyunghee university medical center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung medical center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Soonchunhyang University hospital
City
Seoul
Country
Korea, Republic of
Facility Name
St. Paul's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou university hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Uijeongbu St. Mary's Hospital
City
Uijeongbu
Country
Korea, Republic of
Facility Name
Wonju Christian Hospital
City
Wonju
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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