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

Sponsor

The Korean Academy of Tuberculosis and Respiratory Diseases (Other)

Overall Status

Completed

CT.gov ID

NCT00864812

Collaborator

GlaxoSmithKline (Industry)

509

Enrollment

Locations

Arms

Duration (Months)

15.9

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: tiotropium with fluticasone propionate/salmeterol (FSC) Drug: tiotropium	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

509 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: tiotropium: Spiriva

Arm

Intervention/Treatment

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 Names:

tiotropium: Spiriva

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Soonchunhyang University Bucheon Hospital	Bucheon	Korea, Republic of
2	Inje university Pusan Paik hospital	Busan	Korea, Republic of
3	Chonbuk national university hospital	Chunbuk	Korea, Republic of
4	Chungbuk national university hospital	Chungbuk	Korea, Republic of
5	Chungnam National University Hospital	Chungnam	Korea, Republic of
6	Keimyung university dongsan medical center	Daegu	Korea, Republic of
7	Kyungpook national university hospital	Daegu	Korea, Republic of
8	Yeungnam University Hospital	Daegu	Korea, Republic of
9	Hallym University scared heart hospital	Gyeonggi-do	Korea, Republic of
10	Gachon University Gil Hospital	Inchon	Korea, Republic of
11	Incheon St. Mary's Hospital	Inchon	Korea, Republic of
12	Inha university Hospital	Inchon	Korea, Republic of
13	Gyeongsang national university hospital	Jinju	Korea, Republic of
14	Kyunghee university east-west neo medical center	Seoul	Korea, Republic of	134-727
15	Asan Medical Center	Seoul	Korea, Republic of
16	Boramae Medical Center	Seoul	Korea, Republic of
17	Ewha womans university mokdong hospital	Seoul	Korea, Republic of
18	Hanyang University Hospital	Seoul	Korea, Republic of
19	Inje university Seoul Paik Hospital	Seoul	Korea, Republic of
20	Kangdong Scared heart Hospital	Seoul	Korea, Republic of
21	Kangnam St. Mary's Hospital	Seoul	Korea, Republic of
22	Konkuk university hospital	Seoul	Korea, Republic of
23	Korea University Guro Hospital	Seoul	Korea, Republic of
24	Kyunghee university medical center	Seoul	Korea, Republic of
25	Samsung medical center	Seoul	Korea, Republic of
26	Seoul National University Hospital	Seoul	Korea, Republic of
27	Severance Hospital	Seoul	Korea, Republic of
28	Soonchunhyang University hospital	Seoul	Korea, Republic of
29	St. Paul's Hospital	Seoul	Korea, Republic of
30	Ajou university hospital	Suwon	Korea, Republic of
31	Uijeongbu St. Mary's Hospital	Uijeongbu	Korea, Republic of
32	Wonju Christian Hospital	Wonju	Korea, Republic of