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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: tiotropium with fluticasone propionate/salmeterol (FSC)
* Drug: tiotropium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>tiotropium with fluticasone propionate/salmeterol (FSC) | Drug: tiotropium with fluticasone propionate/salmeterol (FSC)<br>* COPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC)<br>* Other names: fluticasone propionate/salmeterol (FSC): Seretide;|
| Active Comparator: 2<br>tiotropium | Drug: tiotropium<br>* COPD patients treated with tiotropium<br>* Other names: tiotropium: Spiriva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pre-dose FEV1 from baseline at 24 weeks after treatment |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety |  | 24 weeks |