Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients

Study Overview
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Brief Summary
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This study is to investigate and compare treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.

Detailed Description
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Diagnosis and criteria for inclusion and exclusion: Inclusion: Male or female outpatients aged 40 years≧ Current or ex-smoker, with smoking history 10 pack≧- years COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator) Exclusion: Diagnosis or suspicion of sleep apnea. Concurrent rhinitis, eczema, and asthma. Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease. A chest X-ray indicating diagnosis other than COPD that might interfere with the study. Major disease abnormalities are uncontrolled on therapy. Alcohol or medication abuse. Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study. Unable or unwilling to comply with all protocol Test product: fluticasone125 mcg/salmetrol 25 mcg ( Seretide 125 Evohaler ) fluticasone250 mcg/salmetrol 25 mcg ( Seretide 250 Evohaler ) Formulation: fluticasone/salmeterol, 125/25 mcg/puff Dose: 2 puffs bid

Conditions
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Quality of Life, Percentage of Annual Acute Exacerbation

Intervention / Treatment
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* Drug: Fluticasone/Salmeterol high dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients aged 40 years≧ Current or ex-smoker, with smoking history 10 pack≧- years COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator) Exclusion Criteria: Diagnosis or suspicion of sleep apnea. Concurrent rhinitis, eczema, and asthma. Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease. A chest X-ray indicating diagnosis other than COPD that might interfere with the study. Major disease abnormalities are uncontrolled on therapy. Alcohol or medication abuse. Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study. Unable or unwilling to comply with all protocol

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: Fluticasone/salmeterol high dose<br>COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day) | Drug: Fluticasone/Salmeterol high dose<br> <br> * Other names: COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day);|
| Active Comparator: Fluticasone/Salmeterol medium dose<br>COPD patients treating with medium dose of ICS (Fluticasone 500ug/day) combined with Salmeterol (25ug/day) | Drug: Fluticasone/Salmeterol high dose<br> <br> * Other names: COPD patients treating with high dose of ICS (Fluticasone 1000ug/day) combined with Salmeterol (25ug/day);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), before and after treatment. | We will compare the lung function changed in COPD patients treating with different doses of Fluticasone (500 and 1000ug) | Lung function change in one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual rate of acute exacerbations | Annual rate of acute exacerbations The number of use of rescue medication Annual incidence of community-acquired pneumonia The changes of Health-related quality of life assessed by questionnaire (CAT or SGRQ) before and after treatment. | percentage of acute exacerbation in one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Fluticasone/Salmeterol, high dose