Comparing Treatment Efficacy With HD/MD Flu Plus Sal in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
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Brief Summary
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Chronic obstructive pulmonary disease is characterized as inflammatory airway with not fully reversible airflow limitation.Combination treatment with inhaled corticosteroid (ICS) and long-acting β2 agonists (LABA)attains an improved control of symptoms and lung function, that are superior to those associated with either drug alone. However, the treatment efficacy between high and medium dose of inhaled corticosteroid in combination of LABA is still unknown. The aim of the current study is to investigate the treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.

Detailed Description
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Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and the use of health care resources worldwide. It is characterized by chronic progressive symptoms, airflow obstruction, and impaired health status, which is worse in those who have frequent, acute episodes of symptom exacerbation. Treatment for COPD is focused on minimizing risk factors, improving symptoms, and preventing exacerbations. Pulmonary inflammation is the key factor in COPD. Inhaled long-acting β2 agonists (LABA) improve airflow obstruction, control of symptoms, and health status in patients with COPD over 3 to 4 months. Inhaled corticosteroids (ICS) are currently the most popular anti-inflammatory medications for use in symptomatic patients with COPD. Previous large scaled randomized control study discovered long-term use of ICS didn't modified annual decline of lung function in COPD patients, but may reduce the frequency of exacerbations, especially when combined with an LABA. Combination treatment with ICS and LABA has been widely used for patients with COPD and attains an improved control of symptoms and lung function, with no greater risk of side-effects than that of treatment with either component alone. Combined ICS/LABA will result in better treatment effects that are superior to those associated with either drug alone. However, the treatment efficacy between high and medium dose of inhaled corticosteroid in combination of LABA is still unknown. The aim of the current study is to investigate the treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: fluticasone/ salmeterol 125/25 mcg/puff
* Drug: fluticasone/ salmeterol 250/25 mcg/puff


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 specified procedures.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Comparator: MD Flu/Sal<br>fluticasone125 mcg/ salmeterol 25 mcg 2puffs (medium dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis. | Drug: fluticasone/ salmeterol 125/25 mcg/puff<br>* fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks<br>* Other names: Seretide evohaler 125(GlaxoSmithKline);|
| Experimental: HD Flu/Sal<br>fluticasone 250 mcg/salmeterol 25 mcg 2puffs (high dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis. | Drug: fluticasone/ salmeterol 250/25 mcg/puff<br>* fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks<br>* Other names: Seretide evohaler 250(GlaxoSmithKline);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of lung function parameters(FEV1&FVC) at different time points | The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), at different time points, including baseline, 12th week, 28th week, and ending (52th week). | baseline, week 12, 28 and 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual rate of acute exacerbations | total numbers of acute exacerbation throughout the study year | 1 year | 
| Life quality evaluation | The changes of Health-related quality of life assessed by CAT questionnaire before and after treatment. | baseline, week 12, 28, and 52 | 
| Annual incidence of community-acquired pneumonia | Annual incidence of community-acquired pneumonia throughout the study year | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic obstructive pulmonary disease, lung function change FEV1 FVC, acute exacerbation, life quality questionnaire