Comparison of Anti-inflammatory Effects of Seroflo and Seretide in Patients With Asthma

Study Overview
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Brief Summary
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The purpose of this study is to test hypothesis if Sereflo (ICS/LABA) could reduce airway inflammation in asthmatic patients in the same as Seretide.

Official Title
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Comparison of Anti-inflammatory Effects of Seroflo 125 Inhaler With Seretide Evohaler(25/125) in Patients With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Sereflo
* Drug: Seretide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20-80 years Patients with asthma diagnosed by according to the American Thoracic Society criteria A baseline FEV1 > or = 50% predicted with a reversibility of FEV1 after therapy with inhaled salbuterol (2.5 mg) of FEV1 12% or with provocative concentration of a methacholine causing a 20% fall in FEV1 (PC20) of < or = 8 mg/mL Prescribed use of inhaled corticosteroids (any brand) for at least 12 weeks prior to study entry The daily prescribed dose of inhaled corticosteroids during the last 4 weeks prior to study entry should have been constant and at least 250 μg/day of fluticasone at least 400 μg/day of budesonide at least 500 μg/day of any other beclomethasone Be able to provide written informed consent Exclusion Criteria: Any asthma exacerbation or respiratory tract infection affecting asthma within 4 weeks prior to the randomization visit Intake of oral, parenteral corticosteroids within 4 weeks and/or depot parenteral corticosteroid within 12 weeks prior to the randomization visits Current or previous smoker with a smoking history of > or = 10 pack years Previous randomization of treatment in the present study Known or suspected hypersensitivity to study therapy Use of any β-blocking agent, including eye-drops Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive pill measures

Ages Eligible for Study
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Minimum Age: 18 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sereflo<br>Sereflo (25/125) | Drug: Sereflo<br>* Patients take sereflo (25/125) 2 puffs twice a day for 4 weeks<br>|
| Active Comparator: Seretide<br>Seretide (25/125) | Drug: Seretide<br>* Patients will take Seretide (25/125) 2 puffs twice a day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum eosinophils |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled nitric oxide |  | 4 weeks | 
| Asthma control test scores |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma