As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

Study Overview
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Brief Summary
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This study will evaluate the efficacy of as-needed Budesonide/formoterol Turbuhaler 160/4.5 µg/d in the period of step down in well controlled asthmatic patient comparing with standard maintenance therapy in step-2 management in asthma guildeline which is low dose inhaled corticosteroid.

Detailed Description
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The study will measure the efficacy of as-needed low dose ICS/ LABA in well controlled asthmatic patient comparing with low dose ICS in step down circumstance.

Official Title
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A Pilot Study of Efficacy of As-needed Budesonide/Formoterol Turbuhaler During Stepping Down Period From Step-3 in Adult Patients With Adequately Controlled Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder
* Drug: Budesonide 200Mcg Inhalation Powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been diagnosed as asthma at least 6 months. Patients who have well controlled asthma by ACT > 23 and ACQ-7 < 0.75 at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily Patient who not be taking oral bronchodilator such as montelukast, theophylline, doxophylline but accept for taking anti histamine and intranasal steroid. Patients who able to do spirometry without contraindication. Exclusion Criteria: History of using systemic steroid previous 12 week and respiratory infection History of pulmonary tuberculosis with residual lung lesion by chest radiograph recent serious medical condition such as myocardial infarction, stroke, pneumonia etc. History smoking less than 10 pack-years or be smoking History of asthma exacabation previous 12 week

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: As-needed Budesonide/Formoterol<br>As-needed Budesonide/Formoterol (160/4.5 ug) | Drug: Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder<br>* After the patients who have all criteria, they will be randomized to take Budesonide/formoterol (160/4.5 μg/d) as need when they have symptoms.<br>* Other names: Symbicort Turbuhaler (160/4.5 ug);|
| Active Comparator: Budesonide<br>Budesonide (200 ug) twice daily | Drug: Budesonide 200Mcg Inhalation Powder<br>* After the patients who have all criteria, they will be randomized to take Budesonide (200 μg) twice daily<br>* Other names: Pulmicort Turbuhaler (200 ug);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First moderate/severe asthma exacerbation rate or loss of asthma controlled | Duration after the patients who has been randomised to developed asthma exacerbation or loss of asthma control that evaluation by Asthma Controlled Test (ACT) | Patients will be followed for first moderate/severe asthma exacerbation rate or loss of asthma controlled (an estimated average duration of 24-48 weeks) | 
| Time to First moderate/severe asthma exacarbation rate | Duration after randomisation until the patients will develop asthma exacerbation. | Patients will be followed for first moderate/severe asthma exacerbation rate (an estimated average duration of 24-48 weeks) | 
| Time to First loss of asthma controlled | Duration after randomisation until the patients will have a loss of asthma control evaluating by Asthma Controlled Test (ACT) | Patients will be followed for loss of asthma controlled (an estimated average duration of 24-48 weeks) | 
| The ratio of asthma controlled to total number of participants | The ratio of participants who will be classified for asthma controlled to total number of participants by ACT score | The ratio of asthma controlled to total number of participants at week 24th-48th. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function: FEV1%predicted | Change from baseline in FEV1%predicted | 24-48 weeks. | 
| Change in blood eosinophil count | The change of absoluted eosinophil count after step down medication | 24-48 weeks. | 
| Change in FENO | The change of FENO after step down medication | 48 weeks. | 
| Mean dose of inhaled steroid | The amount of inhaled steroid dose throughout the study | 24-48 weeks. | 
| Change in lung function: Peak expiratory flow | Change from baseline in Peak expiratory flow | 24-48 weeks. | 

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