Efficacy of Once-daily Budesonide/Formoterol Turbuhaler 4.5/160 µg in Step Down Asthma

Study Overview
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Brief Summary
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This study will evaluate the efficacy of Once-daily Budesonide/formoterol Turbuhaler 160/4.5 µg/d in the period of step down in well controlled asthmatic patient.

Detailed Description
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The study will measure the efficacy of once daily 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 12-week, Randomized, Parallel-group, Phase III Study Comparing the Efficacy of Once-daily Budesonide/Formoterol Turbuhaler (160/4.5 μg/d) and Twice-daily Budesonide Giona Easyhaler (400 μg/d) During Step-down Period in Well Controlled Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide/formoterol (160/4.5 μg/d)
* Drug: Budesonide (400μg/d)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asthmatic patients who have well controlled asthma at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily Age more than 18 year-old Patients who able to do spirometry without contraindication History smoking less than 10 pack-years Exclusion Criteria: History of using systemic steroid previous 4 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.

Ages Eligible for Study
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Minimum Age: 18 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: Once-daily budesonide/formoterol (160/4.5 μg/d)<br>once-daily budesonide/formoterol (160/4.5 μg/d) | Drug: Budesonide/formoterol (160/4.5 μg/d)<br>* After the patients who have all criteria, they will be randomization to take Budesonide/formoterol (160/4.5 μg/d)<br>* Other names: Symbicort Turbuhaler (160/4.5 μg/d);|
| Active Comparator: Twice-daily Budesonide (200μg)<br>twice-daily Budesonide (400μg/d) | Drug: Budesonide (400μg/d)<br>* After the patients who have all criteria, they will be randomization to take Budesonide (200 ug) twice daily<br>* Other names: Giona Easyhaler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Asthma Control Questionnaire (ACQ) score | Asthma Control Questionnaire (ACQ) that is 6 items of self-administered and 1 item of FEV1%. It has 7-point scale (=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Scores range between 0 (totally controlled) and 6 (severely uncontrolled). | Baseline and week 12 | 
| Change from baseline in Asthma Controlled Test (ACT) score | 1. Asthma Controlled Test (ACT); grouped in five domains; frequency of shortness of breath, general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma | Baseline, week 4, week 8 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Peak expiratory flow (PEF) | The mean value of PEF (Litre per minute) for baseline, week 4, 8 and 12 was analysed. | Baseline, week 4, week 8 and week 12 | 
| Change from baseline in Forced Expiratory Volume in One Second (FEV1) | The mean value for baseline and week 12 was analysed. | Baseline and week 12 | 
| Percentage of participants who were categorized from asthma controlled assessment following GINA guideline |  | Baseline, week 4, week 8 and week 12 |