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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once-daily budesonide/formoterol (160/4.5 μg/d) | Experimental | once-daily budesonide/formoterol (160/4.5 μg/d) |
|
| Twice-daily Budesonide (200μg) | Active Comparator | twice-daily Budesonide (400μg/d) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol (160/4.5 μg/d) | Drug | After the patients who have all criteria, they will be randomization to take Budesonide/formoterol (160/4.5 μg/d) |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narongwit Nakwan, M.D. | HatYai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Narongwit Nakwan | Hat Yai | Changwat Songkhla | 90110 | Thailand |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Budesonide (400μg/d) | Drug | After the patients who have all criteria, they will be randomization to take Budesonide (200 ug) twice daily |
|
|
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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |