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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| As-needed Budesonide/Formoterol | Experimental | As-needed Budesonide/Formoterol (160/4.5 ug) |
|
| Budesonide | Active Comparator | Budesonide (200 ug) twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder | Drug | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narongwit Nakwan, M.D. | HatYai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hatyai Hospital | Hat Yai | Changwat Songkhla | 90110 | Thailand |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| 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 200Mcg Inhalation Powder | Drug | After the patients who have all criteria, they will be randomized to take Budesonide (200 μg) twice daily |
|
|
| 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. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| 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 |