Asthma
Conditions
Keywords
asthma, allergy
Brief summary
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
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.
Interventions
DRUGBudesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder
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.
DRUGBudesonide 200Mcg Inhalation Powder
After the patients who have all criteria, they will be randomized to take Budesonide (200 μg) twice daily
Sponsors
Hat Yai Medical Education Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who have been diagnosed as asthma at least 6 months. 2. 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 3. Patient who not be taking oral bronchodilator such as montelukast, theophylline, doxophylline but accept for taking anti histamine and intranasal steroid. 4. Patients who able to do spirometry without contraindication.
Exclusion criteria
1. 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. 2. History smoking less than 10 pack-years or be smoking 3. History of asthma exacabation previous 12 week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First moderate/severe asthma exacerbation rate or loss of asthma controlled | Patients will be followed for first moderate/severe asthma exacerbation rate or loss of asthma controlled (an estimated average duration of 24-48 weeks) | Duration after the patients who has been randomised to developed asthma exacerbation or loss of asthma control that evaluation by Asthma Controlled Test (ACT) |
| Time to First moderate/severe asthma exacarbation rate | Patients will be followed for first moderate/severe asthma exacerbation rate (an estimated average duration of 24-48 weeks) | Duration after randomisation until the patients will develop asthma exacerbation. |
| Time to First loss of asthma controlled | Patients will be followed for loss of asthma controlled (an estimated average duration of 24-48 weeks) | Duration after randomisation until the patients will have a loss of asthma control evaluating by Asthma Controlled Test (ACT) |
| The ratio of asthma controlled to total number of participants | The ratio of asthma controlled to total number of participants at week 24th-48th. | The ratio of participants who will be classified for asthma controlled to total number of participants by ACT score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in lung function: FEV1%predicted | 24-48 weeks. | Change from baseline in FEV1%predicted |
| Change in lung function: Peak expiratory flow | 24-48 weeks. | Change from baseline in Peak expiratory flow |
| Change in blood eosinophil count | 24-48 weeks. | The change of absoluted eosinophil count after step down medication |
| Change in FENO | 48 weeks. | The change of FENO after step down medication |
| Mean dose of inhaled steroid | 24-48 weeks. | The amount of inhaled steroid dose throughout the study |
Countries
Thailand
Outcome results
None listed