Asthma
Conditions
Brief summary
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
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.
Interventions
DRUGBudesonide/formoterol (160/4.5 μg/d)
After the patients who have all criteria, they will be randomization to take Budesonide/formoterol (160/4.5 μg/d)
After the patients who have all criteria, they will be randomization to take Budesonide (200 ug) 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 No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Asthma Control Questionnaire (ACQ) score | Baseline and week 12 | 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). |
| Change from baseline in Asthma Controlled Test (ACT) score | Baseline, week 4, week 8 and week 12 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Peak expiratory flow (PEF) | Baseline, week 4, week 8 and week 12 | The mean value of PEF (Litre per minute) for baseline, week 4, 8 and 12 was analysed. |
| Change from baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline and week 12 | The mean value for baseline and week 12 was analysed. |
| Percentage of participants who were categorized from asthma controlled assessment following GINA guideline | Baseline, week 4, week 8 and week 12 | — |
Countries
Thailand
Outcome results
None listed