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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
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.
Details
| Lead sponsor | Hat Yai Medical Education Center |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 77 |
| Start date | 2016-03 |
| Completion | 2016-12 |
Conditions
- Asthma
Interventions
- Budesonide/formoterol (160/4.5 μg/d)
- Budesonide (400μg/d)
Primary outcomes
- 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
Countries
Thailand