Efficacy of Once-daily Budesonide/Formoterol Turbuhaler 4.5/160 µg in Step Down Asthma

Hat Yai Medical Education Center77 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

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)

Budesonide (400μg/d)DRUG

After the patients who have all criteria, they will be randomization to take Budesonide (200 ug) twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Narongwit Nakwan

Hat Yai, Changwat Songkhla, Thailand

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: Baseline, week 4, week 8 and week 12

Secondary Outcomes

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.

Time frame: Baseline, week 4, week 8 and week 12

Change from baseline in Forced Expiratory Volume in One Second (FEV1)

The mean value for baseline and week 12 was analysed.

Time frame: Baseline and week 12

Percentage of participants who were categorized from asthma controlled assessment following GINA guideline

Time frame: Baseline, week 4, week 8 and week 12

Data from ClinicalTrials.gov

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