As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

Hat Yai Medical Education Center31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation PowderDRUG

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.

Budesonide 200Mcg Inhalation PowderDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hatyai Hospital

Hat Yai, Changwat Songkhla, Thailand

Outcomes

Primary Outcomes

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)

Time frame: 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.

Time frame: 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)

Time frame: 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

Time frame: The ratio of asthma controlled to total number of participants at week 24th-48th.

Secondary Outcomes

Change in lung function: FEV1%predicted

Change from baseline in FEV1%predicted

Time frame: 24-48 weeks.

Change in blood eosinophil count

The change of absoluted eosinophil count after step down medication

Time frame: 24-48 weeks.

Data from ClinicalTrials.gov

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