As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period
- Conditions
- Asthma
- Interventions
- Drug: Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder
- Registration Number
- NCT04215848
- Lead Sponsor
- Hat Yai Medical Education Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- Patients who have been diagnosed as asthma at least 6 months.
- 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
- Patient who not be taking oral bronchodilator such as montelukast, theophylline, doxophylline but accept for taking anti histamine and intranasal steroid.
- Patients who able to do spirometry without contraindication.
- 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.
- History smoking less than 10 pack-years or be smoking
- History of asthma exacabation previous 12 week
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description As-needed Budesonide/Formoterol Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder As-needed Budesonide/Formoterol (160/4.5 ug) Budesonide Budesonide 200Mcg Inhalation Powder Budesonide (200 ug) twice daily
- Primary Outcome Measures
Name Time Method 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
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)
- Secondary Outcome Measures
Name Time Method Change in lung function: Peak expiratory flow 24-48 weeks. Change from baseline in Peak expiratory flow
Change in lung function: FEV1%predicted 24-48 weeks. Change from baseline in FEV1%predicted
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
Trial Locations
- Locations (1)
Hatyai Hospital
🇹🇭Hat Yai, Songkhla, Thailand