As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Hat Yai Medical Education Center
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Updated on 16 February 2024
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theophylline
corticosteroids
montelukast
eosinophil count
bronchodilator
budesonide
formoterol
spirometry
fractional exhaled nitric oxide
maintenance therapy

Summary

This study will evaluate the efficacy of as-needed Budesonide/formoterol Turbuhaler 160/4.5 g/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.

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.

Details
Condition Asthma, Asthma, Asthma (Pediatric), Allergies & Asthma, Asthma (Pediatric), Allergies & Asthma
Age 18years - 70years
Treatment Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder, Budesonide 200Mcg Inhalation Powder
Clinical Study IdentifierNCT04215848
SponsorHat Yai Medical Education Center
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 g/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
Patients who have FENO < 25 ppB and absoluted eosinophil count < 300 cell/mm3

Exclusion Criteria

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
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theophylline
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spirometry
fractional exhaled nitric oxide
maintenance therapy

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