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As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

Recruiting
18-70 years
All
Phase 3

Overview

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.

Eligibility

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

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

Study details
    Asthma
    Asthma
    Asthma (Pediatric)
    Allergies & Asthma
    Asthma (Pediatric)
    Allergies & Asthma

NCT04215848

Hat Yai Medical Education Center

16 February 2024

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