As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

Hat Yai Medical Education Center

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Budesonide 200Mcg Inhalation Powder

Drug: Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder

Study type

Interventional

Funder types

Other

Identifiers

NCT04215848

023/2562

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 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.

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