Clinical trial NCT04215848: As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period
Official title: A Pilot Study of Efficacy of As-needed Budesonide/Formoterol Turbuhaler During Stepping Down Period From Step-3 in Adult Patients With Adequately Controlled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma
allergy
Lead sponsor: Hat Yai Medical Education Center
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to First moderate/severe asthma exacerbation rate or loss of asthma controlled
timeFrame: Patients will be followed for first moderate/severe asthma exacerbation rate or loss of asthma controlled (an estimated average duration of 24-48 weeks)
measure: Time to First moderate/severe asthma exacarbation rate
timeFrame: Patients will be followed for first moderate/severe asthma exacerbation rate (an estimated average duration of 24-48 weeks)
measure: Time to First loss of asthma controlled
timeFrame: Patients will be followed for loss of asthma controlled (an estimated average duration of 24-48 weeks)
measure: The ratio of asthma controlled to total number of participants
timeFrame: The ratio of asthma controlled to total number of participants at week 24th-48th.
Secondary outcomes:
measure: Change in lung function: FEV1%predicted
timeFrame: 24-48 weeks.
measure: Change in blood eosinophil count
timeFrame: 24-48 weeks.
measure: Change in FENO
timeFrame: 48 weeks.
measure: Mean dose of inhaled steroid
timeFrame: 24-48 weeks.
measure: Change in lung function: Peak expiratory flow
timeFrame: 24-48 weeks.
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Hatyai Hospital
state: Songkhla
Study officials:
affiliation: HatYai Hospital
name: Narongwit Nakwan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: