Severe asthma attack in child Severe asthma attack MART Fixed dose ICS/LABA
Conditions
Interventions
A single ICS/LABA inhaler (e.g., budesonide/formoterol) is used at a regular maintenance dose and additionally used as-needed for symptom relief.,Patients take a fixed, regular dose of a combination i
Experimental Drug,Experimental Drug
Group A: MART (ICS/LABA used as both maintenance and reliever),Group B: Fixed dose ICS/LABA
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Children aged 6 to18 years 2.Diagnosed with asthma according to GINA guideline 2025 3.Hospitalized for a severe asthma exacerbation 4.Planned to continue controller therapy with inhaled ICS/LABA after discharge
Exclusion criteria
Exclusion criteria: 1.Other chronic lung diseases such as cystic fibrosis, bronchiectasis, or bronchiolitis obliterans Unstable cardiac disease or other comorbidities affecting spirometry (e.g., neuromuscular disease, thoracic cage deformity) 2.History of allergy to or contraindication for budesonide, formoterol, or any inhaler components 3.Unable to attend clinic visits or follow-up as scheduled 4.Participation in other interventional research that could affect asthma control during the same period 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Childhood asthma control test/asthma control test scores baseline to months 1, 3, and 6 Mean change in Childhood asthma control test/asthma control test scores from baseline at months 1, 3, and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of asthma exacerbations requiring systemic corticosteroids From discharge (baseline) to 6 months. Proportion of patients experiencing more than one exacerbation requiring systemic corticosteroids,Number of reliever puffs per day From discharge (baseline) to 6 months. verage daily number of reliever puffs (puffs/day) per patient.,Change in FEV1 (% predicted) and FeNO from baseline baseline to months 1, 3, and 6 Change in FEV1 expressed as % predicted and Change in fractional exhaled nitric oxide,Adverse events From discharge (baseline) to 6 months. Incidence: number and proportion (%) of participants with more than one AE | — |
Countries
Thailand
Contacts
Public ContactPhattharat Chursuwan
Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed