Health Condition 1: J455- Severe persistent asthma
Conditions
Interventions
Intervention1: Budesonide: Inhaled Budesonide (with spacer + mask) 100 microgram 2 puff twice a day during wheezing episodes (7 to 14 days) for 3 months.
Control Intervention1: Budesonide: Inhaled Bud
Sponsors
All India Institute of Medical Science AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 1)= Three episodes of Wheezing/year 2)Symptoms (Cough, wheeze, difficulty in breathing) for >7-10 days during upper respiratory tract infections 3)Between the episodes have cough, wheeze, or heavy breathing (occasional or during play/laughing) 4)Allergic sensitization or atopic dermatitis or food allergy or family history of asthma. (According to GINA guidelines 2022)
Exclusion criteria
Exclusion criteria: 1)Children requiring Pediatric Intensive Care Unit admission due to wheezing 2)Children with = 2 In-Patient admission or > 3 times Oral corticosteroid administration for wheezing in the past 1 year 3)Children with other co-morbidities such as Gastro-esophageal reflux disease 4)Children with other chronic lung diseases- Cystic fibrosis, Primary ciliary dyskinesia, prematurity,etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Test for Respiratory and Asthma Control in Kids (TRACK) score in children on Intermittent inhaled budesonide therapy in comparison to daily inhaled budesonide therapy.Timepoint: Baseline, First month, Second month, Third month. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the frequency of wheezing exacerbation requiring oral glucocorticoids/emergency visit/Hospitalizations 2. Proportion of episode-free days in both the groups 3. Cumulative dose of ICS used between both the groups 4. Frequency of adverse effects between both the groups Timepoint: baseline 1st month second month third month | — |
Countries
India
Contacts
Public ContactKalyanaprabhakaran B
AIIMS, Jodhpur
Outcome results
None listed