Health Condition 1: J454- Moderate persistent asthma
Conditions
Interventions
Intervention1: Inhaled Very low dose budesonide (100mcg) and formoterol (6mcg) combination: One arm will recieve 1 puff of Budesonide (100 mcg) + Formoterol (6 mcg), twice daily, by metered dose inhal
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children 6 to 11 years of age. 2. New physician diagnosed persistent asthma as per definition by GINA 2021 viz variable respiratory symptoms (wheeze, shortness of breath, chest tightness, cough with daytime symptoms >2 times/week, nocturnal symptoms >3- 4/month, use of SABA >2/week and documented variable expiratory airflow limitation with FEV1 less than 80% of predicted, FEV1/FVC ratio 20%). 3. Children eligible for medium dose inhaled corticosteroid therapy based on disease severity.
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed asthma already receiving inhaled corticosteroid in any form. 2. Children having a disease (other than asthma) that causes wheezing such as lower respiratory infections, or inhaled foreign body. 3. Children with known chronic respiratory disease (cystic fibrosis, primary ciliary dyskinesia), congenital heart disease. 4. Children with clinical features suggesting hepatic impairment. 5. Children having known seizure disorder, or type-1 diabetes. 6. Children with known autoimmune disease or immunodeficiency disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in PEFR (% of predicted) 4 weeks after the initiation of therapy (compared to baseline).Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Increase in PEFR (% of predicted) 8 weeks after the initiation of therapy (compared to baseline). 2. Increase in PEFR (% of predicted) 12 weeks after the initiation of therapy (compared to baseline). 3. PEFR (% of predicted) at 4 weeks, 8 weeks and 12 weeks of therapy. 4. Asthma symptom score at 4 weeks, 8 weeks and 12 weeks of therapy. 5. Adherence to therapy at 4 weeks, 8 weeks and 12 weeks of therapy. 6. Inhalation technique score at 4 weeks, 8 weeks and 12 weeks of therapy. 7. Solicited and unsolicited side effects 4 weeks, 8 weeks and 12 weeks of therapy. 8. Exacerbations requiring home or hospital treatment at 4 weeks, 8 weeks and 12 weeks of therapy. 9. Total number of extra doses of inhaled medication taken during therapy viz Budesonide-formoterol in group A; and Levo-salbutamol in group B, counted at 4 weeks, 8 weeks and 12 weeks of therapy. 10. Cost of therapy.Timepoint: 4 weeks, 8 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Annie Basson
PGIMER
Outcome results
None listed