Health Condition 1: J454- Moderate persistent asthma
Conditions
Interventions
Intervention1: Inhaled low-dose Budesonide/Formoterol combination: 1 puff of Budesonide (100 mcg) + Formoterol (6 mcg), twice daily, by metered dose inhaler through a spacer
Control Intervention1: Med
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1) Children 6 to 12 years of age 2) New physician diagnosed persistent asthma as per definition by GINA 2019 ( variable respiratory symptoms such as 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 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 tract infections or inhaled foreign body 3) Children with known respiratory disease ( cystic fibrosis, primary ciliary dyskinesia) 4) Children with clinical features suggesting hepatic impairment 5) Children having known seizure disorder, Type-1 DM 6) children with known autoimmune and immunodeficiency disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in PEFR (%) 4 weeks after initiation of therapy (compared to baseline)Timepoint: Increase in PEFR (%) 4 weeks after initiation of therapy (compared to baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Increase in PEFR (%) 8 weeks after initiation of therapy 2) Increase in PEFR (%) 12 weeks after initiation of therapy 3) PEFR (%) at 4, 8 and 12 weeks of therapy 4) Asthma symptoms score at 4, 8 and 12 weeks of therapy 5) Solicited and unsolicited side effects at 4, 8 and 12 weeks of therapy 6) Exacerbations requiring home or hospital treatment at 4, 8 and 12 weeks of therapy 7) Total dosage of inhaled steroid plus oral steroid consumed at 4, 8 and 12 weeks of therapy Timepoint: At 4, 8 and 12 weeks of therapy | — |
Countries
India
Contacts
Public ContactHimasnhu Gupta
PGIMER Chandigarh
Outcome results
None listed