A trial to compare Single Maintenance and Reliever Therapy(SMART) with single inhaler containing Budesonide-Formoterol combination versus the conventionally used 2 inhaler treatment with Budesonide and additional as needed Levo-salbutamol in children with Persistent Bronchial Asthma

Phase 3

Conditions: Health Condition 1: J454- Moderate persistent asthma

Registration Number: CTRI/2022/07/043723

Lead Sponsor: PGIMER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 <80%, or PEFR variability >20%).

3. Children eligible for medium dose inhaled corticosteroid therapy based on disease severity.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in PEFR (% of predicted) 4 weeks after the initiation of therapy (compared to baseline).Timepoint: 4 weeks

Secondary Outcome Measures

Name	Time	Method
1. Increase in PEFR (% of predicted) 8 weeks after the initiation of therapy (compared to baseline). <br/ ><br>2. Increase in PEFR (% of predicted) 12 weeks after the initiation of therapy (compared to baseline). <br/ ><br>3. PEFR (% of predicted) at 4 weeks, 8 weeks and 12 weeks of therapy. <br/ ><br>4. Asthma symptom score at 4 weeks, 8 weeks and 12 weeks of therapy. <br/ ><br>5. Adherence to therapy at 4 weeks, 8 weeks and 12 weeks of therapy. <br/ ><br>6. Inhalation technique score at 4 weeks, 8 weeks and 12 weeks of therapy. <br/ ><br>7. Solicited and unsolicited side effects 4 weeks, 8 weeks and 12 weeks of therapy. <br/ ><br>8. Exacerbations requiring home or hospital treatment at 4 weeks, 8 weeks and 12 weeks of therapy. <br/ ><br>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. <br/ ><br>10. Cost of therapy.Timepoint: 4 weeks, 8 weeks and 12 weeks