Study comparing drug combination (low-dose steroid/long acting B2 agonist) versus medium-dose steroid as an inhaled medication in children with asthma

Not Applicable

• Conditions: Health Condition 1: J454- Moderate persistent asthma

• Registration Number: CTRI/2020/06/026247
• Lead Sponsor: PGIMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 <80% of predicted, FEV1/FVC ratio <80%, 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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified