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

Not yet recruiting

Brief Summary: 1. Children aged 6-12 years presenting to the Department of Pediatrics (OPD or Allergy & Asthma Clinic) at PGIMER with symptoms of recurrent, episodic, reversible wheeze, and/or shortness of breath, and/or chest tightness and/or cough will be screened for eligibility criteria.

Parents of those fulfilling the Inclusion and Exclusion criteria will be clearly explained about the purpose and nature of this study, associated benefits and risks, and management protocol. This will be done verbally as well as with a written Participant Information Sheet. Parents and children will be provided the opportunity to ask questions, which will be answered by the Investigator. They will then be invited to permit their child to participate in the study.

2. Parents expressing willingness for their child to participate in the study will be offered an Informed Consent Form. Parents and children will be provided the opportunity to ask questions, which will be answered by the Investigator. Children will be enrolled only after obtaining written informed consent from parents. If neither parent is available, a Legally Acceptable Representative will be considered if he/she is also the primary caregiver for the child. In addition, children older than 8 years will be offered an Assent form, and enrolled in this age group will be only with written assent of the child.

Recruitment & Eligibility

Inclusion Criteria

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

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.

Primary Outcome Measures

Name	Time	Method
Increase in PEFR (%) 4 weeks after initiation of therapy (compared to baseline)	Increase in PEFR (%) 4 weeks after initiation of therapy (compared to baseline)

Secondary Outcome Measures

Name	Time	Method
1) Increase in PEFR (%) 8 weeks after initiation of therapy	2) Increase in PEFR (%) 12 weeks after initiation of therapy

Locations (1): Allergy and Asthma Clinic, Department of Paediatrics
🇮🇳
Chandigarh, CHANDIGARH, India
Allergy and Asthma Clinic, Department of Paediatrics
🇮🇳Chandigarh, CHANDIGARH, India
Himanshu Gupta
Principal investigator
9799833433
himanshu.gupta678@gmail.com