In children less than 5 years of age with wheezing, inhaled drugs are given for treatment. This study aims to find out which treatment is better; whether inhaled drugs given daily or only during problematic days.
- Conditions
- Health Condition 1: J455- Severe persistent asthma
- Registration Number
- CTRI/2023/07/055096
- Lead Sponsor
- All India Institute of Medical Science AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Children aged < 5 years who have
1)= Three episodes of Wheezing/year
2)Symptoms (Cough, wheeze, difficulty in breathing) for >7-10 days during upper respiratory tract infections
3)Between the episodes have cough, wheeze, or heavy breathing (occasional or during play/laughing)
4)Allergic sensitization or atopic dermatitis or food allergy or family history of asthma.
(According to GINA guidelines 2022)
1)Children requiring Pediatric Intensive Care Unit admission due to wheezing
2)Children with = 2 In-Patient admission or > 3 times Oral corticosteroid administration for wheezing in the past 1 year
3)Children with other co-morbidities such as Gastro-esophageal reflux disease
4)Children with other chronic lung diseases- Cystic fibrosis, Primary ciliary dyskinesia, prematurity,etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Test for Respiratory and Asthma Control in Kids (TRACK) score in children on Intermittent inhaled budesonide therapy in comparison to daily inhaled budesonide therapy.Timepoint: Baseline, <br/ ><br>First month, <br/ ><br>Second month, <br/ ><br>Third month.
- Secondary Outcome Measures
Name Time Method 1.To compare the frequency of wheezing exacerbation requiring oral glucocorticoids/emergency visit/Hospitalizations <br/ ><br>2.Proportion of episode-free days in both the groups <br/ ><br>3.Cumulative dose of ICS used between both the groups <br/ ><br>4.Frequency of adverse effects between both the groups <br/ ><br>Timepoint: baseline 1st month second month third month