CTRI/2024/07/070571Not yet recruitingNot Applicable
Nebulised Budesonide as an adjunct to standard first line therapy for emergency management of moderate to severe acute asthma exacerbations in children aged 2 to 18 years age.
Government Medical College and Hospital Chandigarh1 site in 1 country100 target enrollmentStarted: July 23, 2024Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Difference in proportion of patients who needed systemic corticosteroid at one hour of presentation in each group
Study Overview
Brief Summary
This study is a randomized, double blind, parallel group trial comparing the efficacy of addition of budesonide to nebulized salbutamol against standard therapy of only nebulized salbutamol for management of moderate to severe acute asthma exacerbations in children aged 2 to 18 years presenting to the Paediatric emergency department. The primary outcome will be to measure the requirement for systemic corticosteroids at hour of admission .The secondary outcome will be to compare the effect of the intervention on improvement in Paediatric asthma severity score and duration of hospital stay.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 2.00 Year(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children 2 to 18 years of age diagnosed to have an acute exacerbation of asthma.
- •The diagnosis will be based on the following criteria: 1.Children aged 2 to 18 years of age presenting to paediatric emergency with acute exacerbation of asthma having Paediatric asthma severity score of 8 to 15 And
- •Is a known case of childhood asthma or past history of at least two similar episodes in last 12 months relieved with bronchodilator therapy or already on controller therapy or with family history of asthma ,atopy ,nebulisations or personal history of atopic dermatitis, food allergy or allergic rhinitis.
Exclusion Criteria
- •Presence of signs or symptoms suggestive of pneumonia, tuberculosis, heart disease croup, pertussis, measles, foreign body aspiration.
- •2.Documented fever >38 degrees Celsius 3.Life threatening exacerbation attack necessitating PICU admission and/or intubation owing to respiratory failure or depressed consciousness (GCS<8), and/or inotropes 4.Children enrolled in any other trial.
- •5.Children previously enrolled in this trial within last one month 6.Children who have received systemic corticosteroids for any indication within the previous 4weeks.
Outcomes
Primary Outcomes
Difference in proportion of patients who needed systemic corticosteroid at one hour of presentation in each group
Time Frame: One hour of presentation
Secondary Outcomes
- Difference in mean reduction in Pediatric asthma severity score indicating clinical improvement at one hour of presentation
- Difference in mean duration of hospital stay in each group
Investigators
Dr Jigyasa Goswami
Government Medical College and Hospital, Chandigarh
Study Sites (1)
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