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A clinical trial to study the effect of addition of Budesonide nebulisation to standard first line therapy in management of acute asthma exacerbations.

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070571
Enrollment
100
Registered
2024-07-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J459- Other and unspecified asthma

Interventions

Intervention1: Budesonide: Patients will receive oxygen driven (6L/min) nebulisation via face mask containing Budesonide 0.5 mg (2 ml) plus Salbutamol 2.5 mg (0.5ml) plus Normal saline 1ml (as diluent

Sponsors

Government Medical College and Hospital Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

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 2. 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

Exclusion criteria: 1. 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 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

Design outcomes

Primary

MeasureTime frame
Difference in proportion of patients who needed systemic corticosteroid at one hour of presentation in each group Timepoint: One hour of presentation

Secondary

MeasureTime frame
Difference in mean duration of hospital stay in each group Timepoint: At discharge;Difference in mean reduction in Pediatric asthma severity score indicating clinical improvement at one hour of presentation Timepoint: One hour of presentation

Countries

India

Contacts

Public ContactDr Jigyasa Goswami

Government Medical College and Hospital, Chandigarh

drpankaj.kr@gmail.com8894286467

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026