Steroids In The Management Of Acute Asthma Exacerbations In Children, Which Form Is More Suitable?

• Status: Unknown status
• Trial end date: 2018-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to compare the efficacy of a single dose of intramuscular dexamethasone versus 3 days of twice-daily oral prednisolone in the management of mild to moderate asthma exacerbations in children and test whether this single dose of intramuscular dexamethasone 0.6 mg/kg (max. 18 mg) is equal to prednisolone 1 mg/kg/day (max. 40 mg) in the treatment of exacerbations of asthma in children, as measured by the Pediatric Respiratory Assessment Measure (PRAM).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Ages 2 to 16 years

• Background history of asthma

• Presentation with an asthma exacerbation requiring repeated salbutamol after 20 minutes.

Exclusion Criteria:

• Less than 2 years old or over 16 years

• Critical or life-threatening asthma

• Known tuberculosis exposure

• Active varicella or herpes simplex infection

• Documented concurrent infection with Respiratory syncytial virus

• Fever >39.5°C

• Use of oral corticosteroids in the previous four weeks

• Concurrent stridor

• Significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric