Comparison of efficacy and safety of monthly intravenous methylprednisolone pulse therapy, versus daily oral Prednisolone in children with Allergic BronchoPulmonary Aspergillosis
- Conditions
- Health Condition 1: J455- Severe persistent asthma
- Registration Number
- CTRI/2023/03/050237
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Group A (Intervention): Intravenous methylprednisolone 10 mg/kg/day for 3 consecutive days each month, for a total of 4 months will be administered after admission in the Pediatric Pulmonology Unit of the Advanced Pediatrics Centre, PGIMER Chandigarh. In addition, oral itraconazole 5 mg/kg/day will be administered for a total of 16 weeks.
Group B (Comparison): Oral prednisolone 0.5 mg/kg/day for 2 weeks, followed by 0.5mg/kg on alternate days for 8 weeks, followed by slow tapering (5 mg two weekly) over 8 weeks. In addition, oral itraconazole 5 mg/kg/day will be administered for a total of 16 weeks.
1-Children who received systemic corticoids( any preparation, any dose, any route) for more thane weeks in the preceding 6 month.
2- Immunosuppressed states including diabetes mellitus, chronic renal failure, chronic liver failure and others.
3- Underlying disease(e.g. lupus erythematous, IgA nephropathy, amyloidosis
4- Evidence of steroid toxicity; Cataract , glaucoma, body mass index more than 30 or height less than or equal to -3SD
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a)Relapse rate (patients per person year) until the end of 1 year from enrolment <br/ ><br>b)Duration of remission <br/ ><br>c)Compliance to therapy <br/ ><br>Timepoint: At one year of treatment <br/ ><br>
- Secondary Outcome Measures
Name Time Method