Health Condition 1: J455- Severe persistent asthma
Conditions
Interventions
Intervention1: Intravenous methylprednisolone: 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 Pediat
Sponsors
Post Graduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a)Relapse rate (patients per person year) until the end of 1 year from enrolment b)Duration of remission c)Compliance to therapy Timepoint: At one year of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Treatment failure defined as any of the following: â?¢ Persistence of clinical symptoms and/or signs despite appropriate compliance to therapy â?¢ Cessation of therapy for any reason â?¢ Occurrence of acute exacerbation of ABPA b) Change in serum IgE from baseline to end of follow-up. c) Change in serum IgE between follow-up visits. d) Change in FEV1 (in those who can perform spirometry) from baseline to end of therapy. e) Change in FEV1 (in those who can perform spirometry) between follow-up visits. f) Time to first exacerbation after stopping treatment g) Cumulative dose of oral glucocorticoids received h) Cost of therapy in both groups i) Time to first relapse j) Proportion of subjects with a composite response (as defined below) at 8 weeks of treatment k) Therapy associated adverse events including, impaired glucose metabolism, obesity, cushingoid habitus, cataract, glaucoma, hirsutism, growth abnormality Timepoint: Enrolment of patients will be during the first 18 months after IEC approval and CTRI registration, follow up will continue till 30 months after initiating the study, and data analysis will take place in the last 6 months | — |
Countries
India
Contacts
Public ContactDr Sachin singh
Post Graduate Institute of Medical Education and Research
Outcome results
None listed