None listed
Conditions
Brief summary
In this study, we will compared the clinical and immunological efficacy of nebulized corticosteroid (CS) to systemic route during treatment of moderate asthma attack in children. Treatment responses will assessed by monitoring clinical and immunological parameters including; scores of pulmonary index (PIS) and total symptom/medication, peak expiratory flow (PEF) rate as well as cytokine responses and percentages of Treg cells.
Interventions
1) The fluticasone group: Receiving active nebulized fluticasone (0.5 mg/2ml; four times a day for one week) and placebo tablets (for seven days).
2) The methylprednisolone group: Receiving active methylprednisolone tablets orally (1 mg/kg/day for 4 days followed by 0.5 mg/kg/day for three more days) in addition to placebo nebules (2 ml; four times a day for one week).
The overall duration of the intervention will be 1 week.
The monitor adherence to the intervention will control by drug tablet
1) The fluticasone group: Receiving active nebulized fluticasone (0.5 mg/2ml; four times a day for one week) and placebo tablets (for seven days). 2) The methylprednisolone group: Receiving active methylprednisolone tablets orally (1 mg/kg/day for 4 days followed by 0.5 mg/kg/day for three more days) in addition to placebo nebules (2 ml; four times a day for one week). The overall duration of the intervention will be 1 week. The monitor adherence to the intervention will control by drug tablet return and regular admission to the hospital for the clinical and laboratory evaluation.
Sponsors
Safa Baris
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
1 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Asthma attack patients who have pulmonary index score between 6 and 12 and/or peak expiratory flow of 60-80% predicted after three doses of nebulized salbutamol at Emergency Room (ER).
Exclusion criteria
children with concomitant cardiopulmonary disease, systemic CS use during the last 2 weeks prior to the exacerbation, admission to hospital (including patients requiring intense effort to breath, altered state of consciousness, bradycardia, room air oxygen saturation of less than 88%)
Outcome results
None listed