Starobin 2008.
| Methods | Design: randomised controlled trial, 3 arms | |
| Participants | Randomised: nebulised fluticasone 24, IV methylprednisolone 23, combined 26 Age (mean ± SD) (years): nebulised fluticasone 37.9 ± 16.8, IV methylprednisolone 47 ± 14.6, combined 48.2 ± 17.2 Sex (M/F): nebulised fluticasone 11/13, IV methylprednisolone 9/14, combined 15/11 Baseline PEF mean ± SD (% predicted): nebulised fluticasone 42 ± 27.5, IV methylprednisolone 35.2 ± 21.3, combined 38.9 ± 18.0 Inclusion criteria: ED patients aged 18 to 75 years with acute asthma, history of atopic or idiosyncratic asthma with any grade of severity Exclusion criteria: chronic use of systemic corticosteroids for severe asthma; history of severe cardiac, renal or liver disease; tracheostomy; requiring mechanical ventilation |
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| Interventions | Group 1 patients (Flixotide group) received inhalation of Flixotide Nebules® (fluticasone propionate) (Glaxo Wellcome, Australia) 2 mL (0.5 mg) Group 2 patients (the Solumedrol® group) received IV infusion of Solumedrol (methylprednisolone) 125 mg within the first 30 min after admission Group 3 patients (combined group) were treated by both routes of corticosteroids All patient received oxygen at a rate of 5 L/min, salbutamol 0.5 mL plus ipratropium bromide 1 mg plus 2 mL of normal saline 0.9% every 20 min during the first hour of ED treatment Decisions regarding admission to the internal medicine ward, intensive care unit or discharge, as well as additional treatment decisions were made independently by the local ED staff |
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| Outcomes | Primary outcome: hospital admissions. Other outcomes included PEF, oxygen saturation, HR and dyspnoea score, measured before and 2 h after ED treatment was initiated. Corticosteroids were continued for 1 week following the ED visit according to the protocol arm, and hospital admission/discharge rate, ED re‐admissions in the week after enrolment and other major events related to asthma were recorded. (Only the 0‐ and 2‐h outcomes contribute to this review) It is stated there were no serious adverse event, although 1 patient (treatment group not stated) required mechanical ventilation and 1 patient from group 3 (both ICS and systemic corticosteroid) returned to the ED during the first week of the study |
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| Notes | ICS versus systemic corticosteroid subgroup, and ICS versus placebo (systemic corticosteroid in both groups) Trial added in 2012 update |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Reported as "random consecutive case fashion to one of three protocol arms" |
| Allocation concealment (selection bias) | Unclear risk | Unreported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open label |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Open label |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear |
| Selective reporting (reporting bias) | Unclear risk | No apparent indication of reporting bias |