Nowak 2010.
Methods | Randomised, placebo‐controlled, dose‐escalation, multicentre trial | |
Participants | 29 patients with severe acute asthma in emergency department setting | |
Interventions | All patients received nebulised albuterol and ipratropium with oral corticosteroids. Patients with FEV1< 55% were randomised to MN‐221 (bedoradrine) or placebo | |
Outcomes | 13 patients received placebo and 16 patients received MN‐221. MN‐221 was administered at the following doses: 5 at 240 ug over 15 min, 6 at 450 ug over 15 min, and 5 at 1080 ug over two hours (2 received 1995 ug). Reduced hospitalisation rate: MN‐221 4/16 (25%) vs placebo 7/13 (54%). Improved FEV1: change in baseline AUC1‐5hr was 43% higher in the MN‐221 arm compared to placebo. No significant difference in adverse events between arms: ECG, heart rate, etc |
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Notes | Abstract format only. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear. Conference abstract – limited information |
Allocation concealment (selection bias) | Unclear risk | Unclear. Conference abstract – limited information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unclear. Conference abstract – limited information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear. Conference abstract – limited information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear. Conference abstract – limited information |
Selective reporting (reporting bias) | Unclear risk | Unclear. Conference abstract – limited information |
CASS: Clinical Asthma Severity Score FEV1: forced expiratory volume in 1 sec iv: intravenous NPV: negative predictive value PFTs: pulmonary function tests