IngentaConnect Comparison of Nebulised Budesonide and Prednisolone in Severe Ast...

Abstract:

Background: Short courses of oral prednisolone are used as rescue therapy for severe asthma exacerbations. This study compares nebulised budesonide or oral prednisolone, both followed by budesonide Turbohaler®, as a treatment for severe asthma exacerbations, in the absence of life-threatening features.

Patients and Methods: Thirteen adults admitted to hospital were randomised to receive either nebulised budesonide (4mg 8-hourly) for 48 to 72 hours followed by budesonide Turbohaler (1600µg twice daily for 7 days, then 800µg twice daily for 21 days) for 28 days or prednisolone (40mg daily) for 9 to 11 days followed by budesonide Turbohaler (800µg twice daily) for 21 days. The primary efficacy variable was the change from baseline at 48 hours in forced expiratory volume in 1 second (FEV). Secondary efficacy variables included an assessment of symptom severity (0 = none, 1 = mild, 2 = moderate, 3 = severe).

Results: Difficulties were experienced with patient recruitment in the emergency setting. The results presented are from an incomplete study. Change in FEV from baseline to 48 hours was not statistically significantly different between the groups (the study was underpowered to detect a difference in change in FEV, as the power to detect a prespecified difference between groups was 18%). Nebulised budesonide significantly reduced the severity of wheeze after 24 hours compared with prednisolone [estimate of treatment effect = -0.95; 95% confidence intervals (CI) = -1.76 to -0.15; p = 0.0336 between groups] and 48 hours (estimate of treatment effect = -0.79; 95% CI = -1.42 to -0.15; p = 0.0326 between groups).

Conclusion: While oral prednisolone or intravenous hydrocortisone, oxygen and bronchodilators are the mainstay of acute management in severe asthma, the results of this study suggest that nebulised budesonide may assist in regaining control of symptoms during exacerbations of asthma.

Keywords: Acute asthma, treatment; Antiasthmatics, therapeutic use; Budesonide, therapeutic use; Prednisolone, therapeutic use

Document Type: Original article

Affiliations: 1: Royal Hallamshire Hospital, Sheffield, South Yorkshire, England 2: City Hospital, Nottingham, Nottinghamshire, England 3: Arrowe Park Hospital, Upton, Wirral, Merseyside, England 4: Darlington Memorial Hospital, Darlington, Durham, England 5: Morriston Hospital, Swansea, West Glamorgan, Wales 6: AstraZeneca, Kings Langley, Hertfordshire, England

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Comparison of Nebulised Budesonide and Prednisolone in Severe Asthma Exacerbation in Adults