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This blinded trial with concealed randomisation compared doubling the dose of inhaled corticosteroid for 14 days with continuing the same dose when asthma symptoms or peak flow worsened in patients monitoring themselves daily at home. The 390 patients enrolled had been given oral corticosteroid or transiently doubled their inhaled corticosteroid dose in the past year for worsening asthma, but had been stable for at least 2 weeks before entry to the study. All patients were using an inhaled corticosteroid, with most using a low or moderate dose. They were randomised to receive a study inhaler, identical in appearance to their usual steroid inhaler, which contained either further steroid or placebo. During the 1 year study period 53% of patients started their study inhaler due to worsening asthma, and 11% in the treatment group versus 12% in the placebo group started oral prednisolone because of a fall in peak flow of >40%, subjectively worsening asthma, or on advice of their general practitioner (p = 0.8). There was still no difference in oral steroid use when analysed among those who used the study inhaler (per protocol analysis) or among those in the subgroups on low/moderate versus high dose inhaled corticosteroid at baseline.
While this study does not lend support for the practice of patients doubling their inhaled corticosteroid for worsening asthma as part of their self-management plan, it also does not definitively refute it. Despite being a large trial, it was significantly underpowered to detect what could be a clinically important reduction in systemic steroid use because of the low event rate.
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