Background The majority of UK adults experience at least one lower respiratory tract infection (LRTI, or acute bronchitis) a year. Despite an absence of evidence in this patient group, some GPs prescribe inhaled or oral corticosteroids. OSAC sought to demonstrate ‘proof of concept’ symptomatic effectiveness of a moderate dose of oral corticosteroid for adults without asthma or COPD with acute LRTI.
Methods OSAC was a double blind, placebo controlled RCT set in GP practices in England, powered to investigate if oral prednisolone reduces the duration of moderately bad or worse cough and/or the severity of its associated symptoms, when compared to placebo, by at least 20%. Adults (≥18 years) with acute (≤28 days) cough, for whom same-day antibiotics were not clinically indicated, and without asthma or COPD, received 40 mg oral prednisolone or matched placebo for 5 days. Symptom diaries, completed for up to 28 days, measured two primary outcomes: the duration of moderately bad or worse cough; and the average severity of all symptoms on days 2 to 4 on a scale of 0–6. We sought to demonstrate a minimum clinically important reduction of 20% in each outcome.
Results 398 participants were randomised to either prednisolone or placebo tablets (198 and 200 respectively) from 54 UK primary care sites. Attrition was lower than expected, giving over 85% power for the two primary outcomes. Data were analysed on an intention-to-treat basis. The median duration of moderately bad or worse cough was 5 days in both groups (IQRs 2–8 and 3–8 for prednisolone and placebo respectively). Adjusting for trial centre and baseline characteristics, this gave a hazard ratio of 1.11 (95% CI 0.89 to 1.39, p = 0.35). Symptom severity was lower in the prednisolone group (mean 1.99 vs 2.16), adjusted difference -0.090 (-0.212 to 0.003, p = 0.152).
Conclusions We found no evidence that a moderately high dose of oral corticosteroid reduced either duration of moderately bad (or worse) cough, or symptom severity at days 2 to 4 in adults without asthma or COPD with LRTI not requiring immediate antibiotic treatment. Lower dose oral or high dose inhaled corticosteroids are also unlikely to be beneficial.