Effect of oral prednisolone on symptom duration in non-asthmatic adults with acute lower respiratory tract infection: a randomized clinical trial

Abstract

Importance: Acute lower respiratory tract infection is common and often treated inappropriately in primary care with antibiotics. Corticosteroids are increasingly used but without sufficient evidence.

Objective: To assess the effects of oral corticosteroids for acute lower respiratory tract infection in non asthmatic adults.

Design, setting and participants: Multicenter, placebo controlled, randomized trial (July 2013 to final follow-up October 2014) in 54 family practices in England. 401 adults with acute cough and at least one lower respiratory tract symptom, not requiring immediate antibiotic treatment and no history of chronic
pulmonary disease or use of asthma medication in past 5 years. Two immediately withdrew, one duplicate patient was identified.

Intervention: Two 20mg prednisone tablets (n=198) or matched placebo (n=200) once daily for 5 days.

Main outcomes and measures: Primary - duration of moderately bad or worse cough (0 to 28 days; minimal clinically important difference 3.79 days) and mean symptoms’ severity on days 2 to 4 (scored from 0 (not affected) to 6 (as bad as it could be); minimal clinically important difference 1.66 units). Secondary - duration and severity of acute lower respiratory tract infection symptoms; duration of 43 abnormal peak flow; antibiotic consumption; adverse events.

Results: Among 398 patients with baseline data (mean age 47 (SD 16.0); 63% female; 17% smokers; 77% phlegm; 70% shortness of breath; 47% wheezing; 46% chest pain; 42% abnormal peak flow): 334 (84%) provided cough duration and 369 (93%) symptoms’ severity. Median cough duration was 5 days (IQR, 3-8)
in the prednisolone group and 5 days (IQR, 3-10) in the placebo group, adjusted HR 1.11 (95% CI 0.89 to 1.39, P=0.36, alpha 0.05). Mean symptoms’ severities were 1.99 and 2.16, adjusted difference -0.20 (95% CI -0.40 to 0.00, P=0.05, alpha 0.001). No significant treatment effects were observed for duration or severity of acute lower respiratory tract infection symptoms, duration of abnormal peak flow, antibiotic consumption or non-serious adverse events. There were no serious adverse events.

Conclusions and relevance: Oral corticosteroids should not be used for acute lower respiratory tract infection symptoms in adults without asthma as they do not reduce symptom duration or severity.

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Identifiers

ORCID for Paul Little: orcid.org/0000-0003-3664-1873

ORCID for Michael Moore: orcid.org/0000-0002-5127-4509

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