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Can oral corticosteroids reduce the severity or duration of an acute cough, and the associated National Health Service and societal costs, in adults presenting to primary care?: study protocol for a randomised controlled trial

Downing, Harriet E.; Carroll, Fran; Brookes, Sara T.; Hollinghurst, Sandra; Timmins, David; Orton, Elizabeth; Wang, Kay; Kendrick, Denise; Little, Paul; Moore, Mike V.; Harnden, Anthony; Thompson, Matthew; May, Margaret T.; Hay, Alastair D.

Authors

Harriet E. Downing

Fran Carroll

Sara T. Brookes

Sandra Hollinghurst

David Timmins

Kay Wang

DENISE KENDRICK denise.kendrick@nottingham.ac.uk
Professor of Primary Care Research

Paul Little

Mike V. Moore

Anthony Harnden

Matthew Thompson

Margaret T. May

Alastair D. Hay



Abstract

Background:
Acute lower respiratory tract infection (LRTI) is one of the most common conditions managed internationally and is costly to health services and patients. Despite good evidence that antibiotics are not effective for improving the symptoms of uncomplicated LRTI, they are widely prescribed, contributing to antimicrobial resistance. Many of the symptoms observed in LRTI are mediated by inflammatory processes also observed in exacerbations of asthma, for which there is strong evidence of corticosteroid effectiveness. The primary aim of the OSAC (Oral Steroids for Acute Cough) Trial is to determine whether oral prednisolone (40 mg daily for 5 days) can reduce the duration of moderately bad (or worse) cough and the severity of all its associated symptoms on days 2 to 4 post-randomisation (day 1 is trial entry) by at least 20% in adults ≥18 years with acute LRTI presenting to primary care.

Methods/design:
OSAC is a two-arm, multi-centre, placebo-controlled, randomised superiority trial. The target sample size is 436 patients, which allows for a 20% dropout rate. Patients will be recruited from primary care sites (General Practitioner surgeries) across England and followed up until symptom resolution. The two primary clinical outcomes are the duration of moderately bad (or worse) cough, and the severity of all its associated symptoms on days 2 to 4 post-randomisation. Secondary outcomes include: antibiotic consumption; symptom burden; adverse events; participant satisfaction with treatment and intention to consult for future similar illnesses. A parallel economic evaluation will investigate the cost-effectiveness of the intervention.

Discussion:
Results from the OSAC trial will increase knowledge regarding the clinical and cost-effectiveness of corticosteroids for LRTI, and will establish the potential of a new treatment option that could substantially improve patient health. We have chosen a relatively high ‘efficacy dose’ as this will enable us to decide on the potential for further research into lower dose oral and/or inhaled corticosteroids. This trial will also contribute to a growing body of research investigating the natural course of this very common illness, as well as the effects of steroids on the undesirable inflammatory symptoms associated with infection.

Trial registration:
Current Controlled Trials ISRCTN57309858 (31 January 2013).

Journal Article Type Article
Publication Date Mar 7, 2015
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 16
Issue 1
Article Number 78
APA6 Citation Downing, H. E., Carroll, F., Brookes, S. T., Hollinghurst, S., Timmins, D., Orton, E., …Hay, A. D. (2015). Can oral corticosteroids reduce the severity or duration of an acute cough, and the associated National Health Service and societal costs, in adults presenting to primary care?: study protocol for a randomised controlled trial. Trials, 16(1), https://doi.org/10.1186/s13063-015-0569-5
DOI https://doi.org/10.1186/s13063-015-0569-5
Keywords Oral Corticosteroids; Acute Cough; National Health Service; Adults; Cost-effectiveness; Study Protocol; Randomised Controlled Trial
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0569-5
Related Public URLs https://creativecommons.org/licenses/by/4.0/
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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