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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Harriet E Downing, Fran Carroll, Sara T Brookes, Sandra Hollinghurst, David Timmins, Elizabeth Orton, Kay Wang, Denise Kendrick, Paul Little, Mike V Moore, Anthony Harnden, Matthew Thompson, Margaret T May, Alastair D Hay, on behalf of the OSAC trial team

Published in: Trials | Issue 1/2015

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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).
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Harriet E Downing
Fran Carroll
Sara T Brookes
Sandra Hollinghurst
David Timmins
Elizabeth Orton
Kay Wang
Denise Kendrick
Paul Little
Mike V Moore
Anthony Harnden
Matthew Thompson
Margaret T May
Alastair D Hay
on behalf of the OSAC trial team
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0569-5

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