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

Effect of oral prednisolone on symptom duration in non-asthmatic adults with acute lower respiratory tract infection: a randomized clinical trial
Effect of oral prednisolone on symptom duration in non-asthmatic adults with acute lower respiratory tract infection: a randomized clinical trial
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.
1538-3598
721-730
Hay, Alastair D.
bfae9e44-ae9b-473c-923f-1dea50747023
Little, Paul
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Harnden, Anthony
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Thompson, Matthew
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Wang, Kay
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Kendrick, Denise
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Orton, Elizabeth
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Brookes, Sara T.
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Young, Grace J
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May, Margaret
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Hollinghurst, Sandra
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Carroll, Fran E
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Downing, Harriet
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Timmins, David
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Lafond, Natasher
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El-Gohary, Magdy
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Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Hay, Alastair D.
bfae9e44-ae9b-473c-923f-1dea50747023
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Harnden, Anthony
bbb10d37-b475-4c3c-b669-427d4d7ead8c
Thompson, Matthew
fc8976af-93f7-4da9-8acf-68e1f562de3d
Wang, Kay
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Kendrick, Denise
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Orton, Elizabeth
305959ef-1a08-4336-9b6f-3f13c769e634
Brookes, Sara T.
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Young, Grace J
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May, Margaret
4cf5ac78-4cd7-4eef-9244-a780ac3105db
Hollinghurst, Sandra
e0ec6e20-afca-437a-a2e1-4250ea157811
Carroll, Fran E
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Downing, Harriet
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Timmins, David
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Lafond, Natasher
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El-Gohary, Magdy
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Moore, Michael
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Hay, Alastair D., Little, Paul, Harnden, Anthony, Thompson, Matthew, Wang, Kay, Kendrick, Denise, Orton, Elizabeth, Brookes, Sara T., Young, Grace J, May, Margaret, Hollinghurst, Sandra, Carroll, Fran E, Downing, Harriet, Timmins, David, Lafond, Natasher, El-Gohary, Magdy and Moore, Michael (2017) Effect of oral prednisolone on symptom duration in non-asthmatic adults with acute lower respiratory tract infection: a randomized clinical trial. JAMA, 318 (8), 721-730. (doi:10.1001/jama.2017.10572).

Record type: Article

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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Accepted/In Press date: 21 July 2017
e-pub ahead of print date: 22 August 2017
Published date: 22 August 2017

Identifiers

Local EPrints ID: 413422
URI: http://eprints.soton.ac.uk/id/eprint/413422
ISSN: 1538-3598
PURE UUID: ce729c90-95b5-4e4a-9e4f-3dd42f508e30
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509

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Date deposited: 24 Aug 2017 16:30
Last modified: 12 Jul 2024 04:05

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Contributors

Author: Alastair D. Hay
Author: Paul Little ORCID iD
Author: Anthony Harnden
Author: Matthew Thompson
Author: Kay Wang
Author: Denise Kendrick
Author: Elizabeth Orton
Author: Sara T. Brookes
Author: Grace J Young
Author: Margaret May
Author: Sandra Hollinghurst
Author: Fran E Carroll
Author: Harriet Downing
Author: David Timmins
Author: Natasher Lafond
Author: Magdy El-Gohary
Author: Michael Moore ORCID iD

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