Efficacy and safety of oral corticosteroids to treat outpatients with acute exacerbations of COPD in primary care: a multicentre pragmatic randomised controlled study

Jean-Laurent Thebault, Nicolas Roche, Hendy Abdoul, Alain Lorenzo, Thomas Similowski, Christian Ghasarossian, Jean-Laurent Thebault, Nicolas Roche, Hendy Abdoul, Alain Lorenzo, Thomas Similowski, Christian Ghasarossian

Abstract

Aim: To compare prednisone and placebo for the treatment of outpatients treated for acute exacerbations of chronic obstructive pulmonary disease (COPD) in a primary care setting.

Methods: A multicentre, parallel, double-blind, pragmatic randomised controlled trial was performed in France. A total of 66 general practitioners included patients aged ≥40 years with cumulative smoking of ≥10 pack-years and a diagnosis of certain or likely acute exacerbation of COPD. Oral prednisone (40 mg) or placebo were administered daily for 5 days. The main outcome was treatment failure at 8 weeks, defined as a composite criterion based on the occurrence of at least one of the following: unplanned visit to an emergency department or to a practitioner in the ambulatory setting, hospital admission or death. The planned sample size was 202 patients per group.

Results: 175 patients were included from February 2015 to May 2017 (43% of the planned sample). All-cause 8-week treatment failure rate was 42.0% in the prednisone group and 34.5% in the placebo group (relative risk 1.22, 95% CI 0.87-1.69, p=0.25). Respiratory-related 8-week treatment failure rate was 27.6% in the prednisone group and 13.6% in the placebo group (relative risk 2.00, 95% CI 1.15-3.57, p=0.015).

Conclusion: Although the planned sample size was not achieved, the study does not suggest that oral corticosteroids are more effective than placebo for the treatment of an acute exacerbation of COPD in a primary care setting.

Conflict of interest statement

Conflict of interest: J-L. Thebault has nothing to disclose. Conflict of interest: N. Roche reports research funds and fees from Boehringer Ingelheim, Novartis, Pfizer and GSK, and fees for advisory boards, consultation, education and presentations from MSD, AstraZeneca, Chiesi, Sanofi and Zambon. Conflict of interest: H. Abdoul has nothing to disclose. Conflict of interest: A. Lorenzo reports support for attending a meeting from Novartis France. Conflict of interest: T. Similowski reports research funds and fees from Lungpacer Inc. and fees for consultation and meetings from ADEP assistance, AstraZeneca France, Chiesi France, KPL Consulting, Lungpacer Inc., Novartis France, TEVA France and Vitalaire. Conflict of interest: C. Ghasarossian has nothing to disclose.

Copyright ©The authors 2023.

Figures

FIGURE 1
FIGURE 1
Flow chart.
FIGURE 2
FIGURE 2
Quality-adjusted time without symptoms and toxicity. Rel: time with exacerbation; Tox: time with toxicity; TWiST: time without symptoms or toxicity.

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