Dataset Information

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

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.

SUBMITTER: Thebault JL

PROVIDER: S-EPMC10493709 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

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

Thebault Jean-Laurent JL Roche Nicolas N Abdoul Hendy H Lorenzo Alain A Similowski Thomas T Ghasarossian Christian C

ERJ open research 20230911 5

<h4>Aim</h4>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.<h4>Methods</h4>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 m ...[more]

PMID: 37701369

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Project description:ImportanceChronic obstructive pulmonary disease (COPD) is a major global health issue and theophylline is used extensively. Preclinical investigations have demonstrated that low plasma concentrations (1-5 mg/L) of theophylline enhance antiinflammatory effects of corticosteroids in COPD.ObjectiveTo investigate the effectiveness of adding low-dose theophylline to inhaled corticosteroids in COPD.Design, setting, and participantsThe TWICS (theophylline with inhaled corticosteroids) trial was a pragmatic, double-blind, placebo-controlled, randomized clinical trial that enrolled patients with COPD between February 6, 2014, and August 31, 2016. Final follow-up ended on August 31, 2017. Participants had a ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC) of less than 0.7 with at least 2 exacerbations (treated with antibiotics, oral corticosteroids, or both) in the previous year and were using an inhaled corticosteroid. This study included 1578 participants in 121 UK primary and secondary care sites.InterventionsParticipants were randomized to receive low-dose theophylline (200 mg once or twice per day) to provide plasma concentrations of 1 to 5 mg/L (determined by ideal body weight and smoking status) (n = 791) or placebo (n = 787).Main outcomes and measuresThe number of participant-reported moderate or severe exacerbations treated with antibiotics, oral corticosteroids, or both over the 1-year treatment period.ResultsOf the 1567 participants analyzed, mean (SD) age was 68.4 (8.4) years and 54% (843) were men. Data for evaluation of the primary outcome were available for 1536 participants (98%) (772 in the theophylline group; 764 in the placebo group). In total, there were 3430 exacerbations: 1727 in the theophylline group (mean, 2.24 [95% CI, 2.10-2.38] exacerbations per year) vs 1703 in the placebo group (mean, 2.23 [95% CI, 2.09-2.37] exacerbations per year); unadjusted mean difference, 0.01 (95% CI, -0.19 to 0.21) and adjusted incidence rate ratio, 0.99 (95% CI, 0.91-1.08). Serious adverse events in the theophylline and placebo groups included cardiac, 2.4% vs 3.4%; gastrointestinal, 2.7% vs 1.3%; and adverse reactions such as nausea (10.9% vs 7.9%) and headaches (9.0% vs 7.9%).Conclusions and relevanceAmong adults with COPD at high risk of exacerbation treated with inhaled corticosteroids, the addition of low-dose theophylline, compared with placebo, did not reduce the number COPD exacerbations over a 1-year period. The findings do not support the use of low-dose theophylline as adjunctive therapy to inhaled corticosteroids for the prevention of COPD exacerbations.Trial registrationisrctn.org Identifier: ISRCTN27066620.

Dataset Information

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

Aim

Methods

Results

Conclusion

Publications

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

Similar Datasets

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