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Randomized Controlled Trial
. 2024 Aug;166(2):262-270.
doi: 10.1016/j.chest.2024.02.048. Epub 2024 Feb 29.

Effect of Azithromycin on Asthma Remission in Adults With Persistent Uncontrolled Asthma: A Secondary Analysis of a Randomized, Double-Anonymized, Placebo-Controlled Trial

Dennis Thomas  1 , Vanessa M McDonald  2 , Sean Stevens  3 , Melissa Baraket  4 , Sandra Hodge  5 , Alan James  6 , Christine Jenkins  7 , Guy B Marks  8 , Matthew Peters  9 , Paul N Reynolds  10 , John W Upham  11 , Ian A Yang  12 , Peter G Gibson  2
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Free article
Randomized Controlled Trial

Effect of Azithromycin on Asthma Remission in Adults With Persistent Uncontrolled Asthma: A Secondary Analysis of a Randomized, Double-Anonymized, Placebo-Controlled Trial

Dennis Thomas et al. Chest. 2024 Aug.
Free article

Abstract

Background: Asthma remission is a potential treatment goal.

Research question: Does adding azithromycin to standard therapy in patients with persistent uncontrolled asthma induce remission compared with placebo?

Study design and methods: This secondary analysis used data from the Asthma and Macrolides: the Azithromycin Efficacy and Safety (AMAZES) clinical trial-a double-anonymized placebo-controlled trial that evaluated the safety and efficacy of azithromycin on asthma exacerbations. The primary remission definition (referred to as clinical remission) was zero exacerbations and zero oral corticosteroids during the previous 6 months evaluated at 12 months and a 5-item Asthma Control Questionnaire score ≤ 1 at 12 months. Secondary remission definitions included clinical remission plus lung function criteria (postbronchodilator FEV1 ≥ 80% or postbronchodilator FEV1 ≤ 5% decline from baseline) and complete remission (sputum eosinophil count < 3% plus the aforementioned criteria). Sensitivity analyses explored the robustness of primary and secondary remission definitions. The predictors of clinical remission were identified.

Results: A total of 335 participants (41.5% male; median age, 61.01 years; quartile 1-3, 51.03-68.73) who completed the 12-month treatment period were included in the analysis. Twelve months of treatment with azithromycin induced asthma remission in a subgroup of patients, and a significantly higher proportion in the azithromycin arm achieved both clinical remission (50.6% vs 38.9%; P = .032) and clinical remission plus lung function criteria (50.8% vs 37.1%; P = .029) compared with placebo, respectively. In addition, a higher proportion of the azithromycin group achieved complete remission (23% vs 13.7%; P = .058). Sensitivity analyses supported these findings. Baseline factors (eg, better asthma-related quality of life, absence of oral corticosteroid burst in the previous year) predicted the odds of achieving clinical remission. Azithromycin induced remission in both eosinophilic and noneosinophilic asthma.

Interpretation: In this study, adults with persistent symptomatic asthma achieved a higher remission rate when treated with azithromycin. Remission on treatment may be an achievable treatment target in moderate/severe asthma, and future studies should consider remission as an outcome measure.

Keywords: asthma; azithromycin; remission.

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Conflict of interest statement

Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: D. T. reports grants from GlaxoSmithKline, outside the submitted work. V. M. M. reports grants and personal fees from GlaxoSmithKline, AstraZeneca and Boehringer Ingelheim, outside the submitted work. C. J. reports personal fees for advisory board work, conducting meetings and developing educational content, and nonfinancial support from AstraZeneca, personal fees for advisory board work from Boehringer Ingleheim, grants and personal fees for advisory board work from GlaxoSmithKline, and personal fees for advisory board work, facilitating symposia and developing educational content from Novartis, outside the submitted work. M. P. reports personal fees for advisory board work from Sanofi Genzyme, Novartis Pharmaceuticals and AstraZeneca, outside the submitted work. J. W. U. has received speaker fees, conference travel support and consultancy fees from AstraZeneca, GlaxoSmithKline, Novartis, and Sanofi, outside the submitted work. P. G. G. reports personal fees for lectures from AstraZeneca, GlaxoSmithKline, and Novartis, and grants from AstraZeneca and GlaxoSmithKline, outside the submitted work. None declared (S. S., M. B., S. H., A. J., G. B. M., P. N. R , I. A. Y.).

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