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Azithromycin for sarcoidosis cough: an open-label exploratory clinical trial.

ABSTRACT: Background:Chronic cough is a distressing symptom for many people with pulmonary sarcoidosis. Continuous treatment with a macrolide antibiotic may improve cough. We aimed to assess the potential efficacy of azithromycin in patients with sarcoidosis and self-reported cough.

Methods:We conducted a noncontrolled, open-label clinical trial of azithromycin 250?mg once daily for 3?months in patients with pulmonary sarcoidosis who reported a chronic cough. The primary outcome was number of coughs in 24?h. Secondary outcomes were cough visual analogue scales and quality of life measured using the Leicester Cough Questionnaire and King's Sarcoidosis Questionnaire. Safety outcomes included QTc interval on ECG. Measurements were made at baseline and after 1 and 3?months of treatment.

Results:All 21 patients were white, median age 57?years, 9 males, 12 females, median 3 years since diagnosis. Five were taking oral corticosteroids and none were taking other immunosuppressants. Twenty patients completed the trial. The median (range) number of coughs in 24?h was 228 (43-1950) at baseline, 122 (20-704) at 1?month, and 81 (16-414) at 3 months (p=0.002, Friedman's test). The median reduction in cough count at 3?months was 49.6%. There were improvements in all patient-reported outcomes. Azithromycin was well tolerated.

Conclusion:In a noncontrolled open-label trial in people with sarcoidosis who reported a chronic cough, 3?months of treatment with azithromycin led to improvements in a range of cough metrics. Azithromycin should be tested as a treatment for sarcoidosis cough in a randomised placebo-controlled trial.

SUBMITTER: Fraser SD

PROVIDER: S-EPMC7682709 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Azithromycin for sarcoidosis cough: an open-label exploratory clinical trial.

Fraser Simon D SD Thackray-Nocera Susannah S Shepherd Marica M Flockton Rachel R Wright Caroline C Sheedy Wayne W Brindle Kayleigh K Morice Alyn H AH Kaye Paul M PM Crooks Michael G MG Hart Simon P SP

ERJ open research 20201001 4

<h4>Background</h4>Chronic cough is a distressing symptom for many people with pulmonary sarcoidosis. Continuous treatment with a macrolide antibiotic may improve cough. We aimed to assess the potential efficacy of azithromycin in patients with sarcoidosis and self-reported cough.<h4>Methods</h4>We conducted a noncontrolled, open-label clinical trial of azithromycin 250 mg once daily for 3 months in patients with pulmonary sarcoidosis who reported a chronic cough. The primary outcome was number ...[more]

PMID: 33263056

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Project description:BackgroundThe rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory state leading to severe COVID-19 disease. Azithromycin is a macrolide antibiotic, known for its immunomodulatory properties. It has shown antiviral effect specifically against SARS-CoV-2 in vitro and acts on cytokine signaling pathways that have been implicated in COVID-19.MethodsDAWn-AZITHRO is a randomized, open-label, phase 2 proof-of-concept, multicenter clinical trial, evaluating the safety and efficacy of azithromycin for treating hospitalized patients with COVID-19. It is part of a series of trials testing promising interventions for COVID-19, running in parallel and grouped under the name DAWn-studies. Patients hospitalized on dedicated COVID wards are eligible for study inclusion when they are symptomatic (i.e., clinical or radiological signs) and have been diagnosed with COVID-19 within the last 72 h through PCR (nasopharyngeal swab or bronchoalveolar lavage) or chest CT scan showing typical features of COVID-19 and without alternate diagnosis. Patients are block-randomized (9 patients) with a 2:1 allocation to receive azithromycin plus standard of care versus standard of care alone. Standard of care is mostly supportive, but may comprise hydroxychloroquine, up to the treating physician's discretion and depending on local policy and national health regulations. The treatment group receives azithromycin qd 500 mg during the first 5 consecutive days after inclusion. The trial will include 284 patients and recruits from 15 centers across Belgium. The primary outcome is time from admission (day 0) to life discharge or to sustained clinical improvement, defined as an improvement of two points on the WHO 7-category ordinal scale sustained for at least 3 days.DiscussionThe trial investigates the urgent and still unmet global need for drugs that may impact the disease course of COVID-19. It will either provide support or else justify the discouragement of the current widespread, uncontrolled use of azithromycin in patients with COVID-19. The analogous design of other parallel trials of the DAWN consortium will amplify the chance of identifying successful treatment strategies and allow comparison of treatment effects within an identical clinical context.Trial registrationEU Clinical trials register EudraCT Nb 2020-001614-38 . Registered on 22 April 2020.

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Azithromycin for sarcoidosis cough: an open-label exploratory clinical trial.

Publications

Azithromycin for sarcoidosis cough: an open-label exploratory clinical trial.

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