Azithromycin for sarcoidosis cough: an open label exploratory clinical trial
- Simon D. Fraser1,
- Susannah Thackray-Nocera2,
- Marica Shepherd2,
- Rachel Flockton2,
- Caroline Wright1,2,
- Wayne Sheedy1,
- Kayleigh Brindle2,
- Alyn H. Morice1,
- Paul M. Kaye3,
- Michael G. Crooks1 and
- Simon P. Hart1⇑
- 1Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK
- 2Respiratory Clinical Trials Unit, Hull University Teaching Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK
- 3York Biomedical Research Institute, University of York, York, UK
- Dr S.P. Hart. E-mail: s.hart{at}hull.ac.uk
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 did a non-controlled, 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 analog 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 one 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 non-controlled 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.
Footnotes
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Conflict of interest: Dr. Fraser reports grants from SarcoidosisUK, during the conduct of the study.
Conflict of interest: Dr. Thackray-Nocera has nothing to disclose.
Conflict of interest: Dr. Shepherd has nothing to disclose.
Conflict of interest: R Flockton has nothing to disclose.
Conflict of interest: Dr. Wright has nothing to disclose.
Conflict of interest: Dr. Sheedy has nothing to disclose.
Conflict of interest: Dr. Brindle has nothing to disclose.
Conflict of interest: Dr. Morice has nothing to disclose.
Conflict of interest: Dr. Kaye reports grants from SarcoidosisUK, during the conduct of the study.
Conflict of interest: Dr. Crooks reports grants from Sarcoidosis UK, during the conduct of the study.
Conflict of interest: Dr. Hart reports grants from SarcoidosisUK, during the conduct of the study.
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- Received July 28, 2020.
- Accepted September 9, 2020.
- Copyright ©ERS 2020
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