Azithromycin a Treatment for Pulmonary Sarcoidosis
Status:
Completed
Trial end date:
2020-06-20
Target enrollment:
Participant gender:
Summary
Patients with sarcoidosis need treatment options that effectively control their disease
without causing undesirable side effects. An appealing strategy is to repurpose existing
drugs which possess beneficial immune modulating activity and are safe for long-term use.
Recently, increased activity of the mTOR intracellular signalling pathway in inflammatory
cells has emerged as a key driver of granulomatous inflammation in mouse models and patients
with sarcoidosis. The macrolide antibiotic azithromycin directly inhibits mTOR activity in
inflammatory cells, making it a prime target for drug repurposing in sarcoidosis.
Azithromycin has an acceptable tolerability profile when used for long-term treatment of
other chronic respiratory disease Single centre open label clinical trial of oral
azithromycin 250 mg once daily for 3 months in 20-30 patients with pulmonary sarcoidosis.
The Investigator have opted for an open label study because this will be the first study of
azithromycin in sarcoidosis. Trial assessments will be performed according to standards of
Good Clinical Practice with assessments at baseline, 1, and 3 months. All other clinical
care, investigations, and treatment (if indicated) will remain the responsibility of the
treating physician and based on clinical MDT consensus decisions.
Phase:
Phase 2
Details
Lead Sponsor:
Hull and East Yorkshire Hospitals NHS Trust Hull University Teaching Hospitals NHS Trust