Azithromycin a Treatment for Pulmonary Sarcoidosis (CAPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04020380|
Recruitment Status : Completed
First Posted : July 16, 2019
Last Update Posted : July 16, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoidosis, Pulmonary||Drug: Azithromycin 250Mg Capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single centre, open label study|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Open-label Exploratory Clinical Trial of Azithromycin in Pulmonary Sarcoidosis|
|Actual Study Start Date :||September 6, 2019|
|Actual Primary Completion Date :||June 20, 2020|
|Actual Study Completion Date :||June 20, 2020|
Experimental: Azithromycin 250 mg
Azithromycin, 250 mg capsules once a day for a total of 3 months
Drug: Azithromycin 250Mg Capsule
250 mg OD
- change in 24 hr cough counts from baseline [ Time Frame: 3 months ]24n hr cough monitoring with ambulatory cough monitor will be performed at baseline and at 1mth and 3 months post treatment
- Mean Change in severity of cough from baseline [ Time Frame: 3 months ]Severity of cough will be scored on a visual anolgue scale at baseline and at 1month and 3 months post treatment
- Mean Change in urge to cough from baseline [ Time Frame: 3 months ]Urge to cough will be scored on a visual analogue scale at baseline and at 1 month and 3 months post treatment
- Mean Change in Leicester cough questionnaire total score from baseline [ Time Frame: 3 months ]The Leicester cough questionnaire will be performed at baseline and at 1 month and 3 months post treatment.
- Mean Change in Kings sarcoidosis questionnaire total score from baseline [ Time Frame: 3 months ]Kings sarcoidosis questionniare will be completed at baseline and compared with that at 1 month and 3 months post azithromycin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020380
|Respiratory Medicine Clinical trials Unit|
|Cottingham, East Yorkshire, United Kingdom, HU16 5JQ|
|Principal Investigator:||Simon Hart, MD||Hull University Teaching Hospitals NHS Trust|