Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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. Identifier: NCT04020380
Recruitment Status : Completed
First Posted : July 16, 2019
Last Update Posted : July 16, 2020
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Sarcoidosis, Pulmonary Drug: Azithromycin 250Mg Capsule Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single centre, open label study
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
Experimental: Azithromycin 250 mg
Azithromycin, 250 mg capsules once a day for a total of 3 months
Drug: Azithromycin 250Mg Capsule
250 mg OD

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • • Males or females, of any race, between 18 and 80 years of age, inclusive;

    • Able to speak, read, and understand English;
    • Able to provide written informed consent;
    • Able to communicate effectively with the Investigator and other study centre personnel and agree to comply with the study procedures and restrictions.
    • Clinician diagnosis of pulmonary sarcoidosis;
    • If a female of child-bearing potential (i.e., have not undergone a hysterectomy or bilateral oophorectomy) or not post-menopausal (defined as no menses for at least 12 months), agree to use acceptable birth control (defined in Section 6.3) from screening through to the follow up visit;

Exclusion Criteria:

  • • Hypersensitivity to azithromycin or another macrolide antibiotic (e.g. erythromycin, clarithromycin) or excipients (see 7.4)

    • History of signficant cardiac arrhythmia
    • Personal or family history of congenital long QT syndrome;
    • Prolonged QTc interval on 12-lead ECG
    • Signficant liver disease
    • Evidence of acute bacterial infection
    • Clinically significant bronchiectasis
    • Requiring concomitant therapy with prohibited medications (see Section 7.5)
    • Pregnant or breastfeeding;
    • Treatment with an investigational drug or biologic within 30 days preceding the first dose of study medication or plans to take another investigational drug or biologic within 30 days of study completion;
    • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the subject inappropriate for entry into this trial.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04020380

Layout table for location information
United Kingdom
Respiratory Medicine Clinical trials Unit
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust
Layout table for investigator information
Principal Investigator: Simon Hart, MD Hull University Teaching Hospitals NHS Trust
Layout table for additonal information
Responsible Party: Hull University Teaching Hospitals NHS Trust Identifier: NCT04020380    
Other Study ID Numbers: SARC2019
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoidosis, Pulmonary
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents