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Azithromycin a Treatment for Pulmonary Sarcoidosis (CAPS)

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ClinicalTrials.gov Identifier: NCT04020380
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hull and East Yorkshire 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 Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 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

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

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 ClinicalTrials.gov identifier (NCT number): NCT04020380


Contacts
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Contact: Simon Hart, MD 01482 624067 s.hart@hull.ac.uk
Contact: Caroline Wright, Bsc 01482 624067 c.e.wright@hull.ac.uk

Locations
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United Kingdom
Respiratory Medicine Clinical trials Unit Recruiting
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Contact: Caroline e wright, BSc    44 1482 624067    c.e.wright@hull.ac.uk   
Principal Investigator: Simon Hart, MD         
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Investigators
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Principal Investigator: Simon Hart, MD Hull and East Yorkshire Hospitals NHS Trust

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Responsible Party: Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04020380     History of Changes
Other Study ID Numbers: SARC2019
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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