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    Summary
    EudraCT Number:2019-000580-24
    Sponsor's Protocol Code Number:
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-03-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2019-000580-24
    A.3Full title of the trial
    A single arm, open-label clinical trial of azithromycin in pulmonary sarcoidosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of the antibiotic azithromycin for patients with sarcoidosis
    A.3.2Name or abbreviated title of the trial where available
    Azithromycin for sarcoidosis
    A.4.1Sponsor's protocol code number
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHull & East Yorkshire Hospitals NHS trust
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSarcoidosisUK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHull York Medical School/ University of Hull
    B.5.2Functional name of contact pointDr Simon Hart
    B.5.3 Address:
    B.5.3.1Street AddressAcademic Respiratory Medicine
    B.5.3.2Town/ cityCastle Hill Hospital
    B.5.3.3Post codeHU16 5JQ
    B.5.4Telephone number01482624067
    B.5.6E-mails.hart@hull.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Azithromycin
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAzithromycin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNazithromycin monohydrate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sarcoidosis
    E.1.1.1Medical condition in easily understood language
    Sarcoidosis is a chronic inflammatory disease of unknown cause that commonly affects the lungs, lymph nodes, eyes, and skin, and sometimes the bones, heart and nervous system.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the effect of azithromycin on cough measured using automated cough counting
    E.2.2Secondary objectives of the trial
    Assess the effect of azithromycin on :
    • Cough visual analogue score (VAS)
    • Leicester cough questionnaire (LCQ)
    • King’s Sarcoidosis Questionnaire (KSQ)
    • Clinical measurement as part of NHS care in the Sarcoidosis clinic over the study period will be recorded. Spirometry, chest x-ray, serum ACE, CRP are routinely measured. Progressive disease requiring escalation of therapy with steroids will be determined in the standard way by clinical MDT consensus.
    • Exploratory variables in blood samples:
    a) Anti-inflammatory activity of azithromycin assessed by cytokine release in an ex vivo whole blood assay
    b) Engagement of drug with target by measuring mTOR activation in peripheral blood mononuclear cells.
    • Variability of outcomes described above to inform statistical power calculations and determine sample size for a future RCT
    • Feasibility assessment for a multicentre trial of long term azithromycin therapy in sarcoidosis by measuring screening success rates, recruitment, attrition, an
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females, of any race, between 18 and 80 years of age, inclusive;
    2. Able to speak, read, and understand English;
    3. Able to provide written informed consent;
    4. Able to communicate effectively with the Investigator and other study centre personnel and agree to comply with the study procedures and restrictions.
    5. Clinician diagnosis of pulmonary sarcoidosis;
    6. 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;
    E.4Principal exclusion criteria
    1. Hypersensitivity to azithromycin or another macrolide antibiotic (e.g. erythromycin, clarithromycin) or excipients
    2. History of signficant cardiac arrhythmia
    3. Personal or family history of congenital long QT syndrome;
    4. Prolonged QTc interval on 12–lead ECG
    5. Severe liver disease
    6. Evidence of acute bacterial infection
    7. Clinically significant bronchiectasis
    8. Requiring concomitant therapy with prohibited medications (see Section 7.5)
    9. Pregnant or breastfeeding;
    10. 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;
    11. 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.
    E.5 End points
    E.5.1Primary end point(s)
    Cough assessed by:

    - Hull Automated Cough Counter (HACC) with the Leicester software algorithm

    Coughs will be counted over a 24-hour period after visits 1,2, and 3 using a digital portable cough counter that has been shown to be reliable and reproducible in counting coughs in a variety of conditions and settings. This cough counter discriminates cough from other sounds by analysing cough sounds acoustically. The cough counter will be returned or collected for analysis following visits 1, 2, and 3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 1 month, 3 months
    E.5.2Secondary end point(s)
    Cough visual analogue score (VAS)
    Leicester cough questionnaire (LCQ).
    King’s Sarcoidosis Questionnaire (KSQ)
    Clinical measurement as part of NHS care in the Sarcoidosis clinic over the study period will be recorded. Spirometry, chest x-ray, serum ACE, CRP are routinely measured. Progressive disease requiring escalation of therapy with steroids will be determined in the standard way by clinical MDT consensus.
    Blood will be analysed for exploratory variables:
    a) Anti-inflammatory activity of azithromycin assessed by cytokine release in an ex vivo whole blood assay
    b) Engagement of drug with target by measuring mTOR activation in peripheral blood mononuclear cells.
    •Variability of outcomes described above to inform statistical power calculations and determine sample size for a future RCT
    •Feasibility assessment for a multicentre trial of long term azithromycin therapy in sarcoidosis by measuring screening success rates, recruitment, attrition, and data quality.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 1 month, 3 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Azithromycin is a cheap, generic drug. There is an option to continue prescription 'off label' at the discretion of the supervising clinician if a meaningful benefit were observed for an individual participant during the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-05-01
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