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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-001227-13
    Sponsor's Protocol Code Number:SOPAZITHRO
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-11-19
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2020-001227-13
    A.3Full title of the trial
    Evaluation of the Efficacy of 3-month Continuous Extended Treatment With Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults: a Multicentre Randomised Controlled Trial
    Evaluation de l’efficacité du traitement prolongé continu de 3 mois par l’azithromycine dans les sinusites oedémato-purulentes idiopathiques de l’adulte : essai multicentrique contrôlé randomisé en double aveugle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults
    A.4.1Sponsor's protocol code numberSOPAZITHRO
    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 SponsorCentre hospitalier intercommunal de Créteil
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre hospitalier intercommunal de Créteil
    B.5.2Functional name of contact pointCoordinating investigateur
    B.5.3 Address:
    B.5.3.1Street Address40 avenue de Verdun
    B.5.3.2Town/ cityCréteil
    B.5.3.3Post code94000
    B.5.3.4CountryFrance
    B.5.4Telephone number57022612+33
    B.5.5Fax number157022849+33
    B.5.6E-mailcrcpromotion@chicreteil.fr
    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 AZITHROMYCINE MYLAN 250 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAZITHROMYCINE
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Purulent Oedematous Sinusitis
    Patients présentant une rhinosinusite chronique diffuse purulente
    E.1.1.1Medical condition in easily understood language
    Patients with Purulent Oedematous Sinusitis
    Patients présentant une rhinosinusite chronique diffuse purulente
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10060841
    E.1.2Term Sinusitis bacterial
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10009137
    E.1.2Term Chronic sinusitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary endpoint was the comparison of the means of the SNOT 22 specific quality of life scores assessed at the end of the 3 months of treatment.
    Le critère de jugement principal est la comparaison des moyennes des scores de qualité de vie spécifique SNOT 22 évalués à la fin des 3 mois de traitement.
    E.2.2Secondary objectives of the trial
    - Compare the efficacy of azithromycin DDLC to placebo at 3 months on
    o The number of infectious rhinosinus exacerbations
    o The number of courses of antibiotics administered
    o Intensity of functional symptomatology
    o Endoscopic examination results
    o CT score of rhinosinus opacities before treatment and after 3 months of treatment
    o Ciliary beat before treatment and after 3 months of treatment
    o The degree of nasal inflammation
    o Bacterial colonization
    o General quality of life
    o Absenteeism from work
    - To evaluate the compliance and tolerance of the treatment (clinical and biological tolerance
    - Evaluate the remanence of the treatment at 6 months on the quality of life, the symptomatology, the nasal endoscopy and the bacteriological sampling.
    - To evaluate the clinico-biological predictive factors of response to treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient older than 18 years and less than 70 years of age
    Chronic rhinosinusitis (> 12 weeks of evolution) meeting the definition published in the European Paper Position2012 (1) and corresponding exclusively to the following endoscopic and CT criteria:

    Nasal endoscopy showing bilateral and diffuse involvement associating edema of the mucosa of the nasal cavities and meatus with the presence of mucopurulent secretions in these areas
    Nasosinus CT scan showing diffuse and bilateral pansinus opacities involving at least the maxillary sinuses and the anterior and posterior ethmoids
    Persistent intractable purulent rhinosinusitis despite at least 2 antibiotic therapies
    Signed informed consent of the patient
    Membership in a health insurance plan or beneficiary
    E.4Principal exclusion criteria
    Pregnancy or breastfeeding
    POS of identified primary cause (identified immune deficiency, cystic fibrosis)
    Chronic non-purulent rhinosinusitis (nasosinusal polyposis, allergic rhinosinusitis)
    Localized chronic suppurative rhinosinusitis (single sinus, unilateral)
    Severe hepatic insufficiency
    Severe renal insufficiency
    Severe cardiac insufficiency
    Documented moderate pre-existing hearing loss (>30dB) or single ear (unilateral cophosis)
    Major cognitive impairment or lack of French language skills preventing completion of SNOT-22 and SF-36 questionnaires
    Allergy to lactose
    Long QT on ECG (>440ms for men and >450ms for women) or cardiac arrhythmia or bradycardia (<60btm)
    Hypokalemia or hypomagnesemia on blood ionogram
    Allergy to macrolides
    Confirmed or suspected atypical mycobacteriosis (tuberculosis)
    Contraindicated drug combinations with macrolides (antivitamins K or drugs containing cisapride, colchicine, ergotamine or dihydroergotamine)
    Cautionary drug combinations (non-inclusion criteria)

    Atorvastatin (Increased risk of concentration-dependent rhabdomyolysis-type adverse events due to decreased hepatic metabolism of the cholesterol-lowering drug.
    Ciclosporin (risk of increase in ciclosporin blood levels and creatinine levels)
    Digoxin
    Drugs likely to cause torsades de pointes, in particular class anti-hypertensive and class III antiarrhythmics, antipsychotics, tricyclic antidepressants, certain fluoroquinolones
    Simvastatin (increased risk of rhabdomyolysis-type adverse effects (concentration-dependent), due to decreased hepatic metabolism of the cholesterol-lowering agent).
    Patient under guardianship or curators
    Lactose intolerant patient
    Participation in other category 1 research
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of the means of the SNOT 22 specific quality of life scores after 3 months of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    E.5.2Secondary end point(s)
    The secondary endpoints studied were
    - The number of infectious rhinosinus exacerbations during the 3-month period,
    - The number of courses of antibiotics used during the 3-month period other than azithromycin or placebo,
    - Visual analog scales (VAS) of symptoms (self-assessment) (nasal obstruction, rhinorrhea, facial pain, smell disorder, nasal hyperactivity, epistaxis) (0 = absent, 10 = maximum felt),
    - Semi-quantitative 4-point symptom scale assessed by the practitioner
    - Semi-quantitative nasal endoscopy score (0: absent/1: present) for each of the following items: presence of pus, edema, erythema, crusts, polyps, scored out of 5 per nasal cavity (maximum score of 10) (Lund Kennedy score),
    - Quantitative Lund MacKay CT score (0: no sinus opacity, 1: moderate opacity, 2: total opacity) measured on 12 for each side (score of 24 maximum),
    - Nasal inflammation (nasal nitric oxide (NO) flow, neutrophil (NPC) and lymphocyte infiltrate on nasal cytology and assays of interleukin 6, 8 and elastase produced by NPCs in nasal secretions) (assayed in one center only),
    - General quality of life Short form-36 (SF-36),
    - Number of days off work in the 3 months prior to treatment and the number of days off work during the 3 months of treatment
    - Olfactory score (Sniffin's stick test),
    - Identification and quantification of bacteria present on the protected nasal swab (semi-quantitative score 1: rare/ 2: a few/ 3: many /4 very many colonies),
    - Compliance will be evaluated by the effective intake of tablets and clinical and biological tolerance (ECG, tonal audiometry, ALAT, ASAT),
    - At 6 months (i.e. 3 months after stopping treatment), the residual effect of the treatment will be measured solely on the SNOT22 and SF36 quality of life questionnaires, the VAS of symptoms by the patient, the semi-quantitative scale of symptoms (practitioner), nasal endoscopy and bacteriological sampling. The time to relapse will also be evaluated
    - The ciliary beat (quantitative aspect (frequency of the beat in Hertz), and qualitative (coordination (normal or dyskinetic), index of efficiency)) on a small number of centers having the equipment
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 or 6 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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    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
    Last follow-up visit of the last patient being followed
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months37
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 230
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    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 state230
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    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)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-22
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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