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    Summary
    EudraCT Number:2019-004182-41
    Sponsor's Protocol Code Number:7774
    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:2019-12-02
    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 number2019-004182-41
    A.3Full title of the trial
    Chronic airway disease, mucus rheology and exacerbations: a randomized controlled trial of COPD patients (COPD-CARhE)
    Maladie chronique des voies respiratoires, rhéologie du mucus et exacerbations : un essai contrôlé randomisé chez les patients atteints de BPCO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chronic airway disease, mucus rheology and exacerbations: a randomized controlled trial of COPD patients (COPD-CARhE)
    Maladie chronique des voies respiratoires, rhéologie du mucus et exacerbations : un essai contrôlé randomisé chez les patients atteints de BPCO COPD-CARhE
    A.3.2Name or abbreviated title of the trial where available
    (COPD-CARhE)
    (COPD-CARhE)
    A.4.1Sponsor's protocol code number7774
    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 SponsorUniversity hospital of Montpellier
    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 supportUniversity hospital of Montpellier
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity hospital of Montpellier
    B.5.2Functional name of contact pointAnne CADENE
    B.5.3 Address:
    B.5.3.1Street Address32-39, avenue Charles Flahault ,Hôpital La Colombière
    B.5.3.2Town/ cityMONTPELLIER
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number+33467330814
    B.5.5Fax number+33467339172
    B.5.6E-maila-cadene@chu-montpellier.com
    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 holderPFIZER HOLDING FRANCE
    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 nameAZITHROMYCIN
    D.3.4Pharmaceutical form Film-coated 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COPD (CHRONIC OBSTUCTIVE PULMONARY DISEASE)
    BPCO (BRONCHOPATHIE PULMONAIRE CHRONIQUE OBSTRUCTIVE)
    E.1.1.1Medical condition in easily understood language
    COPD (CHRONIC OBSTUCTIVE PULMONARY DISEASE)
    BPCO (BRONCHOPATHIE PULMONAIRE CHRONIQUE OBSTRUCTIVE)
    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
    The main objective is to compare exacerbation rates over 12 months of follow-up between 1 group of patients with COPD treated according to standardized management (azithromycin prescribed for severe sputum) and 1 similar group in which the Azithromycin is prescribed depending on the rheology of the patient's mucus.
    L’objectif principal est de comparer les taux d'exacerbations sur 12 mois de suivi entre 1 groupe de patients atteints de BPCO traités selon une prise en charge standardisée (azithromycine prescrite en cas d’expectorations sévères selon le score CASA-Q, bras comparateur standardisé) et 1 groupe similaire dans lequel l'azithromycine est prescrite en fonction de la rhéologie du mucus des patients (groupe expérimental).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare between the 2 arms:
    • exacerbation rates according to their severity;
    • changes in symptoms, mucus rheology, and lung function;
    • medication use and adverse events;
    • trajectories of patients during follow-up;
    • overall clinical improvement and quality of life;
    • evolution of biomarkers of interest.
    Les objectifs secondaires sont de comparer entre les 2 bras :
    • les taux d’exacerbation selon leur sévérité ;
    • l’évolution des symptômes, de la rhéologie du mucus, et de la fonction pulmonaire ;
    • la consommation de médicaments et les évènements indésirables ;
    • les trajectoires des patients pendant le suivi ;
    • l’amélioration clinique globale et la qualité de vie ;
    • l’évolution de biomarqueurs d’intérêt.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Between 40 and 85 years old
    • Signed informed consent form
    • Subjects must be able to attend all scheduled visits and comply with all testing procedures
    • Beneficiary of the French social security system
    • Man or woman with COPD for at least 1 year defined according to the GOLD criteria and validated by the clinical investigator
    • Optimal treatment according to GOLD recommendations Grade of severity C or D
    •  1 exacerbation in the last 12 months
    • Spontaneous or induced sputum production
    • ECG: QTc <450 ms in man, QTc<470 ms in woman
    • Normal Audiogram
    • Entre 40 et 85 ans inclus
    • Formulaire de consentement éclairé signé
    • Les sujets doivent être en mesure d'assister à toutes les visites prévues et de se conformer à toutes les procédures d'essai
    • Bénéficiaire du système de sécurité sociale français
    • Homme ou femme avec BPCO depuis au moins 1 an défini selon les critères GOLD et validé par l'investigateur clinique
    • Traitement optimal selon les recommandations GOLD classe de sévérité C ou D
    •  1 exacerbation au cours des 12 derniers mois
    • Production spontanée ou induite d’expectoration
    • ECG: QTc <450 ms chez l'homme, QTc<470 ms chez la femme

    • Audiogramme normal
    E.4Principal exclusion criteria
    • Pregnancy or breastfeeding
    • Patients who are prisoners or other forms of judicial protection
    • Patients under any form of tutorship / curatorship
    • The patient participates in another interventional protocol, or did so in the month prior to inclusion
    • Received azithromycin in the previous 3 months
    • History of allergy or intolerance to macrolides / azithromycin
    • Concomitant medication incompatible with azithromycin
    • Other respiratory diseases or associated lung infections
    • History of severe hepatic impairment (a liver function test will be performed if clinical suspicion)
    • Grossesse ou allaitement
    • Les patients qui sont prisonniers ou sous d'autres formes de protection judiciaire
    • Patients sous toute forme de tutelle/curatelle
    • Le patient participe à un autre protocole interventionnel, ou l'a fait au cours du mois précédent l'inclusion
    • A reçu de l’azithromycine au cours des 3 mois précédents
    • Antécédents d'allergie ou d'intolérance aux macrolides / azithromycine
    • Médicament concomitant incompatible avec l'azithromycine
    • Autres maladies respiratoires ou infections pulmonaires associées
    • Antécédent connu d’insuffisance hépatique sévère (un bilan biologique hépatique sera réalisé si suspicion clinique)
    E.5 End points
    E.5.1Primary end point(s)
    The number of exacerbations observed during the 12 month follow-up period.
    Le critère de jugement principal est le nombre d’exacerbations pendant 12 mois de suivi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 MONTHS
    12 MOIS
    E.5.2Secondary end point(s)
    Secondary endpoints are:
    • The number of exacerbations according to their severity, as well as the evolution of symptoms
    • The rheology of mucus
    • Pulmonary function
    • Medication consumption
    • Exacerbation episodes and hospitalizations, as well as associated symptoms / treatments
    • The clinical improvement is scored via a point system from 0 to 3.
    • Questionnaires SF-36, EQ-5D-5L, SGRQ (quality of life).
    The biomarkers of interest will be evaluated at baseline and at the end of the study:
    • complete blood counts, including neutrophils, eosinophils,
    • Serum club cell secretory protein
    • Bacteriology in the sputum
    Patient safety will be ensured through a collection of adverse events throughout the duration of the study.
    Les critères de jugement secondaires sont :
    • Le nombre d’exacerbations selon leurs sévérité, ainsi que l’évolution des symptômes
    • La rhéologie du mucus
    • La fonction pulmonaire
    • La consommation de médicaments
    • Les épisodes d’exacerbation et les hospitalisations, ainsi que les symptômes/traitements associés
    • L’amélioration clinique est cotée via un système de points de 0 à 3.
    • Les questionnaires SF-36, EQ-5D-5L, SGRQ (qualité de vie).
    Les biomarqueurs d’intérêt seront évalués à l’état de base et en fin d’étude :
    • Numération sanguine complète, y compris neutrophilie, éosinophilie,
    • Serum club cell secretory protein
    • Bactériologie dans l'expectoration
    La sécurité des patients sera assurée via un recueil des évènements indésirables pendant toute la durée de l’étude.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 MONTHS
    12 MOIS
    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 Yes
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    Dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-12-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state72
    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)
    after the end of the study the standard treatement protocole will be reinstaured
    après la fin de l'étude la prise en charge standard se réinstaure pour la totalité des patients
    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 Decision2021-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-14
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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