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    Summary
    EudraCT Number:2018-000597-29
    Sponsor's Protocol Code Number:2017-02-CHRMT
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-26
    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 number2018-000597-29
    A.3Full title of the trial
    Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis
    Intérêt des tests de provocation nasale dans la sélection des patients devant bénéficier d’une immunothérapie spécifique aux acariens
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic, comparative and multicenter study aimed at evaluating the effectiveness of Nasal Provocation Test in allergen immunotherapy treatments
    Etude diagnostique, comparative et multicentrique visant à évaluer l’efficacité du test de provocation nasal parmi les traitements par immunothérapie allergénique
    A.3.2Name or abbreviated title of the trial where available
    NPT-MAR
    NPT-MAR
    A.4.1Sponsor's protocol code number2017-02-CHRMT
    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 Régional Metz-Thionville
    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 supportMinistère de la santé / DGOS/ GIRCI Est
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPlateforme d’appui à la recherche clinique
    B.5.2Functional name of contact pointArpiné EL NAR
    B.5.3 Address:
    B.5.3.1Street Address1 allée du Château
    B.5.3.2Town/ cityMetz
    B.5.3.3Post code57085
    B.5.3.4CountryFrance
    B.5.4Telephone number00330387557766
    B.5.5Fax number00330387557764
    B.5.6E-maila.elnar@chr-metz-thionville.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 (IMP1) AllergoPharma - Provokations Testlösung 725 Dermatophagoides pteronyssinus (5.000 SBE/ml)
    D.2.1.1.2Name of the Marketing Authorisation holderAllergopharma (Germany)
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameNasal provocation test – 725 Dermatophagoides Pteronyssinus
    D.3.4Pharmaceutical form Lyophilisate and solvent for nasal drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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
    mite allergenic rhinitis
    Rhinite allergique aux acariens
    E.1.1.1Medical condition in easily understood language
    mite allergenic rhinitis
    Rhinite allergique aux acariens
    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
    To compare the positive predictive value of the combination rapid nasal provocation test (TPNR) + skin tests (TC) + specific immunoglobulins E (IgEs) to the combination of TC + IgEs (strategy currently used in clinical practice) concerning the efficacy of treatment with Allergen immunotherapy (ITA) at 1 year, in patients with symptoms suggesting allergic rhinitis to house dust mites.
    Comparer la valeur prédictive positive de la combinaison test de provocation nasale rapide (TPNR) + tests cutanés (TC) + Immunoglobulines E spécifiques (IgEs) à la combinaison TC + IgEs (stratégie actuellement utilisée en pratique clinique) concernant l’efficacité du traitement par immunothérapie allergénique (ITA) à 1 an, chez des patients ayant des symptômes faisant évoquer une rhinite allergique aux acariens.
    E.2.2Secondary objectives of the trial
    • To assess the sensitivity, specificity and predictive values of the TPNR + TC + IgEs combination concerning the efficacy of treatment with allergenic immunotherapy (ITA) at 1, 2 and 3 years
    • To Compare the positive predictive value of the combination of TPNR + TC + IgEs to the combination of TC and IgEs (strategy currently used in clinical practice) concerning the efficacy of treatment with allergenic immunotherapy (ITA) at 2 years and at 3 years
    • To study the concordance of the evaluation of the symptoms of rhinitis at the time of diagnosis and at 1, 2 and 3 years by Visual Analogue Scale (VAS), by the CSMS (combined Symptom Medication score) and by the Lebel score.
    • Compare the effecticacy of ITA at 1, 2 and 3 years with the quality of life score (RQLQ questionnaire).
    • Evaluer la sensibilité, la spécificité et les valeurs prédictives de la combinaison TPNR + TC + IgEs concernant l’efficacité du traitement par immunothérapie allergénique (ITA) à 1, 2 et 3 ans
    • Comparer la valeur prédictive positive de la combinaison TPNR + TC + IgEs à la combinaison TC et IgEs (stratégie actuellement utilisée en pratique clinique) concernant l’efficacité du traitement par immunothérapie allergénique (ITA) à 2 ans et à 3 ans
    • Etudier la concordance de l’évaluation des symptômes de la rhinite au moment du diagnostic et à 1, 2 et 3 ans par EVA, par le score CSMS et par le score de Lebel.
    • Comparer l’efficacité de l’ITA à 1, 2 et 3 ans au score de qualité de vie (questionnaire RQLQ).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient over 18 years old,
    • Patient with persistent mild to severe or moderate to severe intermittent rhinitis according to ARIA criteria, suspicion of allergic rhinitis to dust mites, and a positive skin test for mites and / or a positive mite specific IgE assay
    • Patient having signed a free and informed consent
    • Patient de plus de 18 ans,
    • Patient présentant une rhinite persistante légère à sévère ou intermittente modérée à sévère selon les critères ARIA, suspicion de rhinite allergique aux acariens, et un test cutané positif aux acariens et/ou un dosage des IgE spécifiques aux acariens positifs
    • Patient ayant signé un consentement libre et éclairé
    E.4Principal exclusion criteria
    • Pregnant or breastfeeding women
    • Patients under guardianship or curatorship
    • Patients under legal protection
    • Patients not affiliated to a social security scheme
    • Contraindications to performing a RNPT
    o Active ENT or respiratory infections.
    o Allergy in acute phase.
    o History of anaphylaxis due to the allergen involved.
    o Unstabilized asthma and other obstructive pathologies.
    o Severe general illnesses in evolution.
    o Hypersensitivity to one of the components of the product
    o Simultaneous treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors,
    o Presence of an excessive degree of sensitization (e.g. history, excessive skin reactions),
    • Contraindications to immunotherapy:
    o Asthma (uncontrolled)
    o Active autoimmune diseases
    o Malignant tumors
    o Pregnancy (initiation of venereal disease)
    o AIDS
    • Femmes enceintes ou allaitantes
    • Patients sous tutelle ou curatelle
    • Patients sous sauvegarde de justice
    • Patients non affilié à un régime de sécurité sociale
    • Contre-indications à la réalisation d’un TPNR
    o Infections ORL ou respiratoires actives.
    o Allergie en phase aiguë.
    o Antécédents d’anaphylaxie à l’allergène en cause.
    o Asthme non stabilisé et autres pathologies obstructives.
    o Maladies générales sévères en évolution.
    o Hypersensibilité à l'un des composants du produit
    o Traitement simultané avec des bêta-bloquants ou des inhibiteurs de l'enzyme de conversion,
    o Présence d'un degré excessif de sensibilisation (par exemple anamnèse, réactions cutanées excessives),
    • Contre-indications à l’immunothérapie :
    o Asthme (non contrôlé)
    o Maladies auto-immunes actives
    o Tumeurs malignes
    o Grossesse (mise en route de l’ITS)
    o SIDA
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is negative predictive value, calculated with the efficacy of ITA at 1 year as the gold standard. It corresponds to the number of patients for whom treatment with an ITA will have been effective at 1 year, divided by the number of patients who have received an ITA.
    It will be calculated on the one hand for patients with TC and / or IgEs positive (control strategy), and on the other hand for patients with TC and / or IgEs positive and TPNR positive (strategy under study).
    Le critère de jugement principal est la valeur prédictive négative, calculée avec pour gold standard l’efficacité de l’ITA à 1 an. Elle correspond au nombre de patients pour lesquels le traitement par ITA aura été efficace à 1 an, divisé par le nombre de patients ayant reçu une ITA.
    Elle sera calculée d’une part pour les patients ayant TC et/ou IgEs positifs (stratégie contrôle), et d’autre part pour les patients ayant TC et/ou IgEs positifs et TPNR positif (stratégie à l’étude).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The end of the clinical trial
    E.5.2Secondary end point(s)
    • Effectiveness of ITA at 2 and 3 years, according to the same methods as for the primary endpoint.
    • Negative predictive value of the TC + IgEs + TPNR strategy for the efficacy of ITA at 1, 2 and 3 years, according to the same methods as for the primary endpoint.
    • Evaluation of the symptoms of allergic rhinitis using the CSMS score at 1, 2 and 3 years
    • Assessment of symptoms of allergic rhinitis using Lebel score at 1, 2 and 3 years
    • Evaluation of the specific quality of life at 1, 2 and 3 years, using the RQLQ questionnaire.
    • Efficacité de l’ITA à 2 et 3 ans, selon les mêmes modalités que pour le critère de jugement principal (cf 8.1).
    • Valeur prédictive négative de la stratégie TC + IgEs + TPNR pour l’efficacité de l’ITA à 1, 2 et 3 ans, selon les mêmes modalités que pour le critère de jugement principal.
    • Evaluation des symptômes de la rhinite allergique par le score CSMS à 1, 2 et 3 ans
    • Evaluation des symptômes de la rhinite allergique par le score de Lebel à 1, 2 et 3 ans
    • Evaluation de la qualité de vie spécifique à 1, 2 et 3 ans, par le questionnaire RQLQ.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The end of the clinical trial
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned4
    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
    LVLS
    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 months54
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state85
    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 Decision2021-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-30
    P. End of Trial
    P.End of Trial StatusCompleted
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