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    Summary
    EudraCT Number:2017-003588-37
    Sponsor's Protocol Code Number:P150952J
    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:2020-09-14
    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 number2017-003588-37
    A.3Full title of the trial
    A randomized, placebo controlled, double blind, double dummy, multicenter trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine
    Etude randomisée, en double aveugle et à double placebo, multicentrique, nationale comparant la cigarette électronique à nicotine à la cigarette électronique sans nicotine et à la varénicline
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of electronic cigarettes for smoking cessation
    Utilisation de la cigarette électronique dans le sevrage tabagique
    A.3.2Name or abbreviated title of the trial where available
    ECSMOKE
    A.4.1Sponsor's protocol code numberP150952J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailcarla.vandenabele@aphp.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.2.1.1.2Name of the Marketing Authorisation holderPfizer
    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 nameVarenicline
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNChampix
    D.3.9.3Other descriptive nameChampix
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 placeboFilm-coated tablet
    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
    Smokers smoking at least 10 cigarettes/day in the past year
    Fumeurs fumant au moins 10 cigarettes par jour pendant l'année précédant l'inclusion
    E.1.1.1Medical condition in easily understood language
    smoking addiction
    Addiction au tabac
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10053325
    E.1.2Term Smoking cessation therapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of electronic cigarettes containing nicotine (ECwN) comparatively to an EC without nicotine (ECwoN) and to a reference, licensed smoking cessation medication: varenicline.
    Évaluer l'efficacité des cigarettes électroniques contenant de la nicotine (CE-N) comparativement à la CE sans nicotine (CE-Pl) et à un traitement de référence ayant une AMM dans le sevrage tabagique : la varénicline
    E.2.2Secondary objectives of the trial
    - To assess the safety profile of electronic cigarettes containing nicotine comparatively to its placebo and varenicline.
    - To assess the point prevalence abstinence: self-report of 7-day smoking abstinence at each visit associated with expired air CO ≤ 8 ppm.
    - To assess the time to relapse to smoking after the predefined target quit day
    - To study the change in cigarettes/day consumption
    - To study the change in craving for tobacco
    - To study the change in withdrawal symptoms
    1. Le profil d'effets indésirables de la CE-N par rapport à son placebo (CE-Pl) et à la varénicline.
    2.1. Taux d'abstinence ponctuelle de 7 jours : abstinence tabagique des 7 derniers jours précédant chaque visite.
    2.2. Temps écoulé entre la date d'arrêt de la consommation tabagique et la rechute.
    3.1. Changement de la consommation de cigarettes/jour
    3.2. Changement de désire impérieux de fumer
    3.3. Changement des symptômes de sevrage tabagique
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Smokers smoking at least 10 cigarettes/day (factory made or roll-your-own) in the past year
    2. Aged 18 to 70 years
    3. Motivated to quit defined as a score > 5 on a visual rating scale ranging from 0 (not motivated at all) to 10 (extremely motivated)
    4. Signed written informed consent
    5. Understanding and speaking French
    6. Women of childbearing age can be included if they use an effective contraceptive method: either hormonal contraception or an intrauterine device started at least one month before the first research visit
    7. Individual affiliated to a health insurance system as defined by the sponsor (except Aide Médicale d'État =AME)
    8. Previous failure of nicotine replacement therapy for smoking cessation
    1. Participant fumant au moins 10 cigarettes (manufacturées ou roulées) par jour depuis au moins 1 an
    2. Agés de 18 à 70 ans
    3. Motivé(e)s à arrêter de fumer défini par un score > 5 sur une échelle de notation visuelle allant de 0 (pas motivé du tout) à 10 (extrêmement motivé)
    4. Recueil du consentement écrit et éclairé
    5. Comprenant et parlant le français
    6. Les femmes en âge de procréer peuvent être inclues dans l'étude si elles utilisent une méthode contraceptive efficace: la contraception hormonale ou un dispositif intra-utérin a commencé au moins un mois avant la première visite de recherche
    7. Affilié(e)s à la Sécurité sociale ou à défaut, à un autre système d'assurance maladie sauf Aide Médicale d'État (AME)
    8. Echec antérieur d'un traitement par substitution nicotinique
    E.4Principal exclusion criteria
    1. any unstable disease condition within the last 3 months defined by the investigator as major change in symptoms or treatments, such as : see protocol
    2. any life threatening condition with life-expectancy of less than 3 months
    3. alcohol use disorder defined as a score ? 10 on the AUDIT-C questionnaire
    4. abuse of or dependence on illegal drugs in the last 6 months revealed by the medical history
    5. regular use of tobacco products other than cigarettes
    6. current or previous (last 6 months) use of electronic cigarette
    7. pregnant women
    8. breastfeeding women
    9. protected adults
    10. current or past 3 months participation in another interventional research
    11. current or past (last 3 months) use of smoking cessation medication such as varenicline, bupropion, nicotine replacement therapies
    12. known lactose intolerance (placebo tablets contain lactose)
    13. hypersensitivity to the active substance or to any of the excipients
    14. known severe renal failure
    15 person living in the same household as a participant already included
    1. Toute maladie instable grave au cours des 3 derniers mois définie par un changement majeur dans les symptômes ou les traitements, tels que : cf. protocole
    2. Toute atteinte engageant le pronostic vital du patient, dont l'espérance de vie est inférieure à 3 mois
    3. Abus ou dépendance à l'alcool (trouble d'usage de substances), défini par un score Audit-C ? 10
    4. Abus ou dépendance à une drogue (trouble d'usage de substances) au cours des 6 derniers mois et révélé lors de l'historique médical
    5. Utilisation régulière de produits de tabac autres que des cigarettes
    6. Utilisation actuelle ou passée (6 derniers mois) d'une cigarette électronique ou de tout autre système délivrant la nicotine
    7. Femme enceinte
    8. Allaitement maternel
    9. Personnes majeures protégées
    10. Participation à une autre recherche biomédicale au cours des 3 derniers mois précédant l'inclusion
    11. Utilisation actuelle ou passée (3 derniers mois) de médicament d'aide au sevrage tabagique tel que la varénicline, le bupropion ou des traitements de substitution nicotinique
    12. Intolérance au lactose connue (les comprimés placebo contiennent du lactose)
    13. Hypersensibilité à la substance active ou à l'un des excipients
    14. Insuffisance rénale sévère connue
    15. Personnes vivant sous le même toit qu’une autre personne déjà inclue
    E.5 End points
    E.5.1Primary end point(s)
    Main outcome measure: Continuous smoking abstinence rate during the last 4 weeks of a treatment period of 3 months.
    Critère principal d'efficacité: taux d'abstinence tabagique continu au cours des 4 dernières semaines d'une période de traitement de 3 mois.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semaines
    E.5.2Secondary end point(s)
    • The assessment criterion of the safety will be the comparison of serious adverse events and non-serious adverse events.
    • Point prevalence abstinence: self-report of 7-day smoking abstinence at each visit associated with expired air CO ≤ 8 ppm.
    • Time to relapse to smoking after the predefined target quit day
    • Change in cigarettes/day consumption
    • Change in craving for tobacco
    • Change in withdrawal symptoms


    -
    1. Le profil d'effets indésirables de la CE-N par rapport à son placebo (CE-Pl) et à la varénicline.
    2.1. Taux d'abstinence ponctuelle de 7 jours : abstinence tabagique des 7 derniers jours précédant chaque visite. 2.2. Temps écoulé entre la date d'arrêt de la consommation tabagique et la rechute.
    3.1. Changement de la consommation de cigarettes/jour 3.2. Changement de désire impérieux de fumer
    3.3. Changement des symptômes de sevrage tabagique
    E.5.2.1Timepoint(s) of evaluation of this end point
    25 weeks
    25 semaines
    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 No
    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) 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned13
    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 years3
    E.8.9.1In the Member State concerned months7
    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: 620
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 state650
    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 Decision2018-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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