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    Summary
    EudraCT Number:2017-003188-36
    Sponsor's Protocol Code Number:WI218780
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-14
    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 ConcernedFinland - Fimea
    A.2EudraCT number2017-003188-36
    A.3Full title of the trial
    Keski-ikäisten pitkään tupakoineiden tupakasta vieroitus sähkötupakalla
    ( Efficacy and safety of e-cigarettes for smoking cessation in middle-aged heavy smokers, EFFECT)

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Keski-ikäisten pitkään tupakoineiden tupakasta vieroitus sähkötupakalla
    Lapin sähkötupakkatutkimus
    A.3.2Name or abbreviated title of the trial where available
    EFFECT
    A.4.1Sponsor's protocol code numberWI218780
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03235505
    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 SponsorLapland Central Hospital
    B.1.3.4CountryFinland
    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 supportLapland Central Hospital
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLapland Central Hospital
    B.5.2Functional name of contact pointTuula Toljamo
    B.5.3 Address:
    B.5.3.1Street AddressOunasrinteentie 22
    B.5.3.2Town/ cityRovaniemi
    B.5.3.3Post code96440
    B.5.3.4CountryFinland
    B.5.4Telephone number+358407218759
    B.5.5Fax number+358163283011
    B.5.6E-mailtuula.toljamo@lshp.fi
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Champix in EU Chantix in US
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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 nameChampix
    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 INNvarenicline
    D.3.9.1CAS number 375815-87-5
    D.3.9.3Other descriptive nameVARENICLINE TARTRATE
    D.3.9.4EV Substance CodeSUB22601
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0,5 to 1,0
    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
    Nicotine addiction
    Pitkää tupakoineita aikuisia, joille on kehittynyt nikotiiniriippuvuus
    E.1.1.1Medical condition in easily understood language
    Nicotine addiction
    Nikotiiniriippuvuus
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10056478
    E.1.2Term Nicotine addiction
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study how heavy middle-aged smokers do succeed to quit smoking with e-cigarettes compared to using varenicline used according to Current Care guidelines
    Tutkia keski-ikäisillä pitkään tupakoineilla henkilöillä sähkötupakan avulla tupakasta vieroituksessa onnistumista verrattuna Käypä hoito-linjauksen mukaiseen tehokkaimpaan käytettävissä olevaan vieroituslääkkeeseen
    E.2.2Secondary objectives of the trial
    To study how heavy middle-aged smokers do succeed to reduce smoking with e-cigarettes compared to using varenicline according to Current Care guidelines
    Niiden tutkittavien osuus, jotka onnistuivat vähentämään tupakointiaan tutkimuksen aikana
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults (age 25 - < 75 years),
    - Smoked >10 years daily and are current smokers at least 10 cig/day for at least past five years
    - Exhale CO-level of at least 15ppm.
    - At least 5 or more points in the Fagerström Test for Nicotine -
    -Dependence or at least 3 or points in the Heaviness of smoking Index (HSI).
    - Good general health
    - Intent to quit smoking
    - Commit to follow the trial and could provide consent
    Keski-ikäiset (25v - alle 70v) päivittäin tupakoivat vapaaehtoiset aikuiset , joilla on keskivahva/ vahva nikotiiniriippuvuus tutkimuksen alkaessa ja jotka haluavat lopettaa tupakointinsa
    E.4Principal exclusion criteria
    - Non-daily smoker, pregnancy or gestation or intend to get pregnant
    during the follow-up
    - Current use of smoking cessation pharmacotherapy or smoking cessation
    during the past year
    - Use of e-cigarettes during the past year
    - Any active cancer.At least 5 healthy follow-up years after stopping the
    cancer therapy
    - Instable (ischemic) vascular or heart disease or recent myocardial
    infarction (3 months )
    - High blood pressure at rest (BP> 140mmHg and /or diastolic 90mmHg )
    - History of major psychiatric depression or other psychiatric conditions
    and daily use of psychiatric medicine
    - Current addiction of alcohol or misuse of substances
    - Inability to express himself/herself
    - Allergy to any of the study medications
    - Severe allergy, poorly controlled asthma or other pulmonary disease
    - Epilepsy
    - Satunnainen tupakointi
    - vaikeaa tai epästabiili sydän- tai verenkiertosairaus
    - vaikeaa muu sairaus
    - epilepsia
    - vaikea psyykkinen sairaus vaatien pävittäistä lääkitystä
    - aine- tai alkoholiriippuvuus
    - kyvyttömyys ilmaista itseään
    - herkistyminen joillekin käytettävistä vieroituslääkkeistä
    - sähkötupakan käyttö tutkimukseen tullessa
    - jokin vieroituslääke käytössä tutkimukseen tulless
    E.5 End points
    E.5.1Primary end point(s)
    We postulate that if the tested nicotine containing e-cigarettes treatment could increase the 24 weeks abstinence rate up to 20%, this would be clinically important.
    Tutkimuksella on kliinistä merkitystä vieroitustyössä, jos 20% tutkittavista on onnistunut 24 seurantaviikon käynnillä lopettamaan tupakointinsa
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 week visit
    24 seurantaviikon käynnillä
    E.5.2Secondary end point(s)
    24 week visit
    52 weeks visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    The prevalence of those participants who succeeded to decrease the number of daily cigarettes during the study
    52 seurantaviikkoa
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    commercially in EU affordable electronic cigarette
    E.8.2.4Number of treatment arms in the trial3
    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
    Tutkimus loppuu siinä vaiheessa kun LSLV
    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 months
    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: 420
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    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 2017-11-14. 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 state450
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 450
    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
    Tutkimuksen jälkeen jokaiselle tutkittavalle henkilökohtaisesti ilmoitetaan mihin tutkimusryhmään hän kuului.
    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 Decision2018-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
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