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    Summary
    EudraCT Number:2013-000737-12
    Sponsor's Protocol Code Number:LPI-1201
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-11
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-000737-12
    A.3Full title of the trial
    The Influence of Polyvalent Mechanical Bacterial Lysate (ISMIGEN®) on Clinical Course of Asthma and Related Immunological parameters in Asthmatic Children (EOLIA Study): Randomized, Double Blind, Placebo-Controlled, Multicentre, Parallel-Group Study
    Wpływ poliwalentnego mechanicznego lizatu bakteryjnego (Ismigen®) na przebieg kliniczny astmy i związane z tym parametry immunologiczne u dzieci z astmą (badanie EOLIA). Randomizowane, podwójnie zaślepione, kontrolowane placebo, wieloośrodkowe badanie prowadzone w grupach równoległych.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Influence of Polyvalent Mechanical Bacterial Lysate (ISMIGEN®) on Clinical Course of Asthma and Related Immunological parameters in Asthmatic Children (EOLIA Study): Randomized, Double Blind, Placebo-Controlled, Multicentre, Parallel-Group Study
    Wpływ poliwalentnego mechanicznego lizatu bakteryjnego (Ismigen®) na przebieg kliniczny astmy i związane z tym parametry immunologiczne u dzieci z astmą (badanie EOLIA). Randomizowane, podwójnie zaślepione, kontrolowane placebo, wieloośrodkowe badanie prowadzone w grupach równoległych.
    A.3.2Name or abbreviated title of the trial where available
    EOLIA (Efficacy Of bacterial Lysate In Asthmatic children)
    Skuteczność lizatu bakteryjnego u dzieci z astmą.
    A.4.1Sponsor's protocol code numberLPI-1201
    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 SponsorLallemand Pharma International AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLallemand Pharma International AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinStart
    B.5.2Functional name of contact pointMarzanna Tomicka
    B.5.3 Address:
    B.5.3.1Street Addressul.Zagrodnicza 20
    B.5.3.2Town/ cityPoznań
    B.5.3.3Post code61-654
    B.5.3.4CountryPoland
    B.5.4Telephone number48618 266 027
    B.5.5Fax number48618 266 000
    B.5.6E-mailmarzanna.tomicka@clinstart.eu
    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 ISMIGEN
    D.2.1.1.2Name of the Marketing Authorisation holderLallemand Pharma Europe
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSublingual tablet
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    IgE-dependent asthma (diagnosis of asthma according to the GINA definition) in a paediatric population (6 thru 16 years old)
    astma IgE zależna(rozpoznanie według definicji GINA) w populacji pediatrycznej (6-16 lat)
    E.1.1.1Medical condition in easily understood language
    Allergic Asthma
    astma alergiczna
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the improvement versus placebo of the asthma control level as measured by the mean ACT (Asthma Control Test) score after administration of a Polyvalent Mechanical Bacterial Lysate (PMBL - Ismigen®) as add-on to routine asthma treatment
    Wykazanie poprawy w porównaniu z placebo w zakresie stopnia kontroli astmy na podstawie średniego wyniku testu ACT (test kontroli astmy) po podaniu poliwalentnego mechanicznego lizatu bakteryjnego (PMBL - Ismigen®) jako terapii dodanej do standardowego leczenia astmy.
    E.2.2Secondary objectives of the trial
    - To demonstrate the decrease in number of asthma exacerbations, and increase in time to first asthma exacerbation after administration of Ismigen®.
    - To demonstrate the decrease in number of respiratory tract infections during the Ismigen® treatment period and a 6 months follow-up after treatment in comparison with the pre-treatment period (according to medical history).
    - To demonstrate specific changes in a panel of immunological parameters in a biology subset of patients.
    - To demonstrate an improvement in the quality of life of patients.
    - wykazanie zmniejszenia liczby epizodów zaostrzenia astmy oraz wydłużenia czasu do wystąpienia pierwszego zaostrzenia astmy po podaniu preparatu Ismigen®.
    - wykazanie zmniejszenia liczby zakażeń dróg oddechowych w okresie leczenia preparatem Ismigen® i w ciągu 6-miesięcznego okresu obserwacji po zakończeniu leczenia w porównaniu z 6-miesięcznym okresem przed rozpoczęciem leczenia (na podstawie wywiadu chorobowego).
    - wykazanie specyficznych zmian w panelu parametrów immunologicznych w podgrupie pacjentów poddanych ocenie biologicznej
    -wykazanie poprawy jakości życia pacjentów
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Children of both genders aged 6 to 16 years.
    2. Allergic asthma diagnosis with at least one perennial allergen according to the Global Strategy for Asthma Management and Prevention (GINA 2012 guidelines) prior to screening visit.
    3.Patient shows clinical characteristics of partly controlled or uncontrolled asthma according to GINA 2012.
    4. Already treated with SABA prn and ICS or ICS + LABA during the previous 3 months.
    5. Patient shows asIgE against HDM ≥ class 2 or positive skin prick test or RAST for at least one perennial allergen.
    6. Patient who had at least 2 exacerbations of asthma within the 12-mo period before V1.
    7. Patient not treated with Polyvalent Mechanical Bacterial Lysate (Ismigen®) within the previous 6 months prior to V1.
    1. dzieci obu płci w wieku od 6 do 16 lat.
    2. rozpoznanie astmy alergicznej z uczuleniem na co najmniej jeden całoroczny alergen, według zaktualizowanej wersji wytycznych „Światowa strategia rozpoznawania, leczenia i prewencji astmy” GINA z 2012 r. (GINA), którą leczono co najmniej 12 miesięcy przed wizytą przesiewową.
    3. pacjent wykazujący cechy kliniczne częściowo kontrolowanej lub niekontrolowanej astmy według wytycznych GINA z 2012r.
    4. uprzednie leczenie za pomocą SABA (krótko działającego β2-mimetyku) podawanego zależnie od potrzeb (prn) i ICS (wziewnego glikokortykosteroidu) lub ICS + LABA (długo działającego β2-mimetyku) w ciągu poprzednich 3 miesięcy
    5. u pacjenta występują swoiste przeciwciała IgE (as-IgE), co potwierdzono wynikiem oznaczenia ≥ klasa 2 lub dodatnim wynikiem punktowego testu skórnego lub testu RAST dla co najmniej jednego alergenu całorocznego
    6. u pacjenta wystąpiły co najmniej 2 epizody zaostrzenia astmy w ciągu 12 miesięcy poprzedzających wizytę V1
    7. pacjent nie był uprzednio leczony za pomocą poliwalentnego mechanicznego lizatu bakteryjnego (Ismigen®) w ciągu 6 miesięcy poprzedzających wizytę V1
    E.4Principal exclusion criteria
    1. Patient received mechanical or any other bacterial lysate immunostimulation within the previous 6 months before V1.
    2. Patient received oral/subcutaneous allergen-immunotherapy within the previous 6 months before V1.
    3. History of near fatal asthma (e.g. brittle asthma, hospitalization for asthma exacerbation in Intensive Care Unit).
    4. Pregnant or breastfeeding woman.
    1. u pacjenta stosowano immunostymulację za pomocą mechanicznego lub innego lizatu bakteryjnego w ciągu 6 miesięcy poprzedzających wizytę V1.
    2. u pacjenta stosowano doustną/podskórną immunoterapię alergenową w ciągu 6 miesięcy poprzedzających wizytę V1.
    3. stwierdzone w wywiadzie epizody astmy zagrażającej życiu (np. astma chwiejna, hospitalizacja na oddziale intensywnej opieki medycznej z powodu zaostrzenia astmy ).
    4. ciąża lub karmienie piersią.
    E.5 End points
    E.5.1Primary end point(s)
    The main criterion is defined as the target improvement in asthma control level as measured by the mean ACT (Asthma Control Test) or P-ACT (Pediatric Asthma Control Test) score at 3 months.
    Główne kryterium jest zdefiniowane jako docelowa poprawa stopnia kontroli astmy na podstawie średniego wyniku testu ACT (Asthma Control Test) lub PACT (Pediatric Asthma Control Test) w ciągu 3 miesięcy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The product dependent progressive improvement in ACT/P-ACT score will be recorded throughout the study period at 3-month intervals during the study (at end of treatment and during a 6-month follow-up).
    Zależna od produktu postępująca poprawa w wynikach testu ACT/P-ACT
    będzie rejestrowana w odstępach 3-miesięcznych przez okres trwania badania ( na koniec leczenia i podczas 6- miesięcznej obserwacji).
    E.5.2Secondary end point(s)
    1. The number of respiratory infections occurring during the 3-mo Ismigen® treatment and the 6-mo follow-up after treatment.
    2. The time to first mild or severe asthma exacerbation will be reported.
    3. Standardized mean daily dose of ICS used during the whole study.
    4. The frequency of short acting beta-2 agonists use as rescue medication will be reported throughout the study.
    5. Blood levels of immunological parameters.
    6. Quality of life endpoints: the PAQLQ (Paediatric Asthma Quality of Life Questionnaire and PACQLQ (Paediatric Asthma Caregivers Quality of Life Questionnaire) will be scored at the end of the study in comparison with the baseline prior to treatment
    7. The cumulative number of days with respiratory tract infections will be reported during the whole study.
    8. The number of lost school days due to respiratory infections as well as to asthma exacerbations will be reported during the whole study period.
    1. Ilość jnfekcji dróg oddechowych występujących w trakcie 3-
    miesięcznego leczenia przy użyciu Ismigenu® i w ciągu 6-miesięcznej obserwacji po leczeniu.
    2. Czas do pierwszego umiarkowanego lub ciężkiego zaostrzenia astmy będzie raportowany na podstawie dodatkowych leków p-astmatycznych .
    3. Średnia dobowa dawka ICS stosowanego w trakcie całego badania.
    4. Częstość podawania SABA jako leku ratunkowego przez cały okres badania.
    5. Stężenie parametrów immunologicznych we krwi.
    6. Kwestionariusz jakości życia dzieci z astmą PAQLQ (Paediatric Asthma Quality of Life Questionnaire i kwestionariusz jakości życia opiekunów dzieci z astmą -PACQLQ (Paediatric Asthma Caregivers Quality of Life Questionnaire) będzie uzupełniany na zakończenie badania i porównywany z okresem sprzed leczenia.
    7. Łączna liczba dni z infekcją dróg oddechowych będzie raportowna przez cały okres badania.
    8. Liczba dni nieobecności w szkole z powodu infekcji dróg oddechowych jak również zaostrzeń astmy będzie raportowana w trakcie całego badania
    E.5.2.1Timepoint(s) of evaluation of this end point
    These end-points will be evaluated throughout the study period at 3-month intervals during the study (at end of treatment and during a 6-month follow-up).
    Item #5 will e assessed at baseline, 3 weeks and 3 months.
    Item #6 will be evaluated at the end of study only in comparison with baseline.
    Te punkty końcowe będą oceniane w trakcie badania w okresach co 3 miesiące (na koniec leczenia i w trakcie 6- miesięcznej obserwacji).
    Pkt 5 będzie oceniany na wizycie wyjściowej- baseline, w 3 tygodniu i 3 miesiącu
    Pkt 6 będzie oceniany na koniec leczenia w porównaniu z wizytą wyjściową -baseline.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 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 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
    End of trial is the last visit of last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 Yes
    F.1.1Number of subjects for this age range: 150
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 75
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 75
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Consent form (ICF) to be collected from parents/legally authorized representatives. Moreover:
    • For patients 12 and older, an adapted ICF will be collected.
    • For patients less than 12, a simplified ICF is provided and oral assent is collected.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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. Patients will continue their current routine treatment.
    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 Decision2013-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-08
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