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    Summary
    EudraCT Number:2015-002733-22
    Sponsor's Protocol Code Number:MB0515/1021/03
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-04-03
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-002733-22
    A.3Full title of the trial
    Combined treatment with pidotimod and bifidobacteria in pre-scholastic age children with recurrent respiratory infections: evaluation of clinical efficacy and parents' quality of life
    TRATTAMENTO COMBINATO CON PIDOTIMOD E BIFIDOBATTERI IN BAMBINI IN ETÀ PRESCOLARE CON INFEZIONI RESPIRATORIE RICORRENTI: VALUTAZIONE DELL’EFFICACIA CLINICA E DELLA QUALITÀ DI VITA DEI GENITORI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with pidotimod and bifidobacteria in children with respiratory infections
    Trattamento con pidotimod e bifidobatteri in bambini con infezioni respiratorie
    A.3.2Name or abbreviated title of the trial where available
    MB0515/1021/03
    MB0515/1021/03
    A.4.1Sponsor's protocol code numberMB0515/1021/03
    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 SponsorVALEAS SPA - INDUSTRIA CHIMICA E FARMACEUTICA
    B.1.3.4CountryItaly
    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 supportVALEAS S.p.a.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVALEAS SPA
    B.5.2Functional name of contact pointClinical Department
    B.5.3 Address:
    B.5.3.1Street AddressVia Vallisneri, 10
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number0223690215
    B.5.5Fax number022367500
    B.5.6E-maildir.medica@valeas.it
    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 AXIL - 400 MG/7 ML SOLUZIONE ORALE 10 CONTENITORI MONODOSE DA 7 ML
    D.2.1.1.2Name of the Marketing Authorisation holderPOLICHEM S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameAXIL 400 mg/7 ml soluzione orale
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent respiratory infections
    Infezioni respiratorie ricorrenti
    E.1.1.1Medical condition in easily understood language
    Respiratory infections
    Infezioni respiratorie
    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 PT
    E.1.2Classification code 10062352
    E.1.2Term Respiratory tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate in pre-scholastic age children with recurrent respiratory infections the effects of the treatment with pidotimod and/or bifidobacteria on the prevention of respiratory infections.
    Valutare nei bambini con IRR in età prescolare gli effetti del trattamento con pidotimod e/o bifidobatteri sulla prevenzione delle infezioni respiratorie.
    E.2.2Secondary objectives of the trial
    To evaluate both the duration and the intensity of respiratory infections, the QUolity of Life of parents, the tolerability and safety of the treatments.
    Valutare sia la durata che l’intensità delle IR, la Qualità di Vita dei genitori, la tollerabilità e sicurezza dei trattamenti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Children:
    - both sex aged 3-6 years;
    - integrated in scholastic ambient (nursery school, kindergarten);
    - affected by recurrent respiratory infections defined as:
    .. 6 or more episodes in the previous year: 01/10/2014 - 30/09/2015;
    .. 1 or more episodes/month in the period september-april of the previous year: 01/09/2014 - 20/054/2015;
    .. 3 or more lower respiratory tract infections in the previous year: 01/10/2014 - 30/09/2015;
    - whose parents have given the appropriate consent to the study partecipation of their son.
    Bambini:
    - di ambo i sessi di età compresa 3-6 anni;
    - inseriti in ambiente scolastico (asilo nido, scuola materna);
    - affetti da infezioni respiratorie ricorrenti (IRR) definite come:
    .. 6 o più episodi nell'anno precedente: 01/10/2014 - 30/09/2015;
    .. 1 o più episodi/mese nel periodo settembre-aprile dell'anno precedente: 01/09/2014 - 20/04/2015;
    .. 3 o più infezioni delle vie aeree inferiori nell'anno precedente: 01/10/2014 - 30/09/2015;
    - i cui genitori abbiano espresso validamente il loro consenso alla partecipazione allo studio del proprio figlio.
    E.4Principal exclusion criteria
    - ongoing respiratory infection or other infections requiring hospitalization;
    - story of bronchospasm;
    - cardiopathies or severe systemic disease;
    - chronic respiratory diseases (like cystic fibrosis and primary ciliary dyskinesia);
    - immunodeficiencies;
    - treatment in the last 4 weeks with probiotics, corticosteroids, immunostimulants or immunosuppressants;
    - allergies or intolerance to pidotimod.
    - infezione respiratoria in atto o altre infezioni che richiedano ospedalizzazione;
    - storia di broncospasmo;
    - cardiopatie o patologie sistemiche gravi;
    - patologie respiratorie croniche (come fibrosi cistica e discinesia ciliare primitiva);
    - immunodeficienze;
    - trattamento nelle 4 settimane precedenti con probiotici, corticosteroidi, immunostimolanti o immunosoppressori;
    - allergie o intolleranze al pitotimod.
    E.5 End points
    E.5.1Primary end point(s)
    Number of respiratory infections
    Numero di infezioni respiratorie
    E.5.1.1Timepoint(s) of evaluation of this end point
    At sixth month
    Al sesto mese
    E.5.2Secondary end point(s)
    In relation to the respiratory infection episodes only:
    - Duration of the episodes
    - Days of treatment with antibiotic
    - Nr. of visits to the Doctor
    - Nr. of entries to the Emergency Room
    - Nr. and duration of hospitalizations
    - Nr. of days of absence from school
    - Nr. of days of absence from work for parents
    - Nr. of hours of baby sitting required

    Questionnaire on Quality of Life of parents
    Relativamente ai soli episodi di IR:
    - Durata degli episodi
    - Giorni di trattamento con antibiotico
    - N° di visite dal Medico
    - N° di accessi al Pronto Soccorso
    - N° e durata di ricoveri ospedalieri
    - N° di giorni di assenza da scuola
    - N° di giorni di assenza dal lavoro dei genitori
    - N° di ore di Baby Sitter richieste

    Questionario sulla Qualità della vita dei genitori
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    A sei mesi
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    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: 1
    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: 116
    F.1.1.6Adolescents (12-17 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors
    Minori
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state116
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 116
    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
    Nessuno
    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 Decision2015-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
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