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    Summary
    EudraCT Number:2009-013378-42
    Sponsor's Protocol Code Number:EBV09/01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-22
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-013378-42
    A.3Full title of the trial
    Double-blind, placebo-controlled, randomised clinical study of Broncho-Vaxom® drops in children suffering from recurrent Respiratory Tract Infections (RTIs)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Double-blind, placebo-controlled, randomised clinical study of Broncho-Vaxom® drops in children suffering from recurrent Respiratory Tract Infections
    A.3.2Name or abbreviated title of the trial where available
    Broncho-Vaxom® drops in children with recurrent RTIs
    A.4.1Sponsor's protocol code numberEBV09/01
    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 SponsorOM PHARMA SA
    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 supportOM PHARMA SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOM PHARMA SA
    B.5.2Functional name of contact pointClinical Project Coordinator
    B.5.3 Address:
    B.5.3.1Street Address22, rue du Bois-du-Lan
    B.5.3.2Town/ cityMeyrin
    B.5.3.3Post code1217
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4122783 1208
    B.5.5Fax number+41227831122
    B.5.6E-mailanne-sophie.racault@ompharma.com
    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 Broncho-Vaxom 11 mg/ml Oral solution
    D.2.1.1.2Name of the Marketing Authorisation holderOM PHARMA S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 nameBroncho-Vaxom® Drops
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Oral drops, solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameOM-85 concentrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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 placeboOral drops, solution
    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
    Recurrent respiratory tract infections
    E.1.1.1Medical condition in easily understood language
    Recurrent respiratory tract infections
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10038133
    E.1.2Term Recurrent respiratory tract infections
    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
    The objective of this study is to assess the efficacy and safety of Broncho-Vaxom® drops compared to placebo in children in reducing the severity and the rate of respiratory tract infections
    E.2.2Secondary objectives of the trial
    · Proportion of patients with recurrent respiratory tract infections (i.e. presenting 3 or more RTIs) up to the end of treatment period (V6).
    · Proportion of patients with at least one additional RTI up to the end of the study period (V7).
    · Proportion of patient suffering of gastro-intestinal infection during the treatment period.
    · Rate of gastro-intestinal infection during the treatment period
    · Severity of RTI symptoms with symptom score.
    · Duration of RTI.
    · Type and duration of concomitant treatment(s) with medication score
    · Proportion of patients suffering from viral (Influenza A and B, Respiratory Syncytial Virus (RSV)) or bacterial (ß-haemolytic Streptococcus A) infections detected with quick detection kits from nasal or throat swabs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Out-patient of either gender
    2) Patient aged between 12 months and 6 years (or in their 7th year)
    3) Patient known to his/her physician as suffering from recurrent RTI (documented respiratory tract infections, minimum 4 episodes during the year preceding the study period)
    4) Patient suffering from a RTI at the enrolment visit, according to one of the definitions under 2.2 (except rhinosinusitis, which does not respect the inclusion criterion 5).
    5) The beginning of this infection should not exceed 7 days prior to inclusion and has to occur after a steady period (without infection) of at least one week
    6) Patient whose parent(s) or legal representative have given their written informed consent
    E.4Principal exclusion criteria
    1) Patient with tonsillectomy and/or adenoidectomy if performed after the first RTI during the year preceding the study period
    2) Patient with allergic asthma
    3) Patient with mucoviscidosis
    4) Patient with known significant systemic disease, i.e. hepatic and/or renal disease
    5) Patient with malignant disease
    6) Patient with auto-immune disease and other systemic diseases related to immune system disorders
    7) Patient with diseases of the gastro-intestinal tract which would impair absorption of the study medication
    8) Patient with a known allergy or previous intolerance to the study medication
    9)Patient treated with the following medications:
    ♦ systemic antibiotics within one week before study start
    ♦ oral vaccination with live vaccine within 4 weeks before study start
    ♦ previous and/or concomitant immunosuppressive or immunostimulating therapy within 3 months before study start
    ♦ concomitant treatment with systemic corticosteroids for more than 10 consecutive days.
    ♦ concomitant treatment with any other investigational drug within 1 month before study start.
    10)Patient whose parents or legal representatives are unable to comply with the rules of this clinical study, especially if they do not accept intermediary phone calls (IPCs)
    11)Participation in another clinical trial within 1 month prior to study start.
    12)Subject with history of non-compliance with study medications or treatment protocol.

    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to asses the efficacy and safety of Broncho-Vaxom drops compared to placebo in children in reducing the severity and the rate of respiratory tract infections
    E.5.1.1Timepoint(s) of evaluation of this end point
    The end point will be evaluated after the last patient out
    E.5.2Secondary end point(s)
    The secondary efficacy variable is
    - the mean rate of RTI up to the end of the treatment period (V6), i.e. mean of the total number of RTIs per patient.
    -the proportion of patients with at least one additional RTI up to the end of the study period (V7)
    -the proportion of patients suffering from gastro-intestinal infection during the treatment period.
    -Rate of gastro-intestinal infection during the treatment period
    -the severity of RTI symptoms with symptom score
    -Duration of RTI
    -Type and duration of concomitant treatment(s)with medication score
    -proportion of patients suffering from viral or bacterial infections detected with quick detection kits from nasal or throat swabs
    E.5.2.1Timepoint(s) of evaluation of this end point
    The end point will be evaluated after the last patient out
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    The end of trial is the last visit of the 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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 278
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 278
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 278
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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
    Children aged of one to six years will be included, the written consent has to be given by the parent(s)or legal representatives, respectively.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 278
    F.4.2.2In the whole clinical trial 278
    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)
    After completion of the trial, no continuation supplies will be made available for the patients as with this indication no further treatment after the end of the trial is expected to be necessary. However, if a treatment is necessary the investigator will treat the patient until the respiratory tract infection is resolved, as usual.

    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 Decision2010-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-17
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