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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41039   clinical trials with a EudraCT protocol, of which   6717   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2012-000712-29
    Sponsor's Protocol Code Number:BV2012/05
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-11
    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 ConcernedGermany - PEI
    A.2EudraCT number2012-000712-29
    A.3Full title of the trial
    Clinical and immune modifying capacity of Broncho-Vaxom® tested by LPS challenge in healthy volunteers
    A randomized double-blind placebo-controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Broncho-Vaxom(R) ability to respond to the induction of inflammation through the inhalation of a bacterial component.
    Participants of the study will be assigned by chance to one of the treatment arms and Broncho-Vaxom(R) will be compared to a product with no treatment value (placebo). Neither the participants nor the study staff will know which subject receive Broncho-Vaxom(R) or the placebo.
    A.3.2Name or abbreviated title of the trial where available
    Broncho-Vaxom® immune-modifying capacity
    A.4.1Sponsor's protocol code numberBV2012/05
    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+41227831463
    B.5.5Fax number+41227831122
    B.5.6E-mailaude.chevalier@viforpharma.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 Erwachsene
    D.2.1.1.2Name of the Marketing Authorisation holderOM PHARMA S.A.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 placeboCapsule
    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
    healthy volunteers
    intended indication : Experimental induced bronchitis in healthy volunteers
    E.1.1.1Medical condition in easily understood language
    healthy volunteers
    intended indication : Experimental induced bronchitis in healthy volunteers
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10021832
    E.1.2Term Infection induced
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10006451
    E.1.2Term Bronchitis
    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 primary endpoint will be the change from baseline on secretory IgA level in saliva after 4 weeks of study treatment
    E.2.2Secondary objectives of the trial
    The secondary objective will be the reduction of the inflammatory response after LPS challenge:
    1. Leukocytes, Neutrophils, C-Reactive protein, Lipopolysaccharide-binding protein levels in serum
    2. Neutrophilic inflammation in induced sputum
    3. Bronchoconstriction (FEV1 decrease)
    4. Local symptoms like chest tightness cough
    5. Systemic effects like increase of body temperature, chills and headache
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Volunteers to be included in this study are those :
    - who have been informed of the study procedures and have given their written informed consent.
    - Healthy male and female of any race
    - aged 18 to 45 years
    E.4Principal exclusion criteria
    Volunteers to be excluded from this study are those :
    - who have received systemic or inhaled corticosteroids within 4 weeks of Visit 1
    - who have smoked on a regular basis within 2 years of Visit 1 or who have a smoking history > 10 pack years
    - with an active lung disease (e.g. asthma, chronic bronchitis, COPD)
    - who have suffered from a respiratory tract infection within the 4 weeks preceding the study period
    - with predicted FEV1 below 80% at visit 1
    - with clinically significant uncontrolled systemic disease or a history of such disease (e.g. cancer, infection, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinology or gastrointestinal disease) within the previous 3 months
    - with clinically significant laboratory abnormalities at Visit 1
    - with a platelet count ≤ 130 x 109/L at visit 1
    - with Methacholine-test below 0.1mg at V1
    - with a clinically significant abnormal finding detected on ECG
    at visit 1
    - with a skin prick test result >5mm and a corresponding history of allergic asthma
    - with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline of scretory IgA level in saliva after 4 weeks of treatment with Broncho-Vaxom®
    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)
    Reduction of the inflammatory response after a LPS inhalation challenge. The secondary endpoints supporting this objective will be the reduction on one of the following LPS-induced responses:
    1. Leukocytes, neutrophils, CRP, LPS-binding protein (LBP) levels in serum
    2. Neutrophilic inflammation and inflammatory cytokines in induced sputum
    3. Bronchoconstriction (FEV1 decrease)
    4. Local symptoms: cough, chest tightness
    5. Systemic effects like increase of body temperature, chills and headache.
    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 No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.2.3.1Comparator description
    2 doses of Broncho-Vaxom are tested in this trial, 7mg/day and 21mg/day
    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 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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 60
    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 Yes
    F.3.2Patients No
    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 state60
    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 condition is resolved.
    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 Decision2012-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
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