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    Summary
    EudraCT Number:2013-001940-71
    Sponsor's Protocol Code Number:BV2013/5
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-001940-71
    A.3Full title of the trial
    A Randomized, Placebo Controlled, Double Blinded, Mechanistic trial to investigate the effects of Broncho-Vaxom (OM-85 BV) on the innate immune system in patients with COPD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the effects of Broncho-Vaxom (OM-85 BV) on the immune system in patients with Chronic obstructive pulmonary disease
    A.3.2Name or abbreviated title of the trial where available
    OM-85-BV Mechanistic study in COPD
    A.4.1Sponsor's protocol code numberBV2013/5
    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 Research Department
    B.5.3 Address:
    B.5.3.1Street Address22, rue du Bois du Lan
    B.5.3.2Town/ cityMeyrin 2/Geneva
    B.5.3.3Post code1217
    B.5.3.4CountrySwitzerland
    B.5.6E-maillorenz.lehr@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
    D.2.1.1.2Name of the Marketing Authorisation holderOM Pharma SA
    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
    Chronic Obstructive Pulmonary Disease (COPD)
    E.1.1.1Medical condition in easily understood language
    Lung Disease
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of Broncho-Vaxom on the phagocytic ability of monocyte-derived macrophages (MDMs) in patients with COPD
    E.2.2Secondary objectives of the trial
    - To measure blood biomarkers, including CRP, fibrinogen, IL-6, immunoglobulins (i.e., IgG1, IgG2, IgG3, IgA, IgM)
    - To measure sputum biomarkers, including IL-1b, MPO, IL-8
    - To measure lower airway bacterial colonisation
    - To measure lung function by spirometry
    - To assess symptom scores/Patient reported outcomes including SGRQ, CAT, mMRC
    - To assess safety, including AEs, SAEs, vital signs, physical examinations and laboratory parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent prior to any study procedures
    2. Males and Females aged ≥40
    3. Confirmed spirometric evidence of mild to very severe COPD (stage I to IV) according to the WHO GOLD criteria; FEV1/FVC <70%
    4. Current or ex-smoker, with >10PYH (a pack year is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked eg. 10PYH is equal to smoking 20 cigarettes per day for 10 years or 40 cigarettes per day for 5 years)
    5. Vaccinated against seasonal influenza >7 days prior to enrolment
    6. History of Chronic Bronchitis
    7. Exacerbator phenotype – defined as 1 or more treated or untreated acute exacerbations of COPD, with infective component based on symptoms recorded on the patient’s diary card in the previous 12 months, appropriately documented in patients’ medical files
    E.4Principal exclusion criteria
    1. Suffering from asthma
    2. Any known neoplasia or malignancy
    3. Other significant respiratory disease such as primary bronchiectasis or mucoviscidosis
    4. Known chronic systemic infections or inflammatory conditions like Rheumatoid arthritis, Lupus or any other auto-immune disease
    5. Previous organ transplantation
    6. Myocardial infarction or cerebrovascular accident within the last 6 months prior to study enrolment
    7. Suffering from any respiratory infections within 4 weeks prior to study enrolment
    8. Any major surgery within the last 3 months prior to study enrolment
    9. Treatment with the following medications:
    a. antibiotics and systemic and oral steroids (e.g., oral prednisolone) within 4 weeks before Visit 1,
    b. oral vaccination with live vaccine within 4 weeks before Visit 1,
    c. long-term azithromycin therapy within 3 months before Visit 1,
    d. previous and/or concomitant immunosuppressive or immunostimulating therapy within 3 months before Visit 1
    10. Known allergy or previous intolerance to study medication
    11. Females who are pregnant or breast feeding
    12. Females of childbearing potential unwilling to use sufficiently reliable method of contraception for the period of the clinical trial
    13. Unable to follow instructions and unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorders as well as patients unwilling to abide by the requirements of the protocol, i.e. unable to complete a patient diary.
    14. Any other clinical conditions, that in the opinion of the investigator, would not allow safe completion of the clinical study
    15. Not willing or unable to give written informed consent
    16. Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or receiving other investigational agent(s).
    E.5 End points
    E.5.1Primary end point(s)
    Change in phagocytic ability of MDMs from baseline to Day 30 (Visit 3) as measured by challenge with fluorescently labelled dead bacteria, including:
    - Change in H influenzae bacteria concentration from baseline to Day 30
    - Change in S. pneumoniae bacteria concentration from baseline to Day 30
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 30
    E.5.2Secondary end point(s)
    1. Change in phagocytic ability of MDMs from baseline to Days 10 (Visit 2) and 60 (Visit 4)
    2. Phagocytic ability of MDMs after 10 and 30 days of treatment and after 30 days off treatment (Visit 4; Day 60)
    3. Blood biomarker levels, and changes from baseline at all visits: CRP, fibrinogen, IL-6, immunoglobulins (i.e., IgG1, IgG2, IgG3, IgA, IgM)
    4. Sputum biomarker levels, and changes from baseline at all visits: IL-1-b, MPO, IL-8
    5. Lower airway bacterial colonisation (as measured by qPCR and quantitative culture) – values and change from baseline at all visits
    6. Lung function (as measured by spirometry) – values and change from baseline at all visits
    7. Patient reported outcomes; CAT scores and change from baseline at all visits, SGRQ scores and change from baseline at Visit 3, mMRC scores
    8. Safety, including AEs, SAEs, vital signs, physical examination and laboratory parameters.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 10, Day 60
    2. Day 10, Day 30, Day 60
    3. Day 10, Day 30, Day 60
    4. Day 10, Day 30, Day 60
    5. Day 10, Day 30, Day 60
    6. Day 10, Day 30, Day 60
    7. Day 10, Day 30, Day 60
    8. Day 10, Day 30, Day 60
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Mechanism of action
    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 No
    E.8.2.4Number of treatment arms in the trial2
    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
    Last Visit Last Subject
    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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 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)
    Patients are part of the site cohort and are therefore followed up routinely with visits every 3 months
    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 Decision2013-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-31
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