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    Summary
    EudraCT Number:2009-017257-35
    Sponsor's Protocol Code Number:R015
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-12-04
    Trial 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 - BfArM
    A.2EudraCT number2009-017257-35
    A.3Full title of the trial
    Multi-center, randomized, double-blind, placebo-controlled, cross-over Phase II study to evaluate the safety and efficacy of inhaled Bimosiamose for the treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
    A.4.1Sponsor's protocol code numberR015
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRevotar Biopharmaceuticals AG
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameBimosiamose
    D.3.2Product code Bimosiamose
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBimosiamose
    D.3.9.1CAS number 187269-40-5
    D.3.9.2Current sponsor codeBimosiamose
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboNebuliser solution
    D.8.4Route of administration of the placeboInhalation 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)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the safety and efficacy of Bimosiamose for the treatment of male and postmenopausal or sterile female patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
    E.2.2Secondary objectives of the trial
    Comparison: Day 28 (end of active treatment period) vs. Day 28 (end of placebo treatment period) for:
    • MMP-9 in induced sputum supernatant
    • MPO in induced sputum supernatant
    • lymphocytes, eosinophils and macrophages (percentage and abs. numbers) and neutrophils (percentage) in induced sputum
    • pre- and post-bronchodilator FEV1
    • pre- and post-bronchodilator FVC
    • pre- and post-bronchodilator PEF
    • pre- and post-bronchodilator IC

    Comparison between active and placebo treatment: Change from baseline (Day 28 – Day 0 of the particular treatment period) for:
    • absolute neutrophil cell counts
    • IL-8 in induced sputum supernatant
    • MPO in induced sputum supernatant
    • MMP-9 in induced sputum supernatant
    • lymphocytes, eosinophils and macrophages (percentage and abs. numbers) and neutrophils (percentage) in induced sputum
    • pre- and post-bronchodilator FEV1
    • pre- and post-bronchodilator FVC
    • pre- and post-bronchodilator PEF
    • pre- and post-bronchodilator IC
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Amendment 2 to study protocol
    "Multi-center, randomized, double-blind, placebo-controlled, cross-over Phase II study
    to evaluate the safety and efficacy of inhaled Bimosiamose for the treatment of patients
    with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)"


    Objective: obtaining more detailed information on sputum cellular
    composition, e.g. differentiation of lymphocyte subpopulations.
    E.3Principal inclusion criteria
    • Male and postmenopausal or sterile female patients with a history of moderate to severe COPD defined as GOLD II-III for at least 1 year
    • At least 40 years of age
    • Current smoker or ex-smoker with at least 10 pack-year smoking history
    • Postbronchodilator FEV1 between 30 % and 80 % predicted and FEV1/FVC ratio < 70%. Postbronchodilator refers to 30 min after inhalation of 400 µg Salbutamol
    • Able to produce sputum upon induction in a sufficient quality.
    • Time and ability to complete the study
    • Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
    E.4Principal exclusion criteria
    • Patients with a history of chronic respiratory disorders other than COPD e.g. asthma, α1-Antitryspsin deficiency, mucoviscidosis, lung fibrosis
    • Patients who experienced an exacerbation in the 4 weeks before the start of the study or between screening and randomization
    • Patients who experienced an acute upper respiratory tract infection or broncho-pulmonary infection requiring antibiotic treatment during the 4 weeks before the start of the study or between screening and randomization
    • Treatment with inhaled, topical or any systemic corticosteroids or theophylline within at least 4 weeks before screening and during the study period, patients on inhaled steroid and/or theophylline treatment will undergo a washout of at least 4 weeks prior to the screening visit after the informed consent has been signed
    • Investigational drug within at least 4 weeks or at least 5 half-lives of investigational drug before study entry or during the study period whichever is longer and/or participation in another clinical trial within 4 weeks prior to Visit 1 and/or during the entire course of the study
    • Treatment with systemic acting proteins and/or antibodies within at least 3 months before study entry or during the study period
    • Previous treatment with Bimosiamose
    • Known allergy to any of the components of Bimosiamose solution
    • Patients with diagnosis/treatment of cancer and/or immunosuppressive therapy (according to ATC class L04; different washout for oral corticosteroids) within 5 past years
    • Any condition which in the opinion of the investigator makes the patient unable to complete the study per protocol (e.g. patients not likely to stay in the study for 16 weeks because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable; or patients who have a concomitant condition that might confuse or confound study assessments)
    • Patients with severe allergies manifested by a history of anaphylaxis or who have a history of multiple allergies
    • Vaccination of any kind within 4 weeks prior to randomization and/or during the entire course of the study until completion of visit 8
    • Presence or history of a major chronic inflammatory autoimmune disease like psoriasis, psoriatic arthritis, rheumatoid arthritis, spondyloarthropathy, inflammatory bowel disease or systemic lupus erythematosus (SLE)
    • Positive result of HIV1/2 antibodies, HCV antibody or HBs antigen testing, evidence of acute Hepatitis A infection (anti-HAV-IgM positive)
    • History of drug or alcohol abuse within the 12 months prior to dosing or alcohol breath test positive at screening or positive drug screening in urine
    • gamma-GT≥3 times the upper limit of normal
    • Platelet count ≥10% below the lower limit of normal
    • Patients who are known or suspected
    - not to comply with the study directives
    - not to be reliable or trustworthy
    - not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
    - to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in
    • Patient is institutionalized because of legal or regulatory order
    • Re-entry of a patient who has been randomized already in this trial
    • Employee at the investigational site, relative or spouse of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    The difference in the absolute neutrophil cell counts and interleukin-8 (IL-8) in induced sputum between Bimosiamose and placebo treatment will be analyzed as alternative primary endpoints (Day 28 (end of active treatment period) vs. Day 28 (end of placebo treatment period)).
    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 Yes
    E.6.6Pharmacokinetic Yes
    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) 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 No
    E.8.1.6Cross over Yes
    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.8.3 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 concerned10
    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 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
    End of trial is defined per protocol as last patient last visit
    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 months9
    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 months0
    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 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.1.3Elderly (>=65 years) Yes
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state77
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 77
    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 Decision2010-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-17
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