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    Summary
    EudraCT Number:2012-004491-18
    Sponsor's Protocol Code Number:BAY85-8501-16359
    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:2012-12-18
    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 number2012-004491-18
    A.3Full title of the trial
    A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis Bronchiectasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Oral BAY 85-8501 in Patients with inflammation of the tubes in the lungs.
    A.4.1Sponsor's protocol code numberBAY85-8501-16359
    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 SponsorBayer HealthCare 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 supportBAYER HEALTHCARE AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer Healthcare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team / Ref: "EU CTR" Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post codeD-13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 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 nameBAY 85-8501
    D.3.2Product code BAY 85-8501
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeBAY 85-8501
    D.3.9.3Other descriptive nameBAY 85-8501
    D.3.9.4EV Substance CodeSUB31335
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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) 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
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Non-Cystic Fibrosis Bronchiectasis
    E.1.1.1Medical condition in easily understood language
    Inflammation of the Lungs
    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 15.1
    E.1.2Level PT
    E.1.2Classification code 10006445
    E.1.2Term Bronchiectasis
    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 assess the safety and tolerability of 28 day oral administration of BAY 85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE)
    E.2.2Secondary objectives of the trial
    To examine the effect of BAY 85-8501 on pulmonary function, biomarkers of inflammation and tissue damage, and the impact on overall health and perceived well-being.

    To evaluate the pharmacokinetics of BAY 85-8501
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent
    2. Age ≥18 years
    3. Proven and documented diagnosis of non-CF idiopathic or post-infectious BE by HRCT scan including 2 or more lobes and dilated airways compatible with BE at initial diagnosis
    4. Stable pulmonary status as indicated by FEV1 percent predicted ≥30%and <90% (post-bronchodilator)
    5. If subjects are on a pulmonary training program, they must: 1) have been stable on the program for the 4 weeks prior to screening, and 2) continue the pulmonary training program throughout the entire study period
    6. Stable (i.e., no dose change) regimen of standard BE treatments, including treatment with hypertonic solutions, mucolytics, long-acting and short-acting β2-agonists and anticholinergic agents, inhaled corticosteroids, low dose systemic corticosteroids (≤10 mg/day prednisone equivalent) and regular physiotherapy for at least 4 weeks prior to screening. Low dose macrolides (as anti-inflammatory therapy) should be administered for at least 6 months prior to screening if used as chronic treatment for BE. These treatments are hereafter referred to as ‘standard BE treatment’
    7. Spontaneous sputum sample, assessed as purulent, per investigator judgement
    8. Cough and sputum production on most days. Subject must be able to produce an induced sputum sample at screening, which will be used for baseline biomarker assessment
    9. Ability to complete questionnaires
    10. Negative urine pregnancy test result for women of non-childbearing potential (WONCBP) before first dose of study drug
    11. Women of non-childbearing potential, defined as postmenopausal women, or permanently sterilized women (bilateral tubal ligation, bilateral ovariectomy, or hysterectomy. Women of childbearing potential (WOCBP) will not be entered into the study. Post-menopause is defined as having had no menses in the past 12 months,
    or
    Male subjects, with partners of childbearing potential, should use at least two forms of highly effective contraceptive methods, unless they agree to abstain from heterosexual intercourse while participating in the study. Highly effective contraception methods are the following: consistent use of oral, injected or implanted methods of contraception, intra-uterine device or intra-uterine system, barrier methods (condom, diaphragm, cervical cap) when used with spermicidal foam/gel/film/cream. Sterilized male participants will also need to use an additional contraception form. One (for sterilized males) or two (for non-sterilized males) of the following methods should be used during the study and continue for 3 months after the last follow-up visit
    a) Barrier methods of contraception (e.g., condom or occlusive cap (diaphragm or cervical/vault caps). The use of barrier contraceptives should always be supplemented with spermicidal foam/gel/film/cream/suppository
    b) Double-barrier methods of contraception (e.g., condom and occlusive cap with spermicidal foam/gel/film/cream/suppository)
    c) Intrauterine contraceptive device
    d) Approved pharmaceutical contraceptive product (e.g., birth control pills or patches, long-term injectable or implantable hormonal contraceptive).
    E.4Principal exclusion criteria
    1. FEV1 <30% or ≥90% predicted (post-bronchodilator)
    2. Pre-bronchodilator FEV1: difference between Screening (Visit 1) and Baseline (Visit 2) is ≥20%
    3. Recent significant hemoptysis (≥300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period)
    4. Known cystic fibrosis and/or documented chronic bronchial asthma
    5. Active allergic bronchopulmonary aspergillosis (ABPA)
    6. Diagnosis of common variable immunodeficiency (CVID)
    7. Systemic or inhaled antibiotic treatment within 4 weeks prior to screening
    8. Treatment of an exacerbation within 4 weeks prior to screening
    9. Treatment with immunomodulatory agents, within 8 weeks prior to screening and throughout the study (macrolides will be allowed to be used in the study, per conditions defined in Inclusion criteria #6)
    10. Systemic corticosteroids at >10 mg/day prednisolone equivalent for >2 weeks within 4 weeks prior to screening
    11. Treatment with moderate and strong Cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors within 1 week prior to screening (e.g., clarithromycin, erythromycin, telithromycin, ciprofloxacin, itraconazole, ketoconazole, voriconazole, posaconazole, fluconazole, grapefruit juice) (Note: this list is not all-inclusive, and investigator is referred to FDA website: [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm#potency])
    12. Treatment with moderate and strong CYP3A4 inducers within 2 weeks prior to screening (e.g., St. John’s Wort, rifampin, carbamazepine, phenytoin) (Note: this list is not all-inclusive, and investigator is referred to FDA website: [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm#potency])
    13. Administration of any investigational drug within 4 weeks before screening
    14. Previous assignment to treatment during this study
    15. Women of childbearing potential (WOCBP). Women who are pregnant, lactating, or in whom pregnancy cannot be excluded. Peri-menopausal women are excluded from participating in the protocol
    16. Subjects with a medical disorder, condition, or history of such that would impair the subject’s ability to participate or complete this study in the opinion of the investigator
    17. Subjects with a history of severe allergies or multiple drug allergies
    18. Subjects with hypersensitivity to the study drug or any of the excipients
    19. Subjects with a history of hypertonic saline intolerance
    20. Affiliation with personnel at the investigational site (e.g., a close friend or relative of the investigator, employee or student at the site).
    E.5 End points
    E.5.1Primary end point(s)
    Safety variables measured during the treatment and follow-up period and include physical exam, vital signs, 12-lead ECG, safety lab assessments (hematology, chemistry and urinalysis), and AEs, including SAEs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    E.5.2Secondary end point(s)
    1) Efficacy variables which are the changes from baseline by treatment in:
    Pulmonary function tests (FEV1, FVC, FEF25-75)
    SGRQ
    Sputum weight
    Biomarkers
    Sputum
    Blood
    Urine

    2. Pharmacokinetic variables: plasma concentrations at different time points
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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.
    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 Decision2013-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-13
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