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    The EU Clinical Trials Register currently displays   41235   clinical trials with a EudraCT protocol, of which   6758   are clinical trials conducted with subjects less than 18 years old.
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    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:2018-003205-25
    Sponsor's Protocol Code Number:BT–L-CsA–302–DLT
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-04
    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 ConcernedAustria - BASG
    A.2EudraCT number2018-003205-25
    A.3Full title of the trial
    A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.
    A.3.2Name or abbreviated title of the trial where available
    BOSTON-2
    A.4.1Sponsor's protocol code numberBT–L-CsA–302–DLT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03656926
    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 SponsorBREATH Therapeutics Inc.
    B.1.3.4CountryUnited States
    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 supportBREATH Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBREATH Therapeutics Inc.
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address633 Menlo Avenue #230
    B.5.3.2Town/ cityMenlo Park
    B.5.3.3Post codeCA 94025
    B.5.3.4CountryUnited States
    B.5.6E-mailcontact@breath-therapeutics.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/210
    D.3 Description of the IMP
    D.3.1Product nameLiposomal Cyclosporine A
    D.3.2Product code L-CsA
    D.3.4Pharmaceutical form Powder and solvent for nebuliser solution
    D.3.4.1Specific paediatric formulation No
    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 INNCiclosporin (Ciclosporinium)
    D.3.9.1CAS number 59865-13-3
    D.3.9.2Current sponsor codeL-CsA
    D.3.9.3Other descriptive nameCICLOSPORIN A
    D.3.9.4EV Substance CodeSUB129839
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation
    E.1.1.1Medical condition in easily understood language
    Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy and safety of add-on aerosolized L-CsA to Standard of Care therapy as compared to SoC therapy alone in the treatment of BOS in double lung transplant recipients.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients of ≥18 years who received a double lung transplant at
    least 12 months prior to Screening.
    2. Patients with clinically defined BOS (CLAD – BOS phenotype) with
    screening FEV1 between 85-60% of personal best FEV1 value post
    transplant.
    3. Patients in whom the diagnosis of BOS has been confirmed by the
    elimination of other possible causes of obstructive or restrictive lung
    disease (CLAD – RAS phenotype, see Protocol Specific Definitions).
    4. Patients with a diagnosis of BOS made at least 1 year after transplant
    surgery and within 12 months prior to the Screening Visit.
    5. Patients should be on a drug maintenance regimen of
    immunosuppressive agents including tacrolimus, a second agent such as
    but not limited to MMF or azathioprine, and a systemic corticosteroid
    such as prednisone as third agent. The regimen must be stable for at
    least 4 weeks prior to randomization with respect to the therapeutic
    agents.
    6. Patients must consent to retrieve prespecified data from the historic
    medical record (e.g., information related to the transplant surgery;
    spirometry data; medication use).
    7. Patients must be receiving or have received post-transplant
    prophylaxis against Cytomegalovirus (CMV) and Pneumocystis
    pneumonia as per SoC at the site.
    8. Patients capable of understanding the purposes and risks of the
    clinical trial, who have given written informed consent and agree to
    comply with the clinical trial requirements/visit schedules, and who are
    capable of aerosol inhalation.
    9. Women of childbearing potential must have a negative serum or urine
    pregnancy test within 7 days prior to randomization and must agree to
    use one of the methods of contraception listed in Appendix II through
    their End of Study Visit.
    10. Patients have no concomitant diagnoses that are considered fatal
    within one year (12 months) of Screening.
    E.4Principal exclusion criteria
    1. Patients with confirmed other causes for loss of lung function, such as
    acute infection, acute rejection, restrictive allograft syndrome (CLAD –
    RAS phenotype, see Protocol Specific Definitions),etc.
    2. Cystic Fibrosis patients with multi-drug resistant infections not
    responding to available anti-microbial therapies.
    3. Patients with acute antibody-mediated rejection at Screening. In this
    context, clinically stable patients (as judged by the Investigator) with
    detectable levels of donor specific antibodies (DSA) at the Screening
    Visit are eligible for the study.
    4. Active bacterial, viral, or fungal infection not successfully resolved at
    least 4 weeks prior to the Screening Visit. Patients with chronic
    infection or colonization who are clinically stable as per judgement of
    the Investigator are eligible for the study
    5. Mechanical ventilation within 12 weeks prior to Randomization.
    6. Patients with uncontrolled hypertension.
    7. Patient has baseline resting oxygen saturation of < 89% on room air
    or use of supplemental oxygen at rest.
    8. Evidence of functional airway stenosis (e.g.,
    bronchomalacia/tracheomalacia, airway stents, or airways requiring
    balloon dilatations to maintain patency) with onset after the initial
    diagnosis of BOS and ongoing at Screening and/or Randomization Visit.
    9. Known hypersensitivity to L-CsA or cyclosporine A.
    10. Patients with chronic renal failure defined as serum creatinine > 2.5
    mg/dL at screening or requiring chronic dialysis.
    11. Patients with liver disease and serum bilirubin > 3-fold upper limit of
    normal range or transaminases > 2.5 upper limit of normal range.
    12. Patients with active malignancy within the previous 2 years,
    including post-transplant lymphoproliferative disorder, with the
    exception of treated, localized basal and squamous cell carcinomas.
    13. Pregnant women or women who are unwilling to use appropriate
    birth control to avoid pregnancy through their End of Study Visit.
    14. Women who are currently breastfeeding.
    15. Receipt of an investigational drug as part of a clinical trial within 4
    weeks prior to the Screening Visit. This is defined as any treatment that
    is implemented under an Investigational New Drug (IND) or
    compassionate use.
    16. Patients who have received extracorporeal photophoresis (ECP) for
    treatment of BOS within 1 month prior to Randomization.
    17. Patients who are currently participating in an interventional clinical
    trial.
    18. Psychiatric disorders or altered mental status precluding
    understanding of the informed consent process and/or completion of the
    necessary procedures.
    19. Any co-existing medical condition that in the Investigator's judgment
    will substantially increase the risk associated with the patient's
    participation in the clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in FEV1 (mL) from baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    E.5.2Secondary end point(s)
    • Mean change in FEV1/FVC from baseline;
    • Time to Progression of BOS, defined as the earliest of the following:
    - Absolute decrease from baseline in FEV1 ≥ 10% or ≥ 200 mL and absolute decrease in FEV1/FVC of > 5%, OR
    - Change in BOS Severity, OR
    - Re-transplantation, OR
    - Death from respiratory failure
    This endpoint will be assessed in a combined analysis with a similar Phase III clinical trial, BT – L-CsA – 301 – SLT (BOSTON-1) which will be conducted in the same investigational centers in patients who have undergone single-lung transplantations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Week 48
    • Time to Progression
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Blinded: pulmonary function technicians, therapists performing spirometry, statisticians
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of Care
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    France
    Germany
    Israel
    Spain
    United Kingdom
    United States
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 110
    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 who complete BOSTON-2 will be eligible to participate in a follow-on study, BT – L-CsA – 303 – FU (BOSTON-3).
    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 Decision2019-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-02
    P. End of Trial
    P.End of Trial StatusOngoing
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