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    Summary
    EudraCT Number:2016-001805-18
    Sponsor's Protocol Code Number:Emera003
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-19
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-001805-18
    A.3Full title of the trial
    A randomised, placebo-controlled, blinded, cross-over, pilot study to explore safety and efficacy of NBMI treatment of patients with mild, moderate and severe Chronic Obstructive Pulmonary Disease (COPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot study to explore safety and efficacy of NBMI treatment compared to placebo in patients with Chronic Obstructive Pulmonary Disease (COPD)
    A.4.1Sponsor's protocol code numberEmera003
    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 SponsorNBMI Science AB
    B.1.3.4CountrySweden
    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 supportNBMI Science AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNBMI Science AB
    B.5.2Functional name of contact pointCEO
    B.5.3 Address:
    B.5.3.1Street AddressFogdevreten 2
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code171 65
    B.5.3.4CountrySweden
    B.5.6E-mailragnar.klingberg@emeramed.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 nameEmeramide
    D.3.2Product code NBMI
    D.3.4Pharmaceutical form Capsule, hard
    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 INNEmeramide
    D.3.9.2Current sponsor codeN1, N3-bis(2-mercaptoethyl)isophthalamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboCapsule, hard
    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
    Patients with Chronic Obstructive Pulmonary Disease (COPD).
    E.1.1.1Medical condition in easily understood language
    In COPD damage to the lungs leads to decreased lung function, an overwhelming number of patients are smokers or former smokers. Symptoms include dyspnoea, cough and increased sputum production.
    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 19.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    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 objectives for this study is to evaluate the safety and tolerability of NBMI in patients with mild, moderate and severe COPD.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    - To evaluate the efficacy of NBMI daily oral administration for 14 days on cough in patients with mild, moderate and severe COPD.
    - To evaluate the efficacy of NBMI daily oral administration for 14 days on COPD health status and individual symptoms in patients with mild, moderate and severe COPD.
    - To evaluate the efficacy of NBMI daily oral administration for 14 days on lung function in patients with mild, moderate and severe COPD.


    The exploratory objectives are:
    - To investigate the pharmacokinetics of NBMI in patients with mild, moderate and severe COPD.
    - To explore the effect of NBMI on a panel of inflammatory and oxidative stress biomarkers in patients with mild, moderate and severe COPD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects, age between 45 and 75 years, including
    2. Ex-smokers, who quit smoking > 6 months prior to screening visit, with a smoking history of at least 10 pack years
    3. Diagnosis of COPD according to GOLD stages I-III, i.e.
    Post-beta-2-agonist FEV1/FVC < 0.70 and
    Post-beta-2-agonist FEV1 > 30 % of predicted value
    4. Active symptomatic COPD with a total COPD assessment test (CAT) score >10
    5. Bronchitis with cough and sputum production during many days of the last month, and at least three months during the last year
    6. Has signed informed consent for participation
    7. Willingness and ability to comply with study procedures, visit schedules, and other instructions regarding the study.
    E.4Principal exclusion criteria
    1. Patient with more than 2 COPD exacerbation requiring treatment with systemic corticosteriods and/or antibiotics or hospitalization within the last year
    2. Patient with COPD exacerbation requiring treatment with systemic corticosteroids and/or antibiotics or hospitalization within the last 4 weeks
    3. New medication or change of dose for COPD treatment within 4 weeks prior to randomisation (chronic treatment with stable dose is allowed)
    4. Ongoing treatment with systemic steroids, antibiotics, oxygen treatment, N-acetylcysteine (NAC) or roflumilast within 4 weeks of randomisation
    5. Clinically significant heart failure, heart infarction, stroke or TIA within 12 months of study screening
    6. Ongoing treatment with warfarin at screening visit
    7. History of alcohol abuse or substance/drug abuse within 12 months prior to screening visit
    8. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
    9. Any clinically significant abnormalities in clinical chemistry or haematology results at the time of screening, as judged by the investigator
    10. History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the investigator, including history of hypersensitivity to drugs with a similar chemical structure or class to NBMI
    11. History of allergy/hypersensitivity to bisulphites (e.g. red/white wine)
    12. Positive pregnancy test in women at screening visit
    13. Serious bacterial or chronic viral infection such as human immunodeficiency virus (HIV) or hepatitis virus at screening visit
    14. Participation in any other clinical study that included drug treatment within three months prior randomisation
    15. Investigator considers subject unlikely to comply with study procedures, restrictions and requirements.
    E.5 End points
    E.5.1Primary end point(s)
    - Adverse events in terms of frequency and severity compared to placebo treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    NBMI treatment period compared to placebo period
    E.5.2Secondary end point(s)
    - Changes from baseline in Leicester cough questionnaire compared to placebo treatment
    - Changes from baseline in pre- and post-bronchodilator FEV1 and FVC compared to placebo treatment
    - Changes from baseline in COPD assessment (CAT) test compared to placebo treatment
    - Changes from baseline in St George´s respiratory questionnaire compared to placebo treatment
    - Changes from baseline in modified Medical Research Council (mMRC) dyspnoea scale compared to placebo treatment
    - Changes from baseline in 6 Minute walk test measurements compared to placebo treatment
    - Changes from baseline in Multidimensional Dyspnoea Profile (MDP) compared to placebo treatment

    - Changes from baseline of standard haematology and clinical chemistry laboratory analyses (e.g. blood, kidney, liver, infections) compared to placebo treatment
    - Changes from baseline of vital signs (incl. oxygen saturation (spO2), blood pressure, pulse, body weight) compared to placebo treatment

    Exploratory endpoints:
    - Pharmacokinetic parameters derived from plasma concentrations of NBMI
    - Changes from baseline in oxidative stress-related biomarkers in plasma compared to placebo treatment
    - Changes from baseline in inflammatory biomarkers in plasma compared to placebo treatment
    - Changes from baseline in daily physical activity compared to placebo treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 days treatment compared to baseline
    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.8.2.4Number 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 concerned2
    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
    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 months12
    E.8.9.1In the Member State concerned days
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state12
    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)
    The study is designed as an add-on of investional product to the patients' standard medications. After study end, the patients will continue with their standard medications, or as decided by their physician.
    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 Decision2016-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-16
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