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    Summary
    EudraCT Number:2019-001160-29
    Sponsor's Protocol Code Number:NAL-II-19-1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-001160-29
    A.3Full title of the trial
    A single blind, placebo controlled, three period, chronic dosing (6 weeks), multicentre, exploratory study to evaluate the effects of Nacystelyn (20 mg BID and 40 mg BID) on Functional Respiratory Imaging (FRI) parameters in subjects with moderate to severe COPD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to evaluate the effects of nacystelyn in COPD patients by using Functional respiratory Imaging.
    A.4.1Sponsor's protocol code numberNAL-II-19-1
    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 SponsorLABORATOIRES SMB S.A
    B.1.3.4CountryBelgium
    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 supportLABORATOIRES SMB S.A
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLABORATOIRES SMB S.A
    B.5.2Functional name of contact pointCLINICAL DEPARTMENT
    B.5.3 Address:
    B.5.3.1Street Address26-28 rue de la Pastorale
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1080
    B.5.3.4CountryBelgium
    B.5.4Telephone number322411 48 28
    B.5.5Fax number32 2 411 28 28
    B.5.6E-maildptclinique@smb.be
    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 nameNacystelyn 20 mg
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 INNL-Lysine-N-acetyl-cysteinate
    D.3.9.1CAS number 89344-48-9
    D.3.9.2Current sponsor codeNAL
    D.3.9.3Other descriptive nameNACYSTELYN
    D.3.9.4EV Substance CodeSUB192517
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    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 placeboInhalation powder, hard capsule
    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
    E.1.1.1Medical condition in easily understood language
    COPD includes chronic bronchitis and emphysema (= less elastic lungs, shortness of breath may occur) and is characterized by airway narrowing that is not fully reversible.
    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 20.0
    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 objective of this study is to assess the effect of chronic dosing of different doses of NAL on changes in airway geometry with Functional Respiratory Imaging (FRI).
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to assess the effect of chronic dosing of different doses of NAL on changes in lung function parameters and patient reported outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient is able to give signed written informed consent prior to study entry.
    2.Male or female patients 40 – 85 years, inclusive, as of the screening visit.
    3.Patient is an ex-smoker with a minimum 10 pack-years of historical use (the equivalent of one pack per day for 10 years).
    4.Patient has a diagnosis of COPD according to the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria with a postbronchodilator FEV1 of 25 - 60% of predicted and a FEV1/FVC<0.7.
    5.Patients has the ability to perform acceptable and repeatable spirometry according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005 criteria and/or protocol-defined criteria.
    6.Patient is able to withhold rescue medication for at least 6 hours prior to the study visits.
    7.Patient is free of any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
    8.Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.
    9. Patient must be able to use the study inhaler device (Axahaler®).
    10.If female, is currently not pregnant, not breast feeding, has a negative urine pregnancy test and is of
    •nonchildbearing potential, defined as:
    - 1 year post-menopausal
    - surgically sterile (tubal ligation, oophorectomy, or hysterectomy)
    - diagnosed as infertile and not undergoing treatment to reverse infertility
    or is of
    •childbearing potential, has a negative urine pregnancy test at the screening visit and willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study:
    - systemic contraception used for 1 month prior to screening, including birth control pills, transdermal patch (EVRA® or equivalent), vaginal ring (NUVARING® or equivalent), levonorgestrel implant (NORPLANT® or equivalent), or injectable progesterone (DEPO-PROVERA® or equivalent)
    - double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide)
    - intra-uterine device with a low failure rate <1% per year
    - monogamous with a vasectomized male partner or exclusively has same-sex partners.
    E.4Principal exclusion criteria
    1.Known respiratory disorder other than COPD, including but not limited to the following: alpha-1-antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary oedema, or interstitial lung disease, known active tuberculosis.
    2.Evidence or history of other clinically significant disease or abnormality that in the opinion of the Investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
    3.Hospitalization for a COPD exacerbation or pneumonia within 6 weeks prior to the screening visit.
    4.Treatment for a non-hospitalized COPD exacerbation or pneumonia requiring antibiotics and/or systemic corticosteroids within 4 weeks prior to the screening visit.
    5.The patient is pregnant or lactating, or plans to become pregnant or donate gametes (ova or sperm) during the study period or for 30 days after the patient’s last study-related visit (for eligible patients only, if applicable). Eligible female and male patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. Any patient becoming pregnant during the study will be withdrawn from the study.
    6.Treatment with oral, intravenous, or intramuscular corticosteroids within 4 weeks prior to the screening visit.
    7.Inability to discontinue prohibited medications during the screening, run-in and treatment periods.
    8.Documented or suspected viral or bacterial, upper respiratory infection (URI) or lower respiratory infection (LRI), sinusitis, sinus infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or illness within 4 weeks prior to the screening visit.
    9.Patient did experience an AE that, in the opinion of the Investigator, would result in failure to meet the inclusion/exclusion criteria during the screening period.
    10.History of allergy or hypersensitivity to acetylcysteine, anticholinergic/ muscarinic receptor antagonist agent, beta-2 agonists, mannitol, or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
    11.Factors (e.g. infirmity, disability, or geographic location) that the Investigator feels would likely limit the patient's compliance with the study protocol or study visits.
    12.Current evidence or known history of alcohol or substance abuse within 2 years of the screening visit.
    13.Patient is either an employee of the investigational center or an immediate relative of an employee of the investigational center.
    14.History of lung volume reduction surgery within the previous 12 months prior to the screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    The following primary FRI endpoints will be evaluated:
    Structure:
    •specific airway volume (siVaw) at FRC (V1 and V4) & TLC
    Function:
    •specific airway resistance (siRaw) at FRC (V1 and V4) and TLC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visits 1 & 4
    E.5.2Secondary end point(s)
    The secondary FRI endpoints are:
    Exposure:
    •aerosol deposition
    Structure:
    •lung and lobar volume at FRC (V1 and V4) & TLC
    •airway wall volume
    Function:
    •internal airflow distribution

    The secondary spirometry endpoints are:
    •Forced expiratory volume in 1 second (FEV1)
    •Functional residual capacity (FRC)
    •Forced vital capacity (FVC)
    •Tiffeneau-Pinelli index (FEV1/FVC ratio)

    Additional secondary endpoints are :
    •Vital Capacity (VC) and Total Lung Capacity (TLC), based on body plethysmography
    •Airway resistances: Airway resistance (Raw) and Specific airway conductance (SGaw), based on body plethysmography
    •Patient reported outcomes: CRQ-SR
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visits 1 to 4
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 trial3
    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 concerned4
    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 months8
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state24
    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 Decision2019-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-20
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