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    Summary
    EudraCT Number:2022-001611-50
    Sponsor's Protocol Code Number:S67072
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-10-14
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2022-001611-50
    A.3Full title of the trial
    Patient reported efficacy of intranasal lysine-aspirin in controlling NSAID-exacerbated respiratory disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The efficacy of nasal lysine aspirin in controlling NSAID-worsening respiratory disease, from the patient's point of view.
    A.4.1Sponsor's protocol code numberS67072
    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 SponsorUZ Leuven
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Research Foundation - Flanders (FWO)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Leuven
    B.5.2Functional name of contact pointOtorhinolaryngology, head and neck
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.6E-mailnkogh_info@uzleuven.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 Yes
    D.2.1.1.1Trade name Aspegic 500 mg - powder for oral solution
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Belgium
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Powder for oral solution in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INND,L-Lysine Acetylsalicylate
    D.3.9.1CAS number 62952-06-1
    D.3.9.3Other descriptive nameLysine aspirin
    D.3.9.4EV Substance CodeSUB34053
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number900
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Mini-Plasco NaCl B.Braun - Solution for injection - 0,9%
    D.2.1.1.2Name of the Marketing Authorisation holderB.Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM CHLORIDE
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(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
    Aspirin-Exacerbated Respiratory Disease (AERD) in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
    E.1.1.1Medical condition in easily understood language
    Patients with chronic rhinosinusitis with nasal polyps, suffering from Aspirin Induced Asthma (AIA)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 25.1
    E.1.2Level LLT
    E.1.2Classification code 10075084
    E.1.2Term Aspirin-exacerbated respiratory disease
    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
    (1) Effect of nasal ATAD with lysine-aspirin on patient reported outcomes:
    - Rhinosinusitis and Asthma severity Visual analogue scale (VAS)
    - Nasal Congestion/Obstruction (NC) score
    - Short version of the Olfactory Disorders-Negative Statements (sQODNS)
    - Asthma control, measured with the Asthma Control Questionnaire (ACQ-6);
    - Health-related quality of life, using disease-specific health-related quality of life score, such as the Sino-Nasal Outcome Test-22 (SNOT-22) and the Standardised Asthma Quality of Life Questionnaire (AQLQ (S));
    - Patient recognition of improvement: Patient Global Impression of Change (PGIC).
    - EQ-5D-5L to describe and value health
    (2)Incidence of significant serious and non-serious adverse events related to gastro-intestinal disturbance (nausea, vomiting, diarrhoea, abdominal pain).
    (3) Effect of nasal ATAD on provoking dose during nasal lysine-aspirin provocation test
    E.2.2Secondary objectives of the trial
    (1) Effect of nasal lysine-aspirin on upper and lower airway:
    - Peak Nasal Inspiratory Flow (PNIF),
    - Smell score (UPSIT),
    - Forced Expiratory Volume in 1 second (FEV1),
    - Bronchial and nasal inflammation (Fractional exhaled NO (FeNO) and nasal NO (nNO).
    (2) Effect of nasal lysine-aspirin on polyp growth:
    - Nasal Polyp Score (NPS),
    - The ability in reducing the proportion of patients who require surgery for nasal poyps (NP)
    (3) Effect of nasal lysine-aspirin on corticosteroid use:
    - The ability in reducing the proportion of patients who require treatment with oral corticosteroids (OCS) for relief of chronic rhinosinusitis and asthma exacerbations.
    - Changes in dosage of inhaled/intranasal corticosteroids)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient has N-ERD: intolerance to aspirin is confirmed by a nasal lysine-aspirin provocation test in the pre-trial S65796 (EUDRACT: 2022-000215-31)
    - Patients older than 18 years.
    E.4Principal exclusion criteria
    - Female who is pregnant or breast-feeding.
    - Participants with severe gastro-intestinal disease or with bleeding diathesis.
    - Participants with chronic urticaria.
    - Participants with unstable cardiovascular conditions/cardiopulmonary disease where epinephrine is contraindicated.
    - Participants with severe chronic obstructive pulmonary disease (COPD).
    - Participants with poorly controlled asthma, defined as:
    a. FEV1 < 65 % predicted while on preventative inhalers
    b. Participants who experienced an asthma exacerbation requiring hospitalization (>24 hours) for treatment of asthma within 3 months before screening
    - Participants who have undergone any intranasal and/or sinus surgery (including polypectomy) within 2 months before screening.
    - Participants with major anatomical nasal abnormalities or conditions/concomitant diseases being responsible for nasal obstruction and making them nonevaluable at screening, but not limited to: antrochoanal polyps, nasal septal deviation that would occlude at least one nostril, acute sinusitis, nasal infection or upper respiratory infection requiring treament with systemic antibiotics, antivirals or antifungals, ongoing rhinitis medicamentosa, fungal rhinosinusitis.
    - Participants who have taken biologic therapy within 3 months prior to screening or 5 half-lives, whichever is longer
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline in VAS for rhinosinusitis and asthma severity
    - Change from baseline in NC score
    - Change from baseline in ACQ-6 score
    - Change from baseline in SNOT-22 score
    - Change from baseline in AQLQ(S)
    - Change from baseline in PGIC
    - Change from baseline in sQODNS score
    - Change from baseline in EQ-5D-5L
    - Change from baseline in provoking dose
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trial
    E.5.2Secondary end point(s)
    - Change from baseline in PNIF
    - Change from baseline in smell score (UPSIT)
    - Change from baseline in FEV1
    - Change from baseline in FeNO and nNO
    - Change from baseline in NPS
    - Proportion of patients who have or are planned for surgery of nasal polyps, as well as time-to-event
    - Proportion of patients with OCS use for chronic rhinosinusitis/asthma exacerbation, as well as time to first course, number of courses, total dose used, total duration.
    - Dosage (dose and frequency) of inhaled/intranasal corticosteroids, reported as dosage during desensitisation and dosage during maintenance therapy (after goal of escalation is reached).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the trial
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    E.8.2.3Other No
    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 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 years2
    E.8.9.1In the Member State concerned months
    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) No
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state30
    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 Decision2022-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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