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    Summary
    EudraCT Number:2020-000702-29
    Sponsor's Protocol Code Number:LORALAM-2020
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-000702-29
    A.3Full title of the trial
    Phase-II randomized clinical trial to evaluate the effect of Loratadine associated with Rapamune on Lymphagioleiomyomatosis (LAM).
    Ensayo Clínco randomizado Fase-II para evaluar el efecto de Loratadina asociada a Rapamune en Linfagioleiomiomatosis (LAM).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating the effect of Loratadine associated with Rapamune in Lymphagioleiomyomatosis (LAM).
    Ensayo Clínco para evaluar el efecto de Loratadina asociada a Rapamune en Linfagioleiomiomatosis (LAM).
    A.4.1Sponsor's protocol code numberLORALAM-2020
    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 SponsorIDIBELL (Institut d’Investigació Biomédica de Bellvitge)
    B.1.3.4CountrySpain
    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 supportFondos de Investigación Sanitarioas (FIS)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaria Molina Molina
    B.5.2Functional name of contact pointMaria Molina Molina
    B.5.3 Address:
    B.5.3.1Street AddressCalle Feixa Llarga, s/n
    B.5.3.2Town/ cityL'Hospitalet de Llobregat (Barcelona)
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932606600
    B.5.5Fax number0034932606600
    B.5.6E-mailmariamolinamolina@hotmail.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 Yes
    D.2.1.1.1Trade name Loratadina STADA 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorio STADA S.L
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameLoratadina Stada
    D.3.4Pharmaceutical form Capsule
    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 INNLORATADINE
    D.3.9.1CAS number 79794-75-5
    D.3.9.3Other descriptive nameLORATADINE
    D.3.9.4EV Substance CodeSUB08581MIG
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    EFFECT OF LORATADINE ON LYMPHANGIOLEIOMYOMATOSIS
    EFECTO DE LORATADINA EN LINFANGIOLEIOMIOMATOSIS
    E.1.1.1Medical condition in easily understood language
    EFFECT OF LORATADINE ON LYMPHANGIOLEIOMYOMATOSIS
    EFECTO DE LORATADINA EN LINFANGIOLEIOMIOMATOSIS
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10049459
    E.1.2Term Lymphangioleiomyomatosis
    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
    Evaluate the safety profile of loratadine in combination with rapamycin after 52 weeks
    Assess security (incidence of adverse events according to their
    intensity, severity, relation to treatment) of the combination of loratadine and rapamycin compared with rapamycin in monotherapy in patients with LAM.
    Evaluar el perfil de seguridad de loratadina en combinación con rapamicina tras 52 semanas.
    Evaluar la seguridad (incidencia de acontecimientos adversos según su
    intensidad, gravedad, relación con el tratamiento) de la combinación de loratadina y rapamicina comparada con rapamicina en monoterapia en pacientes con LAM.
    E.2.2Secondary objectives of the trial
    The secondary objectives evaluate:
    a) quality of life and progression free-survival time,
    b) changes in the established LAM serum biomarker VEGFD,
    c) the utility of the major histamine-derived metabolite methylimidazoleacetic acid (MIAA) for monitoring disease progression and biological treatment effect.
    Los objetivos secundarios evalúan:
    a) calidad de vida y tiempo de supervivencia libre de progresión,
    b) cambios en el biomarcador de suero LAM establecido VEGFD,
    c) la utilidad del principal metabolito ácido metilimidazolacético (MIAA) derivado de la histamina para controlar la progresión de la enfermedad y el efecto del tratamiento biológico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with LAM and > 18 years-old with:
    - FEV1 > 35% and DLCO > 20%
    - Oxygen saturation (SpO2) > 85% by pulse oximetry while breathing ambient air at rest.
    - Patients with a definite diagnosis consistent with LAM prior to screening based on International consensus criteria within 10 years prior to randomization.
    - HRCT within 12 months prior to randomization with central reading demonstrating a radiological pattern suggesting LAM and some other criteria for initiating sirolimus (symptoms, FEV1 decline or the presence of abdominal lynphangioleiomiomas).
    - Taking stable doses of rapamycin for at least the last 3 months.
    Pacientes afectas de LAM, mayores de 18 años, que presenten:
    - Diagnóstico definitivo de LAM basado en el consenso internacional y
    guías clínicas, máximo 10 años antes de la randomización. El
    diagnóstico deberá ser de certeza (tras evaluación por Comité
    Multidisciplinar de Intersticio de cada centro participante).
    - FEV1 > 35% y DLCO > 20%
    - Saturación de oxígeno (SatO2) > 85% en reposo y sin oxígeno
    suplementario
    - TAC de torax 12 meses antes de la randomización sugestivo de LAM
    - Toma de dosis estables de rapamicina como mínimo en los últimos 3
    meses
    E.4Principal exclusion criteria
    - Concomitant use of other HR1 antagonist.
    - Hypersensitivity to HR1 antagonists.
    - Current smoker or ex-smoker having quit smoking < 4 months prior to firs screening visit.
    - Use of systemic immunosuppressants or chemotherapy within 30 days of screening.
    - Receiving oral corticosteroids>15mg/day, vasodilator therapies for pulmonary hypertension (e.g., bosentan), unapproved and/or investigational therapies for LAM or administration of such therapies within 4 weeks of initial screening.
    - At baseline/screening visit, values of liver transaminases above 3 times upper limit, alkaline phosphatase above 2.5 times upper limit, or bilirubin above 1.5 times upper limit.
    - Creatinine clearance (CrCl)<60ml/min (determined by Cockcroft-Gault Equation) at baseline/screening visit.
    - Patients treated with strong inhibitors and inducers of CYP either during the study or 14 days prior to enrolment in the study: antifungals (e.g., ketoconazole, itraconazole), clarithromycin, telithromycin, cobicistat, protease inhibitors (e.g., atazanavir, ritonavir, and saquinavir) and grapefruit juice, phenytoin, carbamazepine, barbiturates, rifampin.
    - Current allergic asthma or other major allergic diseases that requires different daily antihistaminic treatment.
    - History of coexistent and clinically significant (in the opinion of the Investigator) chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, inadequately treated sleepdisordered
    breathing, or any clinically significant pulmonary diseases other than LAM.
    - Uso concomitante habitual (mínimo 3 días/semana) de cualquier
    antagonista de la histamina (incluido además de loratadina, ebastina, y
    similares).
    - Hipersensibilidad a los antagonistas de la histamina o anti-histamínicos, especialmente del receptor HR1.
    - Embarazo.
    - Lactancia y voluntad de procreación en el año siguiente a la inclusión.
    - Tratamiento contraceptivo inadecuado.
    - Tabaquismo activo (en momento estudio o toma de último cigarro hace menos de 3 meses).
    - Uso de inmunosupresores o inmunomoduladores sistémicos o
    quimioterapia dentro de los 30 días del screening.
    - Toma corticoides orales a dosis > 15 mg/día, terapias vasodilatadoras para la hipertensión arterial pulmonar (ejemplo; bosentan), fármacos no aprobados o en investigación para LAM en el periodo de 4 semanas antes de la visita de screening.
    - Insuficiencia hepática grave.
    - Insuficiencia renal: Clearance de creatinina (CrCl) < 60 ml/min
    - Pacientes que reciban como tratamiento algún potente inhibidor o inductorde la enzima hepática CYP durante el screening o 14 días previos a la randomización: antifúngicos (ej. Ketoconazol, itraconazol), claritromicina, telitromicina, cobicistato, fenitoina, carbamacepina, barbitúricos, rifampicina, inhibidores de proteasas como atazanavir, ritonavir y saquinavir, o bien toma de pomelo.
    - Asma alérgica u otro trastorno alérgico mayor que requiera la toma diaria o habitual de anti-histamínicos.
    - Otra enfermedad pulmonar grave coexistente (en opinión del investigador) como enfisema severo, bronquiectasieas, asma, SAHS severo no controlado.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of adverse effects associated with taking loratadine associated with rapamycin, including nausea, diarrhea, abdominal pain, vomiting, headache, hypertransaminasemia.
    Incidencia de efectos adversos asociados a la toma de loratadina asociada a rapamicina, incluyendo nausea, diarrea, dolor abdominal, vómito, cefalea, hipertransaminasemia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The assessment of the primary point is at 52 weeks
    La valoración de la variable primaria es a las 52 semanas
    E.5.2Secondary end point(s)
    -Progression-free survival time, which will be considered when some of these events are present: FEV1 decrease > 10%, DLCO decrease > 15%, lung transplant, death.
    -Hospitalization. Registration of any cause of hospitalization
    - Mantenimiento de la estabilidad clínica (caída FEV1 < 10% o de la DLCO < 15%).
    - Decrease in the number of hospitalizations for any cause and respiratory cause.
    - Lung transplant.
    - Death.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The assessment of the primary point is at 52 weeks
    La valoración de la variable primaria es a las 52 semanas
    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 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 concerned5
    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
    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 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) Yes
    F.1.2.1Number of subjects for this age range: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state62
    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 patient's participation in the project will end at the end of the last scheduled visit
    La participación del paciente en el proyecto finalizará al acabar la última visita prevista
    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 Decision2021-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-02
    P. End of Trial
    P.End of Trial StatusOngoing
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