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    Summary
    EudraCT Number:2021-005578-24
    Sponsor's Protocol Code Number:OPT-OMA-ASTHMA
    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:2022-02-02
    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 number2021-005578-24
    A.3Full title of the trial
    Therapheutic optimization of omalizumab in allergic severe asthma patients by dose and frequency of administration adjustment
    Optimización terapéutica de omalizumab en pacientes con asma alérgica grave no controlada ajustando dosis y frecuencia de administración
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Omalizumab’s dose reduction or increase in the frequency of administration in patients who suffer from allergic severe asthma.
    Reducción de dosis o aumento de la frecuencia de administración del omalizumab en pacientes con asma alérgica grave no controlada
    A.4.1Sponsor's protocol code numberOPT-OMA-ASTHMA
    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 SponsorConsorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
    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 supportConsorci Mar Parc de Salut de Barcelona
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConsorci Mar Parc de Salut de Barcelona
    B.5.2Functional name of contact pointHospital del Mar
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Marítim
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932485074
    B.5.6E-mail62915@psmar.cat
    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 Xolair solución inyectable en jeringa precargada.
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOmalizumab
    D.3.9.1CAS number 242138-07-4
    D.3.9.4EV Substance CodeSUB12543MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E.1.1.1Medical condition in easily understood language
    Patients with controlled allergic asthma and under omalizumab treatment for one year.
    Pacientes con asma alergica controlada y en tratamiento durante un año con omalizumab.
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    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 aim of this study is to value if a 50% omalizumab dose reduction in patients who suffer from allergic asthma, will allow to keep the same control of clinical stability. It is assessed by the lack of crisis, quality life and lung function.
    El objetivo del estudio es valorar si una reducción de dosis de omalizumab del 50% en pacientes con asma alérgico grave permitiría mantener el mismo control de estabilidad clínica medido por ausencia de crisis, calidad de vida y función pulmonar.
    E.2.2Secondary objectives of the trial
    - To make a cost minimization analysis of intervention: last vs next year.
    - To determine a correlation between probable prognostic factors with a good response to the dose reduction
    Los objetivos secundarios son:
    - Realizar un análisis coste-efectividad de la intervención: año anterior vs año posterior.
    - Determinar correlación entre posibles factores pronósticos con respuesta a la reducción de dosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients: 18 - 80 years.

    Before 6-month, the patient must have kept the follow inclusion criteria:
    - Omalizumab adherence: 100%.
    - ACT ≥19.
    - Stable FEV1 (>80%) or the best value of those patients that don’t reach the 80% due to previous deterioration lung function.
    - Don’t make use of oral corticosteroids.
    - Lack of emergency visits or hospital admissions.

    Patients shall go or shall answer to in-person or telephonic visits.

    Patients must understand, accept, and sign the informed consent. A legal tutor can also give the authorisation to participate in the study.
    Pacientes entre 18 - 80 años.

    Ha de cumplir que en el período de 6 meses anterior a la fecha de inclusión cumpla:
    - Adherencia al omalizumab.
    - ACT ≥19.
    - FEV1 estable (>80%) o el mejor valor en aquellos pacientes que no alcancen el 80% por el deterioro previo del paciente.
    - No uso de corticoides orales.
    - Ausencia de visitas a urgencias/ingresos hospitalarios.
    Se ha de comprometer a acudir o responder a las visitas presenciales o telefónicas programadas.

    Entiendan, acepten el estudio y firmen el consentimiento informado. O en aquellos que el representante legal dé la autorización para participar en el estudio.
    E.4Principal exclusion criteria
    Those patients who do not keep the inclusion criteria (see inclusion criteria).

    Excluded patients: omalizumab for the treatment of other diseases, use of immunosuppressors or oral corticosteroids and those who have a diagnostic of other chronic respiratory diseases (such as cystic fibrosis, COPD, cancer, or immunodeficiency disease).

    Don't consent of legal tutor.
    Aquellos que incumplan alguno de los puntos anteriormente mencionados en el apartado de criterios de inclusión.

    Pacientes en tratamiento con omalizumab por otras patologías, en tratamiento concomitante con inmunosupresores o corticoides orales, diagnosticados de otras enfermedades respiratorias crónicas (fibrosis quística, EPOC, cáncer o inmunodeficiencias).
    E.5 End points
    E.5.1Primary end point(s)
    Exacerbation. It is defined as a decline of basal clinical state of patient. As a result, the patient should take specific drugs to resolve the situation.

    It is evaluated by dyspnoea, sibilant breath, the increase of respiratory frequency, the need of systemic corticosteroids, decline of FEV1, emergency visits and/or hospital admission. If one of these situations are developed, the intervention will be considered a negative result. Each exacerbation will always verify that is a direct cause of reduction doses, discarding others potential factors.
    Es la presencia de exacerbación durante el periodo del estudio, definida como episodio de deterioro de la situación clínica basal del paciente que implica la necesidad de administrar tratamiento específico. Se medirá registrando: presencia de crisis asmática, necesidad de uso de corticoides sistémicos, deterioro del FEV1 habitual del paciente, visitas a urgencias y/u hospitalización. La presencia o la alteración paramétrica de algunos de estos valores se traducirá como resultado negativo de la intervención. Siempre se comprobará que este resultado es causa directa de la reducción de dosis, descartando otros posibles factores.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the first intervention, exacerbation will be evaluated each 4 weeks to the week 48 by telephonic call and a day hospital visit, alternately. After that, exacerbation will be evaluated each 4 months in the follow-up period.
    Se medirá desde la primera modificación de dosis cada 4 semanas hasta completar 48 semanas. Para llevar al cabo el registro se irán alternando visitas presenciales y llamadas telefónicas durante dicho tiempo. Y después se harán cada 4 meses durante el periodo de seguimiento.
    E.5.2Secondary end point(s)
    Other secondary endpoints included: baseline demographic and clinical data, ACT total score, change from baseline in FEV1, blood eosinophil and lymphocytes count and the need of inhaled or systemic corticosteroids and rescue medication. Others as: FeNO, IgE, FcREI of basophils and omalizumab plasmatic concentration. Economical cost of drug dispensation will be collected by registering dispensations, hospital admissions, emergency visit and requeriment of injectable corticosteroids.
    Otras variables secundarias serán: variables demográficas y clínicas, el resultado del Asthma Control Test (ACT), el FEV1 del paciente, la necesidad de medicación de rescate, el hemograma, el uso de corticoides inhalados u orales. Otras variables de medida observacional serán: FeNO, IgE, el nivel de densidad del receptor FcREI de los basófilos y la concentración plasmática del omalizumab El coste económico del omalizumab se valorará según los costes en dispensaciones, visitas a urgencias, ingresos y medicación hospitalarios (corticoides inyectables).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Baseline demographic and clinical data will be only measured in the inclusion visit.
    - ACT, FEV, the need of inhaled or systemic corticosteroids and rescue medication will be valued every 4 weeks.
    - Blood eosinophil and lymphocytes count and FeNO will be measured in every presential visit.
    - FcREI of basophils and IgE count will be determined in inclusion, basal and final visit and week 4, 24,28 and 48.
    - Plasmatic concentration will be collected in basal and final visit and week 24 and 48.
    - The cost of omalizumab will be calculated at the end of the study.
    - Datos demográficos y clínicos serán registrados solo en la visita basal.
    - El ACT, el FEV1, el uso de medicación de rescate, de corticoides inhalados u orales será valorado cada 4 semanas.
    - Eosinofilia y linfocitos y la prueba del FeNO será medico en cada visita presencial.
    - El valor de IgE y el del receptor FcREI de los basófilos será determinado en la visita de inclusión, basal y final y en las semanas 4, 28 y 48.
    - La concentración plasmática será recogida en la visita basal y final y en las semanas 24 y 48.
    - El coste del omalizumab se calculará al final del estudio.
    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 No
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Estudio de un solo brazo
    Single arm study
    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.8.2.4Number of treatment arms in the trial1
    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
    The trial will stop before the last visit if more than 15% of patients develop an exacerbation. It will be considered that there are more risks than benefits. It was estimated by searching the total registered exacerbations in two asthma real-life studies.
    Other criteria are :development of adverse events not including in data sheet or not-compliance of study’s rule
    El estudio se parará antes de la última visita, en el caso de que se supere un 15% de pacientes que presenten crisis o exacerbación, el estudio finalizará, por demostrar un mayor riesgo que beneficio de la intervención. Se determina este porcentaje en base a los estudios en vida real que se han llevado a cabo (Pelai et al y Schreiber J et al.)
    Otros criterios serán: la aparición de acontecimientos adversos no esperados a los de la ficha técnica o el incumplimiento de las reglas del estudio.
    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 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: 45
    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 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 state55
    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
    Ninguno
    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 Decision2022-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-02
    P. End of Trial
    P.End of Trial StatusOngoing
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