E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic Rhinoconjunctivitis and Chronic Urticaria |
Rinoconjuntivitis alérgica y urticaria crónica |
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E.1.1.1 | Medical condition in easily understood language |
Allergic Rhinoconjunctivitis and Chronic Urticaria |
Rinoconjuntivitis alérgica y urticaria crónica |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The study objectives will be to evaluate the safety and tolerability of 10 mg once daily bilastine in children from 2 to 11 years of age with either allergic rhinoconjunctivitis or chronic urticaria. The primary objective will be the evaluation of the safety (TEAEs, Treatment Emergent Adverse Events). |
Los objetivos del estudio serán evaluar la seguridad y la tolerabilidad de 10 mg de Bilastine administrada una vez al día en niños de 2 a 11 años con rinoconjuntivitis alérgica o urticaria crónica. El objetivo principal será la evaluación de la seguridad (AAEs, Acontecimientos Adversos Emergentes). |
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E.2.2 | Secondary objectives of the trial |
The assessment of: -safety and tolerability of bilastine in terms of physical examination, vital signs, ECG, blood tests, somnolence/sedation. -quality of life. |
La evaluación de: -La seguridad y tolerabilidad de Bilastina en términos de exploración física, signos vitales, ECG, análisis de sangre, somnolencia/sedación. -Calidad de vida |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(1) Boys and girls between 2 and 11 years old, inclusive, at screening. (2) Documented history of allergic rhinoconjunctivitis (AR) or chronic urticaria (CU) with clinical symptoms at study entry. (3) For AR patients, a positive skin prick test/RAST for at least one allergen. (4) A 12 lead ECG obtained at screening within acceptable limits, moreover in absence of any drug effect or disease, QTc interval values (msec) after Fridericia's correction must be normal (not prolonged). The values considered to be normal are lower than 440 msec. (5) Children who have written consent from their parent(s)/guardian to participate in the study. Children should be informed according to their understanding (assent form will be obtained whenever possible). |
(1) Niños y niñas entre 2 y 11 años, inclusive, en el momento de la inclusión. (2) Historia documentada de rinoconjuntivitis alérgica (RA) o urticaria crónica (UC) con síntomas clínicos a la entrada del estudio. (3) Para pacientes con RA, deberán realizar una prueba de reacción cutánea/RAST positiva al menos a un alérgeno. (4) Se obtendrá un ECG de 12 derivaciones en la visita de selección que esté dentro de los límites aceptables, además de ausencia de efectos de medicamentos o enfermedades, los valores del intervalo QTc (mseg) después de la corrección de Fridericia deben ser normales (no prolongados). Se considerarán valores normales los que estén < 440 mseg. (5) Niños que hayan consentido por escrito por parte de sus padres/tutores a participar en el estudio. Los niños deben ser informados del estudio de acuerdo a sus capacidades (siempre que sea posible se obtendrá el formulario de conformidad). |
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E.4 | Principal exclusion criteria |
(1) Non-allergic rhinitis or acute urticaria. (2) Intake of particular medications with antiallergenic activities or sedative properties. (3) Known allergy/hypersensitivity to the study drug (bilastine) or its inactive ingredients. (4) Patients who are taking or have taken any of the following medications prior to randomisation in the study and have not complied with the specified washout period of 7 days unless otherwise noted: - Oral corticosteroids. - Antihistamines: Loratadine/ desloratadine (10 days) other systemic antihistamines (3 days). - Anti-leukotrienes. - Delayed-release corticosteroids (3 months). - Ketotifen (2 weeks). - Macrolides antibiotics and imidazolic antifungals (systemic). - Anticholinergics. - Investigational medication or antibodies. - Regular schedule immunotherapy can be maintained throughout the study but will be disallowed from 24h prior to 24h after first study dosing. (5) Clinically relevant abnormal laboratory values indicative of physical illness (including clinically significant ECG abnormalities as judged by the investigator; e.g. Wolff-Parkinson-White syndrome or long QT syndrome), or patient whose health could be harmed by their participation in the study at investigator criteria. (6) Hypersensitivity to H1 antihistamines or benzimidazoles. (7) Any clinical conditions or relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, haematological, endocrine or neurological diseases that in the opinion of the investigator would make the subject unsuitable for the study or interfere with the aim of the study. (8) Children or parent(s) unable to comply with the study requirements (attendance to visits), unable to take the study treatment, or children that should have to travel to another geographic area during the course of the study. (9) Girl who is pregnant or lactating. (10) Children who have a recent history (within previous 12 months) of drug addiction or alcohol abuse. (11) Participation in another clinical study within 30 days prior to the first study drug intake. |
(1) Rinitis no alérgica o urticaria aguda. (2) Ingesta de medicamentos con componentes antialergénicos o propiedades sedativas. (3) Alergia conocida/hipersensibilidad a la medicación del estudio (Bilastina) o a sus ingredientes inactivos. (4) Pacientes que estén tomando o hayan tomado cualquiera de las siguientes medicaciones antes de su aleatorización en el estudio y que no hayan cumplido con el periodo específico de lavado de 7 días, a no ser que se exprese lo contrario: Corticosteroides orales - Antihistamínicos: Loratadina / desloratadina (10 días), otros antihistamínicos sistémicos (3 días) - Antileucotrienos. - Corticosteroides de acción retardada (3 meses) - Ketotifen (2 semanas) - Antibióticos macrólidos y fungicidas imidiazólicos (sistémicos) - Anticolinérgicos - Medicación en investigación o anticuerpos - Se mantendrá la inmunoterapia programada de manera regular durante el estudio pero no estará permitida desde las 24 horas previas hasta las 24 horas posteriores después de la primera dosis de la medicación del estudio. (5) Parámetros anormales de laboratorio de relevancia clínica que indiquen enfermedad física (incluyendo anormalidades clínicamente significativas en el ECG a criterio del investigador; p. ej. Síndrome de Wolff-Parkinson-White o síndrome QT prolongado), o pacientes cuya salud pueda verse dañada, a criterio del investigador, por su participación en el estudio. (6) Hipersensibilidad a antihistamínicos H1 o benzimidazoles. (7) Cualquier condición clínica o historia relevante de enfermedad renal, hepática, gastrointestinal, cardiovascular, respiratoria, hematológica, endocrina o neurológica que en opinión del investigador pueda hacer que el sujeto no sea idóneo para el estudio o pueda interferir en el objetivo del mismo. (8) Niños o padres incapaces de cumplir con los requerimientos del estudio (asistencia a las visitas), incapaces de tomar el tratamiento del estudio, o niños que tengan que viajar a otra área geográfica durante el estudio. (9) Niñas que estén embarazadas o dando el pecho. (10) Niños que tengan una historia reciente (dentro de los previos 12 meses) de adicción a las drogas o abuso de alcohol. (11) Participación en otro ensayo clínico dentro de los 30 días previos a la ingesta de la primera dosis de la medicación del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of children without Treatment-Emergent Adverse Events (TEAEs) throughout the course of the study. |
Proporción de niños sin Acontecimientos Adversos Emergentes (AAEs) a lo largo del estudio. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Proportion of children with related TEAEs throughout the course of the study. - Incidence of TEAEs by System and Organ Class (SOC) and Preferred Term (PT) using MedDRA terminology. - Laboratory blood tests (haematology and biochemistry) performed at baseline and end of treatment. - Assessment of cardiac safety by ECG recording at each visit. - Assessment of somnolence or sedation, by means of the Pediatric Sleep Questionnaire (PSQ) at each visit. - Assessment of the child's Quality of Life (QoL) by means of the Paediatric Rhinitis Quality of Life Questionnaire (PRQLQ), and the Children's Dermatology Life Quality Index (CDLQI) to be administered to children according to the relevant disease. QoL scales will be administered at baseline and at the end of treatment. |
- Proporción de niños con AAEs relacionados a lo largo del estudio. - Incidencia de AAEs por sistema orgánico (SOC) y término preferente (PT) usando el diccionario MedDRA. - Análisis de sangre (hematología y bioquímica) realizados en la visita basal y al final del tratamiento. - Evaluación de la seguridad cardiaca por medio de los ECGs realizados en cada visita. - Evaluación de la somnolencia o sedación, usando el Paediatric Sleep Questionnaire (PSQ) en cada visita. - Evaluación de la Calidad de Vida en niños (QoL) por medio del Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), y el Children?s Dermatology Life Quality Index (CDLQI) que se suministrarán a los niños de acuerdo con su enfermedad. Las escalas QoL se administrarán en la visita basal y al final del tratamiento. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial 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
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LVLS |
Última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |