E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Respiratory syncytial virus infection |
Infección por el virus respiratorio sincitial |
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E.1.1.1 | Medical condition in easily understood language |
Respiratory virus infection |
Virus respiratorio sincitial |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061603 |
E.1.2 | Term | Respiratory syncytial virus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 primary objectives are to evaluate in infants and children who have been treated with lumicitabine or placebo in Study 64041575RSV2004 during the follow-up period and within 2 years after the RSV infection: • The incidence of the clinical diagnosis of asthma. • The frequency of wheezing. |
Los objetivos principales consisten en evaluar en bebés y niños que han recibido tratamiento con lumicitabina o placebo en el estudio 64041575RSV2004 durante el periodo de seguimiento y en los 2 años posteriores a la infección por el VRS: - La incidencia del diagnóstico clínico de asma. - La frecuencia de las sibilancias. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate during the follow-up period in infants and children who have been treated with lumicitabine or placebo in Study 64041575RSV2004: • The frequency of wheezing over time. • The frequency of wheezing episodes over time. • The long-term safety of lumicitabine. • The frequency and type of respiratory infections. • Medical resource utilization. |
Los objetivos secundarios consisten en evaluar durante el periodo de seguimiento en bebés y niños que han recibido tratamiento con lumicitabina o placebo en el estudio 64041575RSV2004: - La frecuencia de las sibilancias a lo largo del tiempo. - La frecuencia de los episodios de sibilancias a lo largo del tiempo. - La seguridad a largo plazo de la lumicitabina. - La frecuencia y el tipo de infecciones respiratorias. - El uso de recursos médicos |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female infants and children who were previously randomized in Study 64041575RSV2004 for the treatment of RSV infection and who completed the planned course of the study drug and the last study-related visit of Study 64041575RSV2004. 2. The subject’s legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing for the subject to participate in the study. |
1. Bebés y niños de ambos sexos que fueron aleatorizados previamente en el estudio 64041575RSV2004 para el tratamiento de la infección por el VRS y que hayan finalizado el tratamiento programado con el fármaco del estudio y realizado la última visita relacionada con el estudio 64041575RSV2004. 2. El representante legal del sujeto debe firmar un formulario de consentimiento informado (FCI) en el que se indica que entiende la finalidad y los procedimientos necesarios del estudio y que está dispuesto a que el sujeto participe en el estudio. |
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E.4 | Principal exclusion criteria |
1. The subject’s legally acceptable representative, ie, parent/legal guardian/caregiver, is not able to maintain reliable communication with the investigator. 2. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. |
1. El representante legal del sujeto, es decir, progenitor/tutor legal/cuidador, no puede mantener una comunicación fiable con el investigador. 2. Cualquier afección que, en opinión del investigador, haga que la participación no sea lo mejor para el sujeto (p. ej., pusiera en riesgo su bienestar) o pueda impedir, limitar o confundir las evaluaciones especificadas en el protocolo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Clinical diagnosis of asthma within the first 2 years after the RSV infection, as diagnosed by a physician and reported by the parent/caregiver. • Percentage of wheezing days within the first 2 years after the RSV infection, based on information reported by the parent/caregiver. |
- Diagnóstico clínico de asma en los 2 primeros años después de la infección por el VRS, según el diagnóstico de un médico y la información proporcionada por el progenitor/cuidador. El personal del centro del estudio debe recopilar toda la información médica necesaria para confirmar el diagnóstico de asma. - Porcentaje de días de sibilancias en los 2 primeros años después de la infección por el VRS, a partir de la información notificada por el progenitor/cuidador. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Monitored throughout the study |
Monitorizado a lo largo del estudio. |
|
E.5.2 | Secondary end point(s) |
• Percentage of wheezing days per month after the RSV infection, based on information reported by the parent/caregiver. • Number of wheezing episodes after the RSV infection, based on information reported by the parent/caregiver. • Incidence of reportable AEs and SAEs among subjects, based on information reported by the parent/caregiver and judged by the investigator. Reportable AEs include AEs related to respiratory illnesses and AEs considered at least possibly related to lumicitabine or placebo by the investigator. • Number and type of respiratory infections among subjects, based on information reported by the parent/caregiver. • Medical resource utilization including the number of medical visits, emergency room visits, and hospitalizations, all for respiratory conditions only, based on information reported by the parent/caregiver. |
- Porcentaje de días de sibilancias al mes después de la infección por el VRS, a partir de la información proporcionada por el progenitor/cuidador. - Número de episodios de sibilancias después de la infección por el VRS, a partir de la información proporcionada por el progenitor/cuidador. - Incidencia de acontecimientos adversos (AA) y acontecimientos adversos graves (AAG) notificables en los sujetos, a partir de la información proporcionada por el progenitor/cuidador y juzgada por el investigador. Los AA notificables son todos los AA relacionados con enfermedades respiratorias y los AA que el investigador considere posiblemente relacionados con la lumicitabina o con el placebo. - Número y tipo de infecciones respiratorias en los sujetos, a partir de la información proporcionada por el progenitor/cuidador. - Uso de recursos médicos, incluido el número de visitas médicas, visitas a urgencias y hospitalizaciones, todas para afecciones respiratorias únicamente, a partir de la información proporcionada por el progenitor/cuidador. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Monitored throughout the study |
Monitorizado a lo largo del estudio. |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Este estudio es un estudio observacional de seguimiento a largo plazo del estudio 64041575RSV2004 |
This study is an observational long-term follow-up of Study 64041575RSV2004 |
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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 | 3 |
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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 48 |
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 |
Australia |
Austria |
Belgium |
Brazil |
Canada |
Chile |
Colombia |
Czech Republic |
Finland |
France |
Germany |
Hungary |
Ireland |
Israel |
Italy |
Japan |
Korea, Republic of |
Malaysia |
Netherlands |
New Zealand |
Panama |
Poland |
Portugal |
Slovakia |
Spain |
Sweden |
Taiwan |
Thailand |
Ukraine |
United Kingdom |
United States |
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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
|
LVLS |
Úlitma visita del Último paciente |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |