E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Respiratory syncytial virus infection |
Infezione da virus respiratorio sinciziale |
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E.1.1.1 | Medical condition in easily understood language |
Respiratory virus infection |
Infezione virale respiratoria |
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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 | 21.1 |
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.
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Gli obiettivi primari consistono nel valutare in neonati e bambini che sono stati trattati con lumicitabina o placebo nello studio 64041575RSV2004 durante il periodo di follow-up ed entro 2 anni dopo l¿infezione da RSV: ¿ l¿incidenza della diagnosi clinica di asma; ¿ la frequenza di sibilo.
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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. |
Gli obiettivi secondari consistono nel valutare durante il periodo di follow-up in neonati e bambini che sono stati trattati con lumicitabina o placebo nello studio 64041575RSV2004: ¿ la frequenza di sibilo nel tempo; ¿ la frequenza degli episodi di sibilo nel tempo; ¿ la sicurezza a lungo termine della lumicitabina; ¿ la frequenza e il tipo di infezioni respiratorie; ¿ uso delle risorse mediche.
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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. Neonati e bambini di ambo i sessi che siano stati precedentemente randomizzati nello studio 64041575RSV2004 per il trattamento dell’infezione da RSV e che abbiano completato il ciclo previsto del farmaco in studio e l’ultima visita correlata allo studio nell’ambito dello studio 64041575RSV2004. 2. Il rappresentante legalmente accettabile del soggetto deve firmare un modulo di consenso informato (ICF) indicando di comprendere lo scopo dello studio e le procedure da esso richieste e di acconsentire alla partecipazione del soggetto allo studio.
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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.
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1. Il rappresentante legalmente accettabile del soggetto, ovvero il genitore/tutore legale/caregiver, non è in grado di mantenere una comunicazione affidabile con lo sperimentatore. 2. Qualsiasi condizione per cui, secondo l’opinione dello sperimentatore, la partecipazione non sarebbe nel migliore interesse del soggetto (es. comprometterebbe il suo benessere) o che potrebbe impedire, limitare o alterare le valutazioni specificate dal protocollo.
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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. |
• Diagnosi clinica di asma entro i primi 2 anni dopo l’infezione da RSV, diagnosticata da un medico e riferita dal genitore/caregiver. Tutte le informazioni mediche necessarie a confermare la diagnosi di asma devono essere raccolte dal personale del centro dello studio. • Percentuale di giorni con sibilo nei primi 2 anni dopo l’infezione da RSV, basata sulle informazioni riferite dal genitore/caregiver.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Monitored throughout the study |
Monitorato durante lo studio |
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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. |
¿ Percentuale di giorni con sibilo al mese dopo l¿infezione da RSV, basata sulle informazioni riferite dal genitore/caregiver. ¿ Numero di episodi di sibilo al mese dopo l¿infezione da RSV, basata sulle informazioni riferite dal genitore/caregiver. ¿ Incidenza di eventi avversi (AE) segnalabili ed eventi avversi gravi (SAE) tra i soggetti, basata sulle informazioni riferite dal genitore/caregiver e giudicata dallo sperimentatore. Gli AE segnalabili comprendono AE correlati a malattie respiratorie e AE considerati almeno possibilmente correlati a lumicitabina o placebo dallo sperimentatore. ¿ Numero e tipo di infezioni respiratorie tra i soggetti, in base alle informazioni riferite dal genitore/caregiver. ¿ Utilizzo delle risorse mediche compreso il numero di visite mediche, visite al pronto soccorso e ricoveri, in tutti i casi soltanto per patologie respiratorie, in base alle informazioni riferite dal genitore/caregiver.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Monitored throughout the study |
Monitorato nel corso dello studio |
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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 |
Studio osservazionale a lungo termine follow-up dello studio 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 | 5 |
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 | Information not present in EudraCT |
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 |
Brazil |
Canada |
Chile |
Colombia |
Israel |
Japan |
Korea, Republic of |
Malaysia |
New Zealand |
Panama |
Taiwan |
Ukraine |
United States |
Austria |
Belgium |
Czechia |
Finland |
France |
Germany |
Hungary |
Ireland |
Italy |
Netherlands |
Poland |
Portugal |
Slovakia |
Spain |
Sweden |
United Kingdom |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 18 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 18 |