Long term study of Lumicitabine in young children after RSV infection
Research type
Research Study
Full title
A Long-term Follow-up of Study 64041575RSV2004 to Evaluate the Impact of Lumicitabine (JNJ-64041575) on the Incidence of Asthma and/or Wheezing in Infants and Children with a History of Respiratory Syncytial Virus Infection
IRAS ID
236096
Contact name
Adam Finn
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2016-002095-26
Duration of Study in the UK
3 years, 3 months, 30 days
Research summary
Respiratory Syncytial Virus (RSV) is a seasonal virus that can affect people of all ages. In older children and adults it produces symptoms similar to the common cold, and after about a week these will largely be overcome. However in infants and young children RSV can lead to serious and even life threatening lower respiratory tract infection (LRTI), for which there is no effective current treatment.
This study follows on directly from clinical trial 64041575RSV2004, which is trialling lumicitabine in a target population of infants from 28 days to 36 months hospitalised with RSV and aimed to determine the response in terms of suppressing the virus with the administration of lumicitabine at different doses when compared to a placebo.
Study 64041575RSV2002 is a non-interventional long term follow up (LTFU) study of participants who have successfully completed the 64041575RSV2004 study. Its primary purpose is to follow participants for a period of 2 years (with a possible extension to take it up to 5 years) in order to evaluate in a real world context the impact of the RSV and its treatment on the health and wellbeing of the participants, their parent(s)/ caregiver(s) and family. The main objectives include ascertaining incidences of asthma, wheezing, allergic rhinitis, other respiratory conditions, or eczema; broader objectives will explore the effect on the everyday lives and normal functioning of the participants and their families. The double blinding that applied in the earlier treatment trial will be maintained throughout the course of this non-interventional study.
The age of the target population has meant that extra care is needed to ensure the safety of the participants in the previous interventional trial, however as this study is non-interventional it has the potential to extract the most comprehensive data possible from the previous study without involving additional risk.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0468
Date of REC Opinion
11 Jun 2018
REC opinion
Further Information Favourable Opinion