Determine the association between RSV/bronchiolitis episodes in young children and subsequent childhood episodes of wheeze and asthma (up to age 10 years), using a birth cohort

Study type
Protocol
Date of Approval
Study reference ID
18_261
Lay Summary

Respiratory Syncytial Virus (RSV) causes respiratory infections in young children, such as bronchitis (infection of the airways of the lungs resulting in cough, sore throat, phlegm), bronchiolitis or pneumonia. The symptoms associated with RSV infection could be more or less severe depending, for example, the age of the patient or whether the patient had other health disorders or diseases. This study will use data already collected and available in the Clinical Practice Research Datalink in order to understand how this particular virus affects patients in short and long term and how it impacts the National Health Service (NHS) by examining subsequent wheeze and asthma episodes in GP and hospital attendances, outpatient visits, and deaths. It will also examine who is more at risk to develop severe disease associated with RSV, e.g., premature babies (born before 37 gestational weeks), children with heart and lung disease. The results of this study will be published and presented at medical conferences.

Technical Summary

Respiratory Syncytial Virus (RSV) is the most important cause of lower respiratory tract illness in young children worldwide and considered one of the world's greatest unmet vaccine needs. However, the current knowledge on the disease is insufficiently detailed to underpin evidence-based decision-making on new RSV prevention strategies and therapeutics.
This study will determine the association between RSV/bronchiolitis episodes in young children and subsequent childhood episodes of wheeze and asthma (up to age 10 years) through analysis of data collected in CPRD, linked to Hospital Episode Statistics (HES), pregnancy register, Baby Mother Link, and Office for National Statistics (ONS) death registration data. A retrospective cohort of all eligible patients for linkage with HES/ONS data, born between 2001 and 2007, will be used. The exposed group will consist of all those with a bronchiolitis event (all events, those coded as being due to RSV, those within the RSV season), relative to those without bronchiolitis within their 2 years of follow-up defined as the unexposed group. Kaplan Meier analysis will be conducted to assess the impact of bronchiolitis exposure before the 2 years old on the occurrence of the first events defined by asthma or wheeze episode. Multivariate cox models will be performed to adjust for other relevant variables e.g. demographics, socio-economics status, risk conditions, perinatal and maternal characteristics.

Health Outcomes to be Measured

Hospitalisation for Bronchiolitis, Wheeze, and Asthma; Outpatient visit for Bronchiolitis, Wheeze, and Asthma;
Primary care episode for Bronchiolitis, Wheeze, and Asthma; Death for Wheeze and Asthma as cause; Demographics; Comorbidities; Maternal characteristics; Perinatal characteristics

Collaborators

Caroline Amand - Chief Investigator - Sanofi Winthrop Industrie (France)
Sabine Tong - Corresponding Applicant - Sanofi Aventis Recherche & Développement (France)
Clarisse Demont - Collaborator - Sanofi Pasteur MSD ( closed )
Harry Campbell - Collaborator - University of Edinburgh
Rachel Reeves - Collaborator - University of Edinburgh

Linkages

CPRD Mother-Baby Link;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Pregnancy Register