Preschool wheeze: Inflammation/Infection Guided Management (PrIGMa) v1

• Research type

  Research Study

• Full title

  Use of pathological phenotype to determine optimal management for moderate to severe preschool wheeze

• IRAS ID

  165460

• Contact name

  Sejal Saglani

• Contact email

  s.saglani@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  3 years, 9 months, 27 days

• Research summary

  Title: Is treatment of preschool children with wheezing based on infection and inflammation better than current clinical guidelines?

  One-third of all preschool children under 5 years have frequent wheezing and breathlessness which is very difficult to treat. Currently, symptom pattern is used to decide treatment, but this is very crude and inexact. Preschool children account for three-quarters of all paediatric hospital admissions in the UK for wheezing attacks, and this figure has not changed for over a decade. Previous research has shown some preschool wheezers have inflammation caused by cells called eosinophils in their blood and breathing tubes (airways), while others have bacterial infection. This project will determine whether precisely targeting treatment according to the presence or absence of inflammation and infection is better than the current approach of using symptoms alone.
  Children aged between 1 and 5 years with wheezing, attending the Royal Brompton Hospital outpatient clinics will be eligible. They will undergo blood and sputum tests to assess inflammation and infection in their airways and be randomised to receive treatments determined by inflammation (inhaled steroids) or infection (antibiotics), or they will continue to be treated as directed by their Consultant according to current clinical guidelines for four months. The impact of the treatment regimen on need for emergency healthcare and quality of life for the child and family will be used to determine which approach is better.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  15/LO/0050

• Date of REC Opinion

  30 Jan 2015

• REC opinion

  Further Information Favourable Opinion