Wayfinder
Northern Ireland Clinical Research Facility
- Principal Investigator: Professor Liam Heaney
- Name of the Study: A Multicentre, Single-arm, Phase 3b Efficacy and Safety Study of Tezepelumab 210mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Participants with Severe Asthma on High-dose Inhaled Corticosteroid plus Long-acting β2 Agonist and Long-Term oral Corticosteroid Therapy (WAYFINDER).
- Short name: WAYFINDER
- Why is this important?
Asthma is a syndrome characterised by airway inflammation, reversible airway obstruction, and airway hyper-responsiveness. Asthma is a leading cause of morbidity with a global prevalence of approximately 300 million; it is estimated that the number of people with asthma may increase to 400 to 450 million people worldwide by 2025.
- What is the Research question / aim?
This study aims to assess the ability of Tezepelumab to reduce prescribed OCS dose without loss of asthma control in adult participants with OCS-dependent asthma. Asthma is a syndrome characterised by airway inflammation, reversible airway obstruction, and airway hyper-responsiveness.
- What the Study involves:
This is a single-arm, multicentre study in participants with severe asthma who are receiving a high-dose ICS / LABAS and OCS with or without additional asthma controller(s). The study will be divided in 4 periods: Screening, induction phase, OCS reduction and Maintenance phase, and follow-up. Approximately 300 participants from around 90 sites in approximately 10 countries will enter the induction phase. There will be a total of 16 study visits over a period of 64 weeks. The final study visit will take place by phone, all others will take place in the hospital.
- Who can take part in the Study?
This study is only open to patients referred to the Regional Severe Asthma Service.
Location:
NI Clinical Research Facility,
U Floor, Belfast City Hospital,
Lisburn Road, Belfast, BT9 7AB
Tel:+44 (0)28 9504 0342
Email:NICRF@qub.ac.uk