Severe asthma Respiratory
Conditions
Interventions
DUPIBIO – 3TR ABC is a multi-centre observational study of patients with severe asthma following initiation of treatment with dupilumab (anti-IL4Ra) as part of their standard of care. Participants wil
reviewed throughout the year with formal clinical and biological assessment at 4, 16 and 52 weeks. Asthma remission will be defined for each domain: asthma control, lung function, and exacerbations as
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (=18 years old) 2. Clinical decision to initiate dupilumab for severe asthma after meeting licensing, local and national guidelines. 3. Be able to give valid written consent. Participants should have reasonable understanding of the English language (assessed by the research team) 4. Be compliant with study procedures and study visits.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the active substance of dupilumab or any of the excipients 2. Participation in an interventional clinical trial within 3 months of visit 1 or receipt of any investigational medicinal product within 3 months or 5 half-lives. Participation in other observational studies is acceptable if, in the view of the investigator, it will not impact the study outcomes. 3. Other clinically significant medical disease or uncontrolled concomitant disease that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study. 4. Subjects on regular oral corticosteroids (OCS) and whereby the administration of dupilumab for OCS reduction will not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures are assessed at 1 year: 1. Asthma control measured using the Asthma Control Questionnaire 5 Questions (ACQ5) <1.5 2. Lung function post-bronchodilator (post-BD) Forced Expiratory Volume in 1 Second (FEV1) percent predicted measured using spirometry 3. Exacerbations history measured using the patient's medical notes | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 30/07/2024: 1. Patient-reported outcomes: 1.1. Asthma Control Questionnaire 5 Questions (ACQ5), assessed at visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52). 1.2. The Asthma Quality of Life Questionnaire (AQLQ), assessed at visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52). 1.3. Self-Assessment Questionnaire (SAQ), assessed at visit 1 (week 0), Visit 2 (week 4), visit 3 (week 16), visit 4 (week 52). 1.4. EQ5D5L health status questionnaire, assessed at visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52). 1.5. Work Productivity and Activity Impairment Questionnaire General Health (WPAI:GH), assessed visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52). 1.6. Sino-Nasal Outcome Test-22 Questionnaire (SNOT22), assessed visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52). 1.7. Nijmegen Questionnaire (NQ), assessed visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52). 1.8. Epworth Sleepiness Scale (ESS), assessed visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52). 1.9. Hospital Anxiety and Depression Scale (HADS), assessed visit 1 (week 0), visit 2 (week 2), visit 3 (week 16), visit 4 (week 52). 1.10. Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale, assessed at visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52). 1.11. Cognitive Failures Questionnaire, Screen for Cognitive Impairment in Psychiatry (SCIP), Trail Making test (TMT) part B (specific sites), assessed at visit 1 (week 0), visit 3 (week 16) and visit 4 (week 52). 1.12. Global evaluation treatment efficacy (GETE), patient and physician-related response, assessed at visit 2 (week 4), visit 3 (week 16), visit 4 (week 52). 1.13. Visual analogue scale (VAS) scale 3TR question (patient and physician perceived), assessed at visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Contacts
Public ContactBonnie Millar
Outcome results
None listed