Severe asthma Respiratory Asthma
Conditions
Interventions
TEZEBIO – 3TR ABC is a multi-centre observational study of patients with severe asthma following initiation of treatment with tezepelumab (anti-TSLP) as part of their standard of care. Participants wi
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult (=18 years old) 2. Clinical decision to initiate tezepelumab for severe asthma after meeting licensing, local and national guidelines 3. Be able to give valid written consent; compliant with study procedures and study visits
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the active substance of tezepelumab 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adequacy of asthma control and change in asthma control measured using the Asthma Control Questionnaire 5 Questions (ACQ5) <1.5, assessed at 1 year 2. Pulmonary function measured using post-bronchodilator (post BD) Forced Expiratory Volume in 1 Second (FEV1) percent predicted, at 1 year 3. Exacerbations history, assessed using medical history at 1 year 4. Oral corticosteroids use, assessed using medical history and current medications at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 30/07/2024: 1. Patient-reported outcomes: 1.1. Adequacy of asthma control and change in asthma control measured using the Asthma Control Questionnaire 5 Questions (ACQ5), assessed at visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52), visit 5 (2 years), visit 6 (3 years). 1.2. Physical and emotional impact of asthma measured using Asthma Quality of Life Questionnaire (AQLQ), assessed at visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52), visit 5 (2 years), visit 6 (3 years). 1.3. Quality of life in people with severe asthma measured using the Self-Assessment Questionnaire (SAQ), assessed at visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52), visit 5 (2 years), visit 6 (3 years). 1.4. Health-related quality of life measured using the EQ5D5L health status questionnaire, assessed at visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52), visit 5 (2 years), visit 6 (3 years). 1.5. Effect of health problems on ability to work and perform regular activities measured using the Work Productivity and Activity Impairment General Health (WPAI:GH) questionnaire, assessed visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52), visit 5 (2 years), visit 6 (3 years). 1.6. Quality of life and symptom control in allergic rhinitis measured using the Sino-Nasal Outcome Test-22 Questionnaire (SNOT22), assessed visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52), visit 5 (2 years), visit 6 (3 years). 1.7. Symptoms associated with dysfunctional breathing patterns measured using the Nijmegen Questionnaire (NQ), assessed visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52), visit 5 (2 years), visit 6 (3 years). 1.8. Subjective measure of sleepiness measured using the Epworth Sleepiness Scale (ESS), assessed visit 1 (week 0), visit 2 (week 4), visit 3 (week 16), visit 4 (week 52), visit 5 (2 years), visit 6 ( | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Contacts
Public ContactBonnie Millar
Outcome results
None listed