Abstract
Introduction: The COVID-19 pandemic caused major disruption to clinical research; asthma trials involving spirometry and induced sputum ground to a halt. BenRex (NCT04102800), an open-label study to characterise asthma exacerbations in patients treated with benralizumab, suspended recruitment in March 2020.
Aim: To redesign the BenRex study to safely obtain clinical, physiological and airway inflammation data despite an ongoing pandemic.
Methods and Results: Study visits, tests and sample collections were reviewed and revised [Table] and ethics approval obtained for the changes.
| Original Study Design [and Problem] | Revised Study Design |
| All 13 visits on site [involving travel and face-to-face attendance] | 7 Visits changed to video calls |
| Study injections administered by research nurse | Use of auto-injectors and training patients to self-inject. Homecare offered after 6 months |
| FeNO testing on site | Home FeNO monitoring three times a week (Vivatmo me, Bosch, Germany) |
| Spirometry on site, at all visits | Test only at key visits and home spirometer used (Vitalograph Micro, Vitalograph, UK) with video supervision |
| Induced sputum cell counts and biomarkers | Spontaneous sputum collected at home for cell counts and nasosorption added for biomarkers |
| Microbiome from induced sputum |
Use spontaneous sputum and oral gargle for microbiome. |
Conclusion: The changes outlined will be evaluated in this study and could pave the way for a new model of respiratory research, offering greater safety to patients and staff and reduction in physical study visits.
Acknowledgements: AstraZeneca [BenRex funder], BenRex TSC, RASP-UK and the 3TR IMI 2 Joint Undertaking (No 831434) [support to SJ Smith].
Footnotes
Cite this article as: European Respiratory Journal 2021; 58: Suppl. 65, PA1108.
This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2021
