Redesigned study restarts recruitment

young girl having an online asthma appointment and using an inhaler sitting on a sofa at home with laptop

A clinical trial that was significantly changed as a result of COVID-19 has now begun recruiting patients.

The BenRex study is taking place across the country, including at BHP founder-member University Hospitals Birmingham NHS Foundation Trust.

The study, which aims to measure the effectiveness of treating asthma with a drug called benralizumab, stopped recruiting patients in March 2020, in line with the wider pausing of many studies at the time.

The study has been redesigned in a number of ways. These include turning some follow-up appointments into video calls, providing benralizumab as a treatment that patients can give themselves at home, and arranging to collect samples at a separate location to hospitals, which still have to follow COVID-19 guidelines.

Professor Adel Mansur, Thoracic Medicine Consultant and Principal Investigator, said: “The changes to the study were designed to allow us to safely obtain all the information we need while following the ongoing rules.

“The changes we have made are also being evaluated, as we believe they could provide the template for a new way to deliver research studies, including a mixture of remote monitoring and on-site visits.”

Other changes to the study include providing devices for patients to complete exhaled breath and lung function tests, supervised remotely by clinical staff. Patients will also be asked to complete an electronic diary detailing their symptoms.

Mary Bellamy, Lead Research Nurse, added: “The changes to BenRex, which mean we can now collect data remotely and chart any issues before an asthma attack, are a great example of how research teams have adapted to the COVID-19 pandemic.

“After supporting COVID-19 research and frontline care at UHB, the research teams at the Trust are now returning their focus to paused trials.

“I’d like to thank the trial leads and research teams for being so adaptable and helping get this trial back up and running once again.”

The trial aims to recruit all patients by September 2022, with initial results expected in August 2023.

Covid-19 has had a significant impact on non-Covid clinical research, with many studies still paused due to the pandemic.

Working with patient involvement leads and NHS partners, BHP and ABPI have collaborated to produce the Clinical Research Restart Resource as a useful aid to sites and sponsors across the UK who are restarting non-Covid research studies and trials as part of post-pandemic recovery.