Inhaled corticosteroid added to COVID-19 PRINCIPLE trial

The PRINCIPLE trial is investigating budesonide as a treatment for COVID-19 patients who are not in hospital.

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Budesonide, an inhaled corticosteroid, is the latest drug to be investigated as a treatment for COVID-19 patients who are not in hospital as part of the Platform Randomised Trial of Interventions against COVID-19 in Older People (PRINCIPLE) trial.

Led by the University of Oxford, the PRINCIPLE trial is evaluating treatments that can help people aged over 50 years recover quickly from COVID-19 illness and prevent the need for hospital admission. So far, the trial has recruited more than 2,100 volunteers from across the UK.

In some patients with COVID-19, the body’s immune response to the virus can cause high levels of inflammation that can damage cells in the airways and lungs. Inhaling budesonide, which is often used to treat asthma and COPD, into the airways helps to direct the anti-inflammatory treatment, potentially minimising lung damage that might otherwise be caused by the virus.

Study participants will be assigned randomly to receive the treatment in the post, alongside usual care from the GP. They will be instructed to take the inhaled corticosteroid twice per day for 14 days, with each puff providing a 400 microgram dose of budesonide.

Participants will then be followed for 28 days and their outcomes compared with participants who were randomised to receive usual care only.

“Budesonide is a relatively cheap, safe and easy-to-administer drug for respiratory conditions, that may have a role to play in treating COVID-19,” said Chris Butler, professor of primary care in the Nuffield Department of Primary Care Health Sciences and lead of the PRINCIPLE trial.

“It is only through enrolling volunteers on a randomised controlled trial like PRINCIPLE that we can assess whether there are clear benefits or harms associated with potential treatments like budesonide.”

However, Butler said that the trial still needed “many more” volunteers in order to answer the question of how to keep people with COVID-19 out of hospital.

Richard Hobbs, professor of primary care health sciences and co-lead of the trial, said that it was known from hospital-based trials that intravenous corticosteroid treatment with dexamethasone can reduce mortality in patients who are already hospitalised.

“If we find that budesonide is an effective way of treating COVID-19 illness and preventing hospital admission, then it could be rolled out quickly across the UK following regulatory approval.”

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Citation
The Pharmaceutical Journal, PJ December 2020, Vol 305, No 7944;305(7944)::DOI:10.1211/PJ.2020.20208609