“Significant milestone” for inhaled budesonide benefit as early COVID-19 therapy


By Dave Levitan

13 Apr 2021

Inhaled budesonide can reduce the likelihood of requiring urgent medical care for a COVID-19 infection, and can shorten recovery time as well, according to two studies. Results of the STOIC trial are now fully peer reviewed, while the larger PRINCIPLE trial has offered its first results on the treatment.

“PRINCIPLE, the world’s largest platform trial of community-based treatments for COVID-19, has found evidence that a relatively cheap, widely available drug with very few side effects helps people at higher risk of worse outcomes from COVID-19 recover quicker, stay better once they feel recovered, and improves their wellbeing,” said Professor Chris Butler, a professor at Oxford University and joint chief investigator of the trial.

The interim analysis of the PRINCIPLE trial included a total of 751 people with early COVID-19 treated with inhaled budesonide, and 1,028 patients who received usual care. The median time to self-reported recovery was just over three days (3.011) shorter with budesonide than with usual care.

In the budesonide group, 32% recovered within the first 14 days from randomisation and remained well through 28 days, compared with 22% in the usual care group. Patients who received budesonide also reported greater wellbeing after two weeks.

Hospitalisation was also less likely with budesonide, at 8.5% compared with 10.3% in the usual care group. This was a lower hospitalisation rate than expected, however, and it is not yet clear if the therapy significantly reduces hospitalisation risk.

Results of the smaller STOIC trial, which were first reported earlier this year, have now been published in Lancet Respiratory Medicine. They show that patients randomised to receive budesonide were less likely to require urgent medical care, including emergency department assessment or hospitalisation, than those receiving usual care.

In an intention-to-treat analysis, 15% of those receiving usual care were hospitalised, compared with only 3% of those who received inhaled budesonide. The number needed to treat in order to reduce COVID-19 deterioration was eight.

At days 14 and 28, fewer patients who received inhaled budesonide had persistent symptoms than those who received usual care.

“For the first time we have high-quality evidence of an effective treatment that can be rolled out across the community for people who are at most risk of developing more severe illness from COVID-19,” said Professor Richard Hobbs, also of Oxford University and a joint chief investigator of the PRINCIPLE trial.

“Unlike other proven treatments, budesonide is effective as a treatment at home and during the early stages of the illness. This is a significant milestone for this pandemic and a major achievement for community-based research.”

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