Pharmacies have been advised to use ‘business as usual’ routes to order supplies of inhaled budesonide, after the asthma drug was found to reduce recovery time for Covid-19 patients.
An alert sent to community pharmacies and primary care prescribers yesterday (12 April) said ordering as usual from wholesalers would maintain stock levels to meet ‘both routine use’ and ‘prevailing demand’ for the therapeutic use of the drug in the management of Covid-19.
It followed early results from the PRINCIPLE trial, which is assessing the effectiveness of therapies in primary care to potentially speed up the recovery of Covid positive patients.
The study, published as a pre-print, reported a three-day median benefit in self-reported recovery for patients with Covid in the community setting who received inhaled budesonide, although the impact on hospitalisation rates or mortality has not been established.
The CAS alert said the drug is not currently being recommended as standard of care, but can be considered ‘off-label on a case-by-case basis’ for symptomatic Covid patients aged 65 and over, or aged 50 or over with co-morbidities, in line with the Interim Position Statement.
It added that pharmacy teams should ensure patients or their representatives are aware of how the inhaler should be used and signpost them to additional support, with supplementary information for patients available on the NHS website.
Pharmacies and prescribers will be notified of any national supply restrictions, it also said.
The Government, which funds the PRINCIPLE trial, said that as the evaluation is ongoing ‘recommendations may change as more data become available’.
A statement from all four UK health departments said: ‘At this point in time, inhaled budesonide is not being recommended for routine use, but can be considered to be prescribed by healthcare professionals on a case-by-case basis using the information described in this Interim Position Statement and the interim results from the PRINCIPLE trial (pre-print). This is an off-label use of a licensed medicine, the meaning of which should be discussed with the patient.’
The study, which has not yet been peer-reviewed, involved 1,779 participants who had tested positive for Covid, 751 of whom were randomly assigned to receive inhaled budesonide at home. A further 1,028 patients were randomly assigned the usual standard of NHS care alone.
All participants were aged over 50 with ‘an underlying health condition that put them at more risk of serious Covid-19 illness’ or were over 65 years old, the University of Oxford researchers said.
Early results of the trial found that the estimated median time to self-reported recovery for inhaled budesonide was three days shorter compared to usual care, it added.
Initial data from the study, published on the pre-print server medRxiv, also revealed that 32% of those taking budesonide, compared to 22% in the usual care group, recovered within the first 14 days of starting the trial and subsequently remained well until 28 days.
Among participants who had completed all 28 days of the study by 25 March 2021, 8.5% in the budesonide group were hospitalised with coronavirus compared with 10.3% in the other group.
However, as Covid-19 cases and hospitalisations continue to drop, it is not yet ‘clear from this interim analysis whether budesonide reduces hospitalisations’, the researchers cautioned.
‘A significant milestone’
Joint chief investigator and South Wales GP Professor Chris Butler said: ‘[We have] 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.
‘We therefore anticipate that medical practitioners around the world caring for people with Covid-19 in the community may wish to consider this evidence when making treatment decisions.’
Professor Richard Hobbs, head of Oxford University’s Nuffield Department of Primary Care Health Sciences, added: ‘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.’
He said: ‘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.’
A version of this story first appeared on our sister title, Pulse.