An interesting study published in The Lancet Respiratory Medicine Journal April 9th 2021 by Rama Krishnan and others looked at this issue.
It has been noted idiosyncratically that patients admitted to hospital with COVID-19 were under represented if they had chronic respiratory disease.
This study sought to review whether the widespread use of inhaled glucocorticoids amongst these patients was responsible for this.
The researchers performed an open label, parallel group, phase two, randomised controlled trial of inhaled budesonide, and compared with usual care, in adults within seven days of the onset of mild COVID-19 symptoms.
The trial was done in the Oxfordshire community.
Participants were randomly assigned to inhaled budesonide or usual care stratified for age, sex and other comorbidities.
Budesonide dry powder was delivered using a Turbohaler at a dose of 800 mcg per actuation.
Participants were asked to take two inhalations twice a day until symptom resolution.
The primary endpoint was COVID-19 related urgent care visit including emergency department assessment or hospitalisation, analysed for both the per protocol and intention to treat populations.
The secondary outcomes were self-reported clinical recovery i.e. symptom resolution, viral symptoms measured using the common cold questionnaire and influenza patient reported outcome questionnaire, body temperature, blood oxygen saturations and SARS-CoV-2 viral load.
From 16th July to 9th December 2020, 167 participants were recruited and assessed for eligibility.
146 participants remained and were randomly assigned, 73 to usual care and 73 to budesonide.
As per the protocol population, the primary outcome occurred in 10, that is 14% of 70 participants in the budesonide group and 1% of 69 participants in the usual care group.
Within the ITT, the intention to treat population, the primary outcome occurred in 11, 15% participants in the usual care group and 2, 3% participants in the budesonide group.
The number needed to treat with inhaled budesonide to reduce COVID-19 deterioration was eight.
Clinical recovery was one day shorter in the budesonide group compared with the usual care group.
The mean proportion of days with a fever in the first 14 days was lower in the budesonide group than the usual care group and the proportion of participants with at least one day of fever was lower in the budesonide group when compared with the usual care group.
As needed antipyretic medication was required for a fewer proportion of days in the budesonide group compared with the usual care group.
Fewer participants randomly assigned to budesonide had persistent symptoms at days 14 and 28 compared with participants receiving usual care.
Blood oxygen concentrations and SARS-CoV-2 load, measured by cycle threshold, were not different between the two groups.
Budesonide was safe, with only 5, 7% of participants reporting self-limiting adverse effects.
The study concluded that early administration of inhaled budesonide reduced the likelihood of needing urgent medical care and reduced time to recovery after early COVID-19.
This is an interesting study with the use of a cheap and readily available inhaled steroid and the researchers suggest that their findings require urgent validation and dissemination.
The London General Practice is excited by a safe and effective treatment which reduces the symptom duration and symptoms of COVID-19.
Dr Paul Ettlinger
BM, DRCOG, FRCGP, FRIPH, DOccMed