(Reuters Health) – The combination of inhaled and intranasal ciclesonide isn’t significantly better than placebo for improving symptoms like cough, dyspnea or fever in younger adults with COVID-19 treated in outpatient settings, a recent study suggests.
For the study, researchers randomized 203 adults aged 18 years and older who presented with mild COVID-19 symptoms like cough, dyspnea, or fever to receive either inhaled ciclesonide (600 micrograms twice daily) and intranasal ciclesonide (200 mcg daily) or to receive a placebo metered dose inhaler and nasal saline for 14 days.
By day 7, a similar proportion of people in the intervention group (40%) and the control group (35%) had a resolution of these mild symptoms of COVID-19. The absolute adjusted risk difference was 5.5%, researchers report in The BMJ.
“We were surprised by this finding as a large study had demonstrated an effect of steroids in hospitalized patients requiring oxygen,” said lead study author Dr. Nicole Ezer, a respirologist at the McGill University Health Centre and an assistant professor of medicine at McGill University in Montreal.
“We were hoping to see a similar effect in outpatients who had a predominance of respiratory symptoms, especially given a suggestion of efficacy in open label studies from the U.K.,” Dr. Ezer said by email.
Due to the results after one week, researchers stopped the trial early.
The median age of participants in the study was 35 years (interquartile range 27 to 47 years) and 54% were women.
In addition, the majority of participants in the intervention group (82%) and the placebo group (78%) had no comorbidities.
It’s possible that the participants were too young, and too healthy for the intervention to show a statistically significant improvement in respiratory symptoms, the study team notes.
One limitation of the study, the authors note, is that they were unable to recruit their intended sample size due to the introduction of vaccines in Canada and a rapid decline in COVID-19 cases during the study period. The trial may have been underpowered to detect small but statistically significant differences between the steroid therapy and placebo, the authors conclude.
“The take-home message is that we were unable to demonstrate a benefit of inhaled and nasal steroids for COVID-19 in younger patients in this randomized placebo controlled trial,” Dr. Ezer said. “The jury is still out in the older patients, who may still benefit from these type of inhaled steroids.”
SOURCE: https://bit.ly/3n82z4Y The BMJ, online November 2, 2021.
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