Asthma exacerbations during the pandemic: Time to rethink clinical markers.

Abstract

BackgroundReductions in asthma exacerbations during the COVID-19 pandemic may have an impact on clinical trial enrollment and outcomes.ObjectiveTo review clinical studies and reports evaluating asthma exacerbations before and during the COVID-19 pandemic.MethodsWe reviewed clinical studies conducted with biologics over the past decade that evaluated asthma exacerbations as the primary endpoint. We also reviewed recent clinical reports evaluating asthma exacerbations during the COVID-19 pandemic.ResultsWe showed that studies which required at least two exacerbations in the prior year resulted in a higher number of exacerbations on study in the placebo arm, and conversely those studies where exacerbations were not required for entering the study failed to meet the primary endpoint. This result confirmed that history of prior exacerbations is a good maker to predict future exacerbations. In addition, a review of the literature confirmed a reduction of asthma exacerbations during the COVID-19 pandemic. Data presented are descriptive; no formal statistics were employed.ConclusionHistorical exacerbations may no longer be the best predictor for exacerbations in a clinical trial/clinical practice due to the COVID-19 pandemic. Other clinical markers associated with exacerbations such as blood eosinophils and exhaled nitric oxide should be considered for enrolment in clinical studies assessing asthma exacerbations.