ABSTRACT
Background: Reductions in asthma exacerbations during the COVID-19 pandemic may have an impact on clinical trial enrollment and outcomes. Objective: To review clinical studies and reports evaluating asthma exacerbations before and during the COVID-19 pandemic. Methods: We 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. Results: We 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. Conclusion: Historical 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.
ABSTRACT
Human rhinoviruses (RVs) are the primary aetiological agent of the common cold. Generally, the associated infection is mild and self-limiting, but may also be associated with bronchiolitis in infants, pneumonia in the immunocompromised and exacerbation in patients with pulmonary conditions such as asthma or chronic obstructive pulmonary disease. Viral infection accounts for as many as two thirds of asthma exacerbations in children and more than half in adults. Allergy and asthma are major risk factors for more frequent and severe RV-related illnesses. The prevalence of RV-induced wheezing will likely continue to increase given that asthma affects a significant proportion of the population, with allergic asthma accounting for the majority. Several new respiratory viruses and their subgroups have been discovered, with various degrees of relevance. This review will focus on RV infection in the context of the epidemiologic evidence, genetic variability, pathobiology, clinical studies in the context of asthma, differences with other viruses including COVID-19 and current treatment interventions.