Nasal biomarker inflammatory profile in response to intranasal corticosteroids in pediatric obstructive sleep apnea syndrome

Nasopharyngeal inflammation contributes to pediatric obstructive sleep apnea syndrome (OSAS). Intranasal corticosteroids (INCS) are used to treat pediatric OSAS; a randomized controlled trial (RCT) showed an improvement in OSAS symptoms but without polysomnography or neurobehavioral outcome differences. There is a lack of data demonstrating an objective decrease in the nasal inflammatory biomarker profile (NIBP) associated with INCS. Hence, we evaluated the association of NIBP and response to INCS. Secondary analysis of a RCT of INCS versus placebo in pediatric OSAS (n=134). The difference in intranasal biomarkers (IL-4, IL-13, TNF-alpha) between the groups after 3 and 12 months was evaluated. The association of the NIBP and response to INCS was assessed. Multiple regression analysis was performed to identify clinical predictors of response to INCS. There were no statistically significant differences in the nasal IL-4, IL-13 and TNF-alpha levels between INCS and placebo groups after 3 and 12 months of treatment. Within the INCS group, there was no statistically significant change in the nasal IL-4, IL-13 and TNF-alpha levels after 3 months of therapy based on responder status. However, among those who received INCS, obesity and a higher obstructive apnea-hypopnea index (OAHI) at baseline were clinical predictors of greater OAHI after three months (p = 0.038 and 0.002, respectively). INCS did not affect the NIBP in children with OSAS, including the responders. In addition, INCS is not recommended as a treatment option in children with obesity or high OAHI at baseline. Name: Steroids for Pediatric Apnea Research in Kids (SPARK); URL: https://clinicaltrials.gov/study/NCT02180672; Identifier: NCT02180672.