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

Study objectives: 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.

Methods: 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.

Results: 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).

Conclusions: 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.

Clinical trial registration: Name: Steroids for Pediatric Apnea Research in Kids (SPARK); URL: https://clinicaltrials.gov/study/NCT02180672; Identifier: NCT02180672.