Effect of an Intranasal Corticosteroid on Quality of Life and Local Microbiome in Young Children With Chronic Rhinosinusitis

Abstract

ImportanceIntranasal corticosteroids (INCs) remain the first-line treatment of chronic rhinosinusitis (CRS) in both adults and children, despite the lack of evidence regarding their efficacy in the pediatric population. Similarly, their effect on the sinonasal microbiome has not been well documented.ObjectiveTo assess the clinical, immunological, and microbiological effects of 12 weeks of an INC in young children with CRS.Design, Setting, and ParticipantsThis open-label randomized clinical trial was performed in a pediatric allergy outpatient clinic in 2017 and 2018. Children aged 4 to 8 years with CRS diagnosed by a specialist were included. Data were analyzed from January 2022 to June 2022.InterventionsPatients were randomized to receive intranasal mometasone in an atomizer for 12 weeks (1 application per nostril, once per day) and supplemental 3-mL sodium chloride (NaCl), 0.9%, solution in a nasal nebulizer once a day for 12 weeks (INC group) or 3-mL NaCl, 0.9%, solution in a nasal nebulizer once a day for 12 weeks (control group).Main Outcomes and MeasuresMeasures taken both before and after treatment included the Sinus and Nasal Quality of Life Survey (SN-5), a nasopharynx swab for microbiome analysis by next-generation sequencing methods, and nasal mucosa sampling for occurrence of innate lymphoid cells (ILCs).ResultsOf the 66 children enrolled, 63 completed the study. The mean (SD) age of the cohort was 6.1 (1.3) years; 38 participants (60.3%) were male and 25 (39.7%) were female. The clinical improvement reflected by reduction in SN-5 score was significantly higher in the INC group compared with the control group (INC group score before and after treatment, 3.6 and 3.1, respectively; control group score before and after treatment, 3.4 and 3.8, respectively; mean between-group difference, −0.58; 95% CI, −1.31 to −0.19; P = .009). The INC group had a greater increase in nasopharyngeal microbiome richness and larger decrease in nasal ILC3 abundance compared with the control group. A significant interaction was observed between change in microbiome richness and the INC intervention on the prediction of significant clinical improvement (odds ratio, 1.09; 95% CI, 1.01-1.19; P = .03).Conclusions and RelevanceThis randomized clinical trial demonstrated that treatment with an INC improved the quality of life of children with CRS and had a significant effect on increasing sinonasal biodiversity. Although further investigation is needed of the long-term efficacy and safety of INCs, these data may reinforce the recommendation of using INCs as a first-line treatment of CRS in children.Trial RegistrationClinicalTrials.gov Identifier: NCT03011632

The Impact of Antibiotics and Steroids on the Nasal Microbiome in Patients with Chronic Rhinosinusitis: A Systematic Review According to PICO Criteria

“…Furthermore, the authors demonstrated that the increase in bacterial diversity was correlated with the decrease in clinical symptoms, suggesting a possible causal relationship. Therefore, they conclude by stating that treatment with an INC improved the quality of life of children with CRS [20]. In another paper, Liu et al evaluated the impact of topical budesonide and saline irrigations on the postsurgical sinonasal microbiota by examining the nasal and sinus swabs of twenty-eight controls and fourteen patients with refractory CRSwNP.…”

“…Regarding the role of topical steroids, while Liu et al found no significant changes in the nasal microbiome when treating patients with topical budesonide, Latek et al demonstrated that treatment with topical mometasone had a significant effect on improving sinonasal biodiversity and improving the QoL of young patients [20,21].…”

Biologic Therapy in Pediatric Chronic Rhinosinusitis: A Systematic Review

“…Additionally, Streptobacillus and Staphylococcus abundance were consistently correlated with age in both adenoid‐ and sinus‐derived samples. Finally, an open‐label randomized controlled trial assessing pediatric CRS with intranasal corticosteroid treatment leads to a greater increase in nasopharyngeal microbiome richness and a larger decrease in nasal Type 3 Innate Lymphoid Cell abundance 26 . These collective findings suggest pediatric CRS has distinct characteristics and behaviors when compared to adult CRS 27 …”

Infectious disease for the rhinologist

“…However, there was an objective increase in the abundance and diversity of the nasal microbiome in posttransplant patients, which authors attributed the symptom improvements to. In a group of pediatric CRS patients, treatment with intranasal corticosteroids for 12 weeks was found to be associated with a greater increase in nasopharyngeal microbiome biodiversity, with a concomitant decrease in nasal innate lymphoid cell abundance and improvement in quality of life scores [2,3,42].…”