As-needed vs regular intranasal corticosteroid therapy in pediatric perennial allergic rhinitis: A randomized double-dummy trial.

BACKGROUND

Intranasal corticosteroids (INCS) are the most effective monotherapy for allergic rhinitis (AR), but daily adherence remains challenging. Evidence comparing regular vs as-needed INCS use in pediatric perennial AR (PAR) is limited.

OBJECTIVE

To evaluate the efficacy, safety, and anti-inflammatory effects of regular vs as-needed INCS in pediatric PAR.

METHODS

In this 8-week, randomized, double-blind, double-dummy trial, 70 children aged 6 to 18 years with PAR were assigned (1:1) to regular or as-needed intranasal fluticasone furoate. Key outcomes included total, total nasal, and total ocular symptom scores (TSS, TNSS, and TOSS, respectively); Visual Analog Scale (VAS); parent-assessed scores (P-); Rhinoconjunctivitis Quality of Life-36; peak nasal inspiratory flow; nasal cytology; INCS exposure; and adverse events.

RESULTS

A total of 68 patients completed the trial (as-needed, n = 33; regular, n = 35). Regular treatment demonstrated greater improvements in TSS, TNSS, TOSS, VAS, PVAS, and peak nasal inspiratory flow than as-needed treatment at selected early time points (all P < .05). However, these differences were not sustained to week 8. No significant between-group differences were observed in PTSS, PTNSS, PTOSS, or Rhinoconjunctivitis Quality of Life-36 scores. At week 8, regular treatment resulted in greater reductions in mucosal eosinophils and basophilic metachromatic cells (P < .05). Cumulative INCS exposure was lower with as-needed treatment (P < .05). Adverse events were comparable, although epistaxis occurred only in the as-needed group (P = .02).

CONCLUSION

Regular INCS use was associated with greater early clinical and anti-inflammatory benefits than as-needed use in pediatric PAR, without increased adverse events. However, between-group clinical differences were not sustained to week 8. As-needed treatment also improved outcomes from baseline and may be an alternative for symptom control in selected patients.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05299086.