Nasal Obstruction and Treatment With Oxymetazoline and Corticosteroids: A Randomized Clinical Trial

Prolonged use of oxymetazoline, a highly effective nasal decongestant, is associated with rebound obstruction, but previous literature has shown potential for intranasal steroids to prevent tachyphylaxis and rebound, thereby potentially allowing for long-term combined oxymetazoline/intranasal steroid use in patients with chronic nasal obstruction.

To determine whether long-term combined oxymetazoline/budesonide nasal spray could alleviate the nasal obstruction associated with chronic rhinitis without inducing symptoms or histopathologic evidence of rhinitis medicamentosa.

This study was a single-center, double-blind, randomized clinical trial conducted at Washington University in St Louis/Barnes Jewish Hospital from October 2024 to July 2025. Key selection criteria included adults with chronic nasal obstruction, prior failure of topical steroids, and no chronic sinusitis.

Participants used a provided nasal spray twice daily containing either oxymetazoline/budesonide or budesonide alone for 4 weeks of active treatment followed by a 3-week wean period. Ten participants underwent pretreatment and posttreatment inferior turbinate biopsies for histopathological analysis of change.

The primary outcome measure is the rate of responders, defined as at least moderate improvement on the Clinical Global Impressions-Improvement scale, assessed after 4 weeks of treatment. Measures of rebound obstruction or difficulty weaning were assessed by score changes on the Clinical Global Impression-Severity scale.

From 87 individuals screened, 61 participants signed informed consent, and 60 participants were randomized and completed baseline assessments. Of the randomized participants, 31 participants received oxymetazoline/budesonide spray (mean [SD] age at enrollment, 46.0 [18.7] years; 18 [58.1%] female; 13 [41.9%] male), and 29 participants received budesonide alone (mean [SD] age, 51.2 [17.1] years; 17 [58.6%] female; 12 [41.4%] male). There were 24 of 29 (83%) responders to treatment in the oxymetazoline/budesonide arm, compared with 10 of 28 (36%) in the budesonide-only arm, a difference of 47 percentage points (95% CI, 25-70 percentage points). None of the participants in the oxymetazoline arm developed worsening obstruction concerning for rebound obstruction during active treatment. All successfully weaned off oxymetazoline without issue.

In this randomized clinical trial, there was a large and clinically meaningful greater proportion of responders in the oxymetazoline arm, without signs or symptoms of rhinitis medicamentosa during the study. All participants successfully weaned off oxymetazoline. For patients with chronic nasal obstruction failing topical steroids, chronic therapy with combination oxymetazoline/budesonide may be considered, though risks of rebound congestion with longer-term use cannot be excluded.

ClinicalTrials.gov Identifier: NCT06830109.