Oxymetazoline plus budesonide spray: 83% responders vs 36% on budesonide alone in a 60-person trial

A single-center, double-blind, randomized clinical trial at Washington University in St Louis/Barnes Jewish Hospital tested a combined oxymetazoline/budesonide nasal spray in adults with chronic nasal obstruction. The results were published in JAMA otolaryngology-- head & neck surgery. The study ran from October 2024 to July 2025 and is registered as NCT06830109 doi.orgJAMA otolaryngology-- head & neck surgerydoi.orgOpen source ↗.

Prolonged use of oxymetazoline, an effective nasal decongestant, is associated with rebound obstruction. Earlier literature suggested that intranasal steroids might prevent tachyphylaxis and rebound. The authors tested whether long-term combined use could relieve obstruction without symptoms or histopathologic signs of rhinitis medicamentosa doi.orgJAMA otolaryngology-- head & neck surgerydoi.orgOpen source ↗.

Trial design and participants

Of 87 people screened, 61 signed informed consent and 60 were randomized and completed baseline assessments. Participants were adults with chronic nasal obstruction who had previously failed topical steroids and had no chronic sinusitis doi.orgJAMA otolaryngology-- head & neck surgerydoi.orgOpen source ↗.

Thirty-one participants received oxymetazoline/budesonide (mean age 46.0 years; 18 female, 13 male). Twenty-nine received budesonide alone (mean age 51.2 years; 17 female, 12 male). Both groups used the spray twice daily for 4 weeks of active treatment, followed by a 3-week wean period. Ten participants had inferior turbinate biopsies before and after treatment for histopathological analysis doi.orgJAMA otolaryngology-- head & neck surgerydoi.orgOpen source ↗.

Responders and rebound

The primary outcome was the share of responders, defined as at least moderate improvement on the Clinical Global Impressions-Improvement scale after 4 weeks. Rebound obstruction and difficulty weaning were assessed by changes in the Clinical Global Impression-Severity score doi.orgJAMA otolaryngology-- head & neck surgerydoi.orgOpen source ↗.

There were 24 of 29 responders (83%) in the oxymetazoline/budesonide arm and 10 of 28 (36%) in the budesonide-only arm. The difference was 47 percentage points (95% CI, 25-70) doi.orgJAMA otolaryngology-- head & neck surgerydoi.orgOpen source ↗.

No participant in the oxymetazoline arm developed worsening obstruction suggestive of rebound during active treatment. All participants successfully weaned off oxymetazoline without issue doi.orgJAMA otolaryngology-- head & neck surgerydoi.orgOpen source ↗.

The authors concluded that for patients with chronic nasal obstruction who fail topical steroids, chronic therapy with the combination may be considered. They noted that the risk of rebound congestion with longer-term use cannot be excluded doi.orgJAMA otolaryngology-- head & neck surgerydoi.orgOpen source ↗.