Adding corticosteroids to oxymetazoline increased treatment response while avoiding the rebound congestion associated with long-term oxymetazoline use in adults with chronic rhinitis, based on data from a new randomized clinical trial.

Extended use of oxymetazoline as a nasal decongestant has been associated with rebound congestion (rhinitis medicamentosa) in patients with chronic rhinitis, but previous studies have shown adding intranasal steroids may prevent rebound, according to Lucas Cruz, MD, MSCI, and colleagues at Washington University School of Medicine, St. Louis.

Therefore, a combination of oxymetazoline and intranasal steroids might relieve nasal congestion without rebound, but data on the response to this combination are limited, the researchers said.

“As a sinonasal surgeon, I often see patients with nasal obstruction,” said corresponding author Nyssa Fox Farrell, MD, associate professor of otolaryngology-head & neck surgery at Washington University School of Medicine. Current medical options for these patients are limited primarily to topical steroids such fluticasone and topical antihistamines like azelastine, she said.

For patients who fail those medications, some may proceed with surgery, but the minimally invasive procedures, such as absorbable nasal implant or nasal valve remodeling, are often not covered by insurance, she noted. Additionally, more invasive surgeries, such as inferior turbinate reduction, septoplasty, and open septorhinoplasty, are not always appropriate for the patients. “For example, my elderly, sick patients may not be good surgical candidates; in those cases, patients have no option other than to live with their nasal obstruction,” Farrell said.

In the study, published in JAMA Otolaryngology-Head & Neck Surgery, the researchers identified 60 individuals with chronic nasal obstruction but without chronic sinusitis who had a history of failed treatment with topical steroids. Of these, 31 were randomized to oxymetazoline/budesonide spray and 29 to budesonide spray only, used twice daily for 4 weeks and followed by a 3-week weaning period. The median ages of the participants in the two groups were 46.0 years and 51.2 years, respectively, and approximately 58% of each group were women.

Treatment response was defined as a minimum moderate improvement on the Clinical Global Impressions-Improvement scale after 4 weeks, with measures of rebound obstruction or weaning difficulty based on score changes on the Clinical Global Impressions-Severity scale.

Overall, participants in both groups experienced clinically meaningful improvement in symptoms of congestion, but the response was significantly higher in the combination group than in the budesonide group (83% vs 36%). In addition, significantly more individuals in the combination group experienced a clinically meaningful reduction in Nasal Obstruction Symptom Evaluation scores (≥ 20) at 4 weeks (76% vs 46%). No differences in 22-Item Sino-Nasal Outcome Test appeared between the groups.

Two participants in each group withdrew from the study because of adverse events. Those in the combination group cited jitters and increased anxiety. One patient in the budesonide group reported insomnia, and the other experienced significant nosebleed.

None of the participants in the combination group developed signs of rebound congestion, and all were successfully weaned off oxymetazoline after the active treatment period.

The effectiveness of oxymetazoline as a decongestant was not unexpected, and Farrell noted that she has used the oxymetazoline/steroid combination in a few patients prior to the study, with good success. The short timeframe was the primary limitation of the current study; data on longer-term use are lacking and would be helpful to increase evidence of safety, she added.

However, despite the small sample size and short timeframe, the results support oxymetazoline combined with budesonide as an option for patients with chronic nasal obstruction who are not able or willing to undergo surgery, Farrell said.

Findings Open Door for Extended Use

The use of oxymetazoline as an effective decongestant is limited to 3-5 days because of the risk for rebound congestion, said Arianne K. Baldomero, MD, MS, a pulmonologist and associate professor of medicine at the University of Minnesota, Minneapolis.

This new study provides insight on whether co-administering an intranasal steroid could prevent tachyphylaxis and rebound, potentially allowing extended use for chronic nasal obstruction, said Baldomero, who was not involved in the study. Previous studies have similarly shown that combining a rapid-acting decongestant with an intranasal steroid yields superior relief compared with steroid monotherapy, although these prior trials were in populations with allergic rhinitis, she noted.

The new results add to the evidence in support of combination treatment and suggest that short- to medium-term combination therapy with oxymetazoline and an intranasal steroid may offer a viable therapeutic option for patients with severe, recalcitrant nasal obstruction who have failed intranasal steroids alone, said Baldomero. More research is needed not only to assess long-term safety beyond 4 weeks but also to evaluate potential late-onset rebound risk and test efficacy across broader patient populations, she added.

The study was supported in part by the National Institute on Deafness and Other Communication Disorders, part of the National Institutes of Health, through the Otolaryngology R25 Mentored Research Pathway for Residents and Medical Students training grant. Disclosure information for study authors is available in the original study publication. The cited authors had no conflicts of interest. Baldomero had no financial conflicts to disclose.