my personal edition > otorhino. other > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Nasal Clearance Somewhat Faster With Preservative-Free Intranasal Steroid: Presented at AAO-HNSF

By Paula Moyer
Special to DG News

SAN DIEGO, CA -- September 25, 2002 -- Nasal clearance is faster with a preservative-free intranasal corticosteroid than with an intranasal corticosteroid that contains the preservative benzalkonium chloride, according to Dr. Robert M. Naclerio.

He and colleagues were concerned because previous in vitro studies had shown that benzalkonium chloride may have adverse effects on cilia, said Dr. Naclerio, professor and chief of otolaryngology-head and neck surgery at the University of Chicago. Additionally, there have been some reports that the preservative is associated with adverse effects in people with asthma who use corticosteroid inhalers.

In research reported here at the 106th annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation, he and colleagues followed 20 subjects who had allergic rhinitis in an open-label, randomised trial comparison of budesonide (Rhinocort Aqua), which is preservative-free, and mometasone (Nasonex), which contains benzalkonium chloride. AstraZeneca, the manufacturer of Rhinocort, funded the study.

The subjects underwent two weeks of treatment. Before and after the two-week treatment period, they completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). The investigators measured nasal clearance with radioactive particles that were in the steroid formulations. Nasal clearance is an indirect way of assessing mucociliary transport, Dr. Naclerio said.

After the treatment period, subjects' response to the questionnaire showed beneficial effects for both treatments. Nasal clearance rates, which were the same at baseline, were significantly better for budesonide (p=0.04), he said. He and his co-investigators advocate a larger study, in order to find out if this small significant difference would expand into a meaningful clinical difference with a larger database.

"Intranasal steroids are a very popular, effective treatment for allergic rhinitis," Dr. Naclerio said. For years, there have been in vitro studies that suggested that benzalkonium chloride has adverse effects on the cilia. Some earlier studies showed that people who use a preservative-free formulation didn't experience rebound as quickly after treatment was discontinued. So we wanted to study steroid preparations with and without the preservative. By using a radioactive detection system, our method was more sensitive than previous studies with human subjects."

One unanswered question is the extent to which allergic rhinitis itself affects the nasal clearance of an intranasal steroid, he said. "The next step is to understand the effect of the disease and compare the two formulations in normal controls," he said, noting that several other questions remain.

"What is the preservative doing? It's killing bacteria and fungi that could contaminate the product," he said. "Is the preservative-free formulation as good at keeping the sterility of the solution? If it isn't as good, is this side effect worth making a big deal about? It would take large clinical trials to show that this change was anything meaningful."

E-Mail this DGDispatch to a colleague

To print, use this version