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DURHAM, N.C. -- A new Duke University Medical Center study
shows that patients with sinus infections recover faster and
manifest symptoms for a shorter period of time when using
fluticasone, a steroid nasal spray, in addition to treatment
with antibiotics and decongestants.

Researchers believe these results indicate that steroid
nasal sprays should be part of a recommended treatment regimen
for patients with recurrent episodes of acute rhinosinusitis or
chronic sinusitis. The study is in the Dec. 26, 2001, issue of
the Journal
of the American Medical Association.

In the United States, patients make 25 million visits
annually for sinusitis symptoms. Nasal sprays containing
corticosteriods such as fluticasone propionate are used
primarily to control symptoms of allergies and post-nasal drip
by reducing inflammation and swelling in the sinuses. The Duke
researchers, led by Dr. Rowena Dolor, believed that these same
nasal sprays, called intranasal corticosteriods, when combined
with antibiotics, might speed the recovery time in patients
with acute sinus infections.

"Because recurrent and chronic sinus disease is more
difficult to treat, our goal was to examine the benefits of
adding an intranasal corticosteroid to standard antibiotic
therapy," Dolor said.

For the study, 95 adults with a history of recurrent or
chronic sinusitis and evidence of an acute infection were
recruited from October 1998 through April 2000 at 12 primary
care and 10 otolaryngology community-based clinics nationwide.
The study was a double-blind, randomized, placebo-controlled
trial.

Participants were confirmed to have sinusitis by X-ray or
endoscopic examination. Forty-seven patients were given two
puffs of fluticasone in each nostril for 21 days, and 48 were
given two puffs of a placebo nasal spray for the same period of
time. All participants were given two puffs of the decongestant
xylometazoline hydrochloride twice daily for three days and the
antibiotic cefuroxime axetil twice daily for 10 days. Patients
recorded in a diary their daily symptom status and were
contacted by telephone at 10, 21 and 56 days to record any
adverse effects or treatment failures.

A total of 88 patients completed the three-week treatment
and follow-up. Ninety-three percent of patients receiving
fluticasone reported a cure or significant improvement of sinus
problems, compared to only 74 percent receiving placebo.
Patients on fluticasone also had their symptoms improve an
average of three days faster than patients receiving placebo.
Dolor believes that the more rapid improvement is key because
it is associated with greater productivity in working
populations.

There were no serious adverse effects reported; however,
there was a trend toward more mild adverse events in the
fluticasone group.

One limitation of the study was that providers based the
diagnosis of sinusitis on clinical symptoms and either sinus
radiograph or endoscopy, but did not collect samples to analyze
whether the infection was bacterial or viral. Dolor said this
mirrors diagnostic approaches in usual clinical practice.

Dolor believes this research is compelling enough to
recommend that expert panels developing evidence-based
treatment guidelines for acute rhinosinusitis include
intranasal corticosteriods as part of the therapeutic regimen
for patients presenting with recurrent or chronic symptoms.

GlaxoSmithKline, maker of fluticasone (Flonase®) and
cefuroxime (Ceftin®), funded and supplied the medication for
the study.