Chronic Sinusitis Treatment with Aerosolized Antibiotics Found Effective

A team of otolaryngologist--head and neck surgeons at Stanford University Medical Center have tested nebulization (aerosolization) as an alternative method of delivering antibiotics for chronic sinusitis. They believe this method is less invasive and effectively treats severe sinus infections. Chronic sinusitis affects 37 million Americans.

Traditionally, antibiotics for chronic sinusitis patients have been administered orally or intravenously. A nebulizer is a machine that aerates medication which is then inhaled through the mouth or nose.

Nebulized antibiotic administration for chronic sinusitis is not new. It has also been used in Japan for many years. However, this method of antibiotic administration for chronic sinusitis has not yet been widely tested in the United States.

When chronic sinusitis does not respond to repeated antibiotic therapy, functional endoscopic sinus surgery (FESS) is often performed to clear the sinus cavities and remove blockages. In some cases, this surgery may need to be repeated before relief is achieved. When antibiotic therapy is effective, the need for repeated surgeries may be eliminated.

A new pilot study has now demonstrated that when offered a choice, patients with chronic sinusitis who have had FESS and continue to have infections, prefer nebulized antibiotics in lieu of oral or intravenous medical treatment. The findings also revealed that this form of drug administration provided a longer infection-free period, up from six weeks to 17 weeks.

This study, "Use of Nebulized Antibiotics for Acute Infections in Chronic Sinusitis," is authored by Winston C. Vaughan, MD, and Gerard Carvalho, MD, both from the Division of Otolaryngology -- Head and Neck Surgery at Stanford University, and is published in the December issue of Otolaryngology -- Head and Neck Surgery (http://www.mosby.com). Their findings advocate vaporized administration of antibiotics as a safe and effective alternative to oral and intravenous antibiotic therapy for chronic sinus patients with acute infections that continue after surgery.

METHODOLOGY: Over a 12 month period, 42 patients (28 female and 14 males, average age of 45.2) were enrolled in the study. Inclusion criteria included a diagnosis of chronic sinusitis of over six months, previous FESS, over 21 years of age, acute sinus infection with visible purulence (pus), and no antibiotic usage within previous two weeks.

Sinus drainage of each patient was cultured with sensitivities and gram stain results. A three-week supply of culture-directed antibiotics was prescribed. For all subjects the antibiotics were compounded and dispensed at SinusPharmacy, Inc. in Santa Barbara, CA, for use in a nebulizer, which produced a mist with an average particle size of 3.2 microns.

Patients were examined every one to two weeks while undergoing nebulization and for a minimum of three months thereafter. The examination included: history and physical, otoscopy, nasal endoscopy, Rhinosinusitis Outcome Measure 31 questionnaire (RSOM-31), and cultures of any visible purulence at the end of the three week antibiotic therapy.

Patients were given only FDA-approved, culture-directed antibiotics through nebulization and were encouraged to continue their previous medications, which may have included nasal sprays, leukotriene inhibitors, antihistamines, oral steroids, and pulmonary inhalers. Antibiotics nebulized for this study include: levofloxacin, ofloxacin, ciprofloxacin, tobramycin, ceftazidime, and gentamicin.

Data was obtained by retrospective chart review.

RESULTS: There were a total of 50 treatments in 42 patients with six patients having more than one treatment within the 12 month study period. Four patients had two treatments each, and two patients had three treatments each. All patients receiving repeat treatments chose repeated nebulization versus oral or intravenous antibiotic options.

A total of nine patients experienced varying minor side effects including: sore throat (four patients), cough (three asthmatic patients), tinnitus (one patient with middle ear fluid), and joint pain (one patient). All side effects resolved three to 14 days post-therapy.

Two treatments were stopped before the end of therapy. Thirty-eight of the 42 patients were considered successfully treated with nebulized antibiotics. NOTE: Of the successfully treated group, 28 patients were clear of infection at the three month follow-up, and 10 were infected with a different organism than the one previously treated.

Six patients were reinfected with the same organism. Five patients had continuous infections, and one patient had revision FESS. These patients accounted for a 12 percent failure rate.

The self-reporting RSOM-31 questionnaire revealed statistically significant improvements in posterior nasal discharge, thick nasal debris, facial pressure, pain, and emotional consequences related to sinus infections.

CONCLUSIONS: Successful outcomes were seen in 76-88 percent of patients. Patients found the treatment easy to use and experienced few mild side effects. Several of the more chronic patients now select culture-directed nebulized antibiotics when they experience an acute infection.

These findings demonstrate that nebulized antibiotic therapy is a safe and effective alternative for treatment of acute sinus infection in chronic sinusitis patients who have previously undergone functional endoscopic sinus surgery. These results indicate a need for further research involving a large patient population in a multi-center clinical trial.