12/23/02 News Release

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STANFORD, Calif. ­ Three years ago, Joanne Clark was so miserable from recurring sinus infections and the antibiotics used to treat them that she felt ready to give up. Despite three surgeries, Clark, a resident of Lodi, Calif., continued getting sinus infections every two to four weeks. The painful headaches and feelings of exhaustion, not to mention the severe nausea from oral antibiotics, forced her to quit her job as a physical education teacher. “I felt horrible,” she said. “I had headaches all the time. I had no energy. I didn’t want to live a life like this.”

Clark eventually came to Stanford University Medical Center where Winston Vaughan, MD, an otolaryngologist, sinus surgeon and director of the Stanford Sinus Center, suggested she participate in a clinical trial of an innovative new treatment. Instead of taking antibiotics in a pill, Clark could breathe them into her sinuses using a nebulizer – a machine that converts medication from a liquid into an inhalable mist.

Conducted over 12 months beginning in November 2000, the study is the first to prospectively evaluate the effectiveness of nebulized antibiotics for the treatment of chronic sinusitis following surgery. Results have been published in the December issue of Otolaryngology, Head and Neck Surgery.

After taking the nebulized antibiotics twice daily for three weeks, Clark experienced significant relief. Her symptoms including headaches, congestion and fatigue subsided more quickly than with antibiotic pills, and she remained infection-free far longer – nearly three months. While she experienced some mild side effects, “it was nothing compared with the pills.” Most of the other study participants saw similar benefits from nebulized antibiotics. Of the 42 patients studied – all adults who suffered recurrent sinus infections after surgery – 76 percent reported “significant improvement” in symptoms, confirmed through physical exams and sinus endoscopies.

Significantly, the patients who benefited from the treatment remained free of infection for an average of 17 weeks, compared with six weeks previously. Like Clark, they reported few side effects and improved quality of life.

Based on these results, Vaughan believes nebulized antibiotics represent a promising alternative for patients who continue getting sinus infections even after surgery and who have failed, or cannot tolerate, oral or intravenous antibiotics. “These results are very encouraging,” said Vaughan, assistant professor of surgery at the School of Medicine and lead author of the study. Nebulized antibiotics “may serve as a new treatment option in an often frustrating disease process.”

Sinusitis affects 35 million Americans, making it the country’s most prevalent chronic condition, according to the Centers for Disease Control and Prevention. As Clark’s experience shows, the condition can significantly reduce productivity and quality of life.

“These patients feel miserable,” Vaughan said. “They have facial pain, they can’t breathe and they can’t sleep.” Nebulized antibiotics, he said, were developed in the late 1990s “out of a desperate need for something else.”

While asthma patients have long relied upon nebulizers to inhale medication into their lungs, the use of nebulized antibiotics to treat sinus infections has emerged only in the last two to three years.
Why does the treatment work so well? “The common-sense answer is, we’re getting more of the medication directly to the tissues that need it,” Vaughan explained, since the medication is inhaled into the nostrils instead of circulating through the entire body. He said more research is needed to understand exactly how the treatment works.

Vaughan chairs the scientific advisory board of SinusPharmacy Corp., a company that formulates nebulized antibiotics and other medications to treat sinus infections. The company’s medications were used in the Stanford study. All data from the study was analyzed independently of the company. The research was funded solely by Stanford University Medical Center.

Clark, for her part, still gets sinus infections three to four times a year, but she said the episodes are far more manageable with nebulized antibiotics. Thanks to her improved health, she has returned to work at her school district.

“I feel great most of the time,” Clark said. “I tell people this treatment gave me my life back.”

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