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| |  Inhaled Antibiotic Tobi (Tobramycin) Promising In Treating Bronchiectasis SEATTLE, WA -- August 24, 2000 -- In a study published in the American Journal of Respiratory and Critical Care Medicine, inhaled antibiotic therapy with Tobi® (tobramycin solution for inhalation) has demonstrated promising results in people with bronchiectasis. Tobi was developed by PathoGenesis Corp. and approved in the U.S. for use by cystic fibrosis patients in December 1997. "In this first study of Tobi outside the cystic fibrosis arena, the results are dramatic, promising and warrant further investigation," said Alan F. Barker, M.D., professor of medicine at Oregon Health Sciences University. "Inhaled antibiotics are an appealing alternative to oral or intravenous administration because the antibiotic is delivered in high concentrations directly to the site of infection in the lungs. This eliminates the need for high systemic concentrations and reduces the risk of systemic toxicity." In the Phase II, placebo-controlled, double-blind, randomized study, 300 milligrams of Tobi or an inhaled placebo were administered to 74 bronchiectasis patients with Pseudomonas aeruginosa lung infections. A total of 37 patients inhaled Tobi at home twice a day for four weeks, followed by two weeks off the drug. At the end of the four weeks, bacterial levels in the sputum decreased more than 99.999 percent on average in the Tobi treatment group (a mean decrease of 4.54 log10 colony-forming units per gram of sputum or phlegm), compared to no change on average in the placebo group. At the end of the six weeks, P. aeruginosa was eradicated in 35 percent of the Tobi patients but was detected in all placebo patients. Investigators indicated that 62 percent of the Tobi patients showed an improved medical condition, compared with 38 percent of the placebo patients. Symptoms associated with bronchiectasis and/or inhaled therapy, including cough, shortness of breath, wheezing, and non-cardiac chest pain, were reported by Tobi and placebo patients but did not limit therapy. In June, PathoGenesis began another study of Tobi in patients with severe bronchiectasis to assess the inhaled drug's effect on symptoms, use of other antibiotics and hospitalizations. Bronchiectasis is a chronic, destructive lung disease defined by irreversible, abnormal dilation of the airways' anatomical structure. Earlier episodes of bacterial or viral pneumonia, as well as other factors, can cause this permanent lung damage. Bronchiectasis is characterized by chronic airway infection, which causes cough and sputum production, associated with intermittent exacerbations that may result in periodic hospitalizations. Approximately 70,000 to 100,000 patients have bronchiectasis in the U.S. Most bronchiectasis patients are age 50 or older. Related link: Tobi.
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