This is very encouraging news for the CF community and represents a significant response to our concerns. The Foundation also appreciates the work done by Dr. John LiPuma, director of the CF Foundation-supported B. cepacia Repository at St. Christopher's Hospital in Philadelphia. The data that have been accumulated by the repository were instrumental in educating the EPA about the nature of this problem. In both groups, patients were also allowed to receive standard treatment recommended for the management of cystic fibrosis, which may have included oral or intravenous antibiotics. TOBI has shown us that inhaled antibiotics work, and that has tremendous implications for future treatment of cystic fibrosis.
Pulmonary function is the best predictor of disease progression in people with cystic fibrosis.
TOBI patients also were 36 percent less likely to require intravenous antipseudomonal antibiotics than patients taking placebo. Overall adverse events were comparable but less severe in the TOBI group than in the placebo group. It was transient and appeared mild or moderate in severity. Four patients in the placebo group and none in the TOBI group died during the studies. Many of these patients are able to achieve things they've never been able to achieve before.