Oral cyclosporine was effective in the DEBR model for alopecia areata. All rats had a full pelage by 5 weeks of treatment with 10 mg/kg/d, 5 d/wk for 7 weeks. Studies in humans also have proven efficacy with doses of 6 mg/kg/d for 3 months in 6 patients. All patients experienced regrowth, and cosmetically acceptable regrowth was seen in 3 of 6 patients. Unfortunately, all patients relapsed within 3 months of discontinuation of cyclosporine. No evidence indicates that CsA can prevent hair loss during an active episode because reports have described patients taking CsA who developed alopecia areata while they were under treatment for unrelated conditions.
Cayston (aztreonam for inhalation solution) has been approved by the FDA to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa . The FDA approval of Cayston was based on a randomized, double-blind, placebo-controlled, multi-center trial in 164 subjects. Subjects received either Cayston (75 mg) or volume-matched placebo administered by inhalation 3 times a day for 28 days. Patients were required to have been off antibiotics for at least 28 days before treatment with study drug. The primary efficacy endpoint was improvement in respiratory symptoms on the last day of treatment with Cayston or placebo. Statistically significant improvements were seen in both adult and pediatric patients, but were substantially smaller in adult patients. The treatment difference at 28 days between Cayston-treated and placebo-treated patients for percent change in forced expiratory volume in 1 second (FEV1) was statistically significant at 10 %. Improvements in FEV1 were comparable between adult and pediatric patients. Two weeks after completion of drug treatment, the difference in FEV1 between Cayston and placebo groups had decreased to 6 %.