Safety, Tolerability, and Plasma Exposure of Tiotropium Respimat((R)) in Children and Adults with Cystic Fibrosis

Background: People with cystic fibrosis (CF) suffer from chronic lung disease that is often treated with a bronchodilator. This trial evaluated the pharmacokinetics, safety, and tolerability of single and multiple doses of tiotropium inhaled via the Respimat((R)) Soft Mist (TM) Inhaler in patients with CF. Methods: Patients received a single dose (placebo, 2.5 mu g, 5 mu g, or 10 mu g) and/or multiple doses (placebo, 2.5 mu g, or 5 mu g) of tiotropium daily for 28 days. Results: Ninety-two patients, aged 5-57 years, were treated. All doses showed a satisfactory safety profile for adverse events, vital signs, laboratory evaluations, and physical examination. At steady-state, peak exposure to tiotropium was comparable between adult patients with CF and patients with chronic obstructive pulmonary disease. Conclusions: Tiotropium 2.5 mu g or 5 mu g inhaled via the Respimat((R)) Soft Mist (TM) Inhaler once daily was well tolerated in patients with CF.