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  • Title: Safety, tolerability, and plasma exposure of tiotropium Respimat® in children and adults with cystic fibrosis.
    Author: Konstan MW, Sharma A, Moroni-Zentgraf P, Wang F, Koker P.
    Journal: J Aerosol Med Pulm Drug Deliv; 2015 Apr; 28(2):137-44. PubMed ID: 25380193.
    Abstract:
    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® Soft Mist™ Inhaler in patients with CF. METHODS: Patients received a single dose (placebo, 2.5 μg, 5 μg, or 10 μg) and/or multiple doses (placebo, 2.5 μg, or 5 μg) 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 μg or 5 μg inhaled via the Respimat® Soft Mist™ Inhaler once daily was well tolerated in patients with CF.
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