期刊
JOURNAL OF AEROSOL MEDICINE AND PULMONARY DRUG DELIVERY
卷 28, 期 2, 页码 137-144出版社
MARY ANN LIEBERT, INC
DOI: 10.1089/jamp.2013.1115
关键词
spirometry; cystic fibrosis; Respimat((R)); tiotropium bromide; SPIRIVA((R)); lung function
资金
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Boehringer Ingelheim
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.
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