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Am. J. Respir. Crit. Care Med., Volume 161, Number 4, April 2000, 1136-1142

Long-Acting Bronchodilation with Once-Daily Dosing of Tiotropium (Spiriva) in Stable Chronic Obstructive Pulmonary Disease

MICHAEL R. LITTNER, JONATHAN S. ILOWITE, DONALD P. TASHKIN, MITCHELL FRIEDMAN, CHARLES W. SERBY, SHAILENDRA S. MENJOGE, and THEODORE J. WITEK Jr.

Sepulveda Ambulatory Care and Nursing Home, Veterans Administration Greater Los Angeles Healthcare System, Sepulveda; UCLA School of Medicine, Pulmonary Division, Los Angeles, California; Pulmonary Division, Winthrop University Hospital, Mineola, New York; Section of Pulmonary Disease, Critical Care and Environmental Medicine, Tulane University Medical Center, New Orleans, Louisiana; and Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut

Tiotropium (Spiriva; Ba679BR) is a new-generation, long-acting anticholinergic bronchodilator that has muscarinic M1 and M3 receptor subtype selectivity. A multicenter, randomized, double-blind, parallel group, placebo-controlled study was conducted to evaluate the dose-response characteristics of tiotropium inhalation powder given once daily to stable patients with chronic obstructive pulmonary disease (COPD). Patients (mean FEV1 = 1.08 L [42% predicted]) were randomized to receive 0, 4.5, 9, 18, or 36 µg tiotropium once daily at noon for 4 wk, with spirometry done before and hourly for 6 h after dosing. Patients measured and recorded their peak expiratory flow rates (PEFRs) three times each day. Significant dose-related improvement in FEV1 and significant improvement in FVC occurred within 1 h after the first dose of tiotropium as compared with placebo. Over the 29 d of the study, all doses of tiotropium produced significant increases over placebo in trough (i.e., as measured spirometrically at 20 to 24 h after the previous dose and just before the next dose of tiotropium), peak, and 6-h postdose average FEV1 and FVC, and in PEFR, without a significant difference among the different doses investigated. PEFR gradually returned to pretreatment baseline levels over a 3-wk evaluation period following the discontinuation of tiotropium. The overall safety profile for the tiotropium doses was similar to that for placebo. In summary, tiotropium was shown to be safe and effective in doses ranging from 4.5 to 36 µg delivered once daily. The improvements in spirometry with once-daily dosing confirm the long duration of action of tiotropium reported in single-dose studies, and its sustained improvement of spirometric measures over the 1 mo of testing in the study points to utility of tiotropium as a maintenance bronchodilator for patients with COPD. On the basis of the comparable bronchodilator response at doses from 9 to 36 µg, and advantages suggested by the safety profile at doses below 36 µg in this study, a dose of 18 µg once daily was selected for use in long-term studies of the safety and efficacy of tiotropium.




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