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Long-acting bronchodilation with once-daily dosing of tiotropium (Spiriva) in stable chronic obstructive pulmonary disease.
Am J Respir Crit Care Med. 2000 Apr; 161(4 Pt 1):1136-42.AJ

Abstract

Tiotropium (Spiriva; Ba679BR) is a new-generation, long-acting anticholinergic bronchodilator that has muscarinic M(1) and M(3) 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 FEV(1) = 1.08 L [42% predicted]) were randomized to receive 0, 4.5, 9, 18, or 36 microg 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 FEV(1) 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 FEV(1) 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 microg 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 microg, and advantages suggested by the safety profile at doses below 36 microg in this study, a dose of 18 microg once daily was selected for use in long-term studies of the safety and efficacy of tiotropium.

Authors+Show Affiliations

Sepulveda Ambulatory Care and Nursing Home, Veterans Administration Greater Los Angeles Healthcare System, Sepulveda, CA, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10764302

Citation

Littner, M R., et al. "Long-acting Bronchodilation With Once-daily Dosing of Tiotropium (Spiriva) in Stable Chronic Obstructive Pulmonary Disease." American Journal of Respiratory and Critical Care Medicine, vol. 161, no. 4 Pt 1, 2000, pp. 1136-42.
Littner MR, Ilowite JS, Tashkin DP, et al. Long-acting bronchodilation with once-daily dosing of tiotropium (Spiriva) in stable chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000;161(4 Pt 1):1136-42.
Littner, M. R., Ilowite, J. S., Tashkin, D. P., Friedman, M., Serby, C. W., Menjoge, S. S., & Witek, T. J. (2000). Long-acting bronchodilation with once-daily dosing of tiotropium (Spiriva) in stable chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine, 161(4 Pt 1), 1136-42.
Littner MR, et al. Long-acting Bronchodilation With Once-daily Dosing of Tiotropium (Spiriva) in Stable Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2000;161(4 Pt 1):1136-42. PubMed PMID: 10764302.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-acting bronchodilation with once-daily dosing of tiotropium (Spiriva) in stable chronic obstructive pulmonary disease. AU - Littner,M R, AU - Ilowite,J S, AU - Tashkin,D P, AU - Friedman,M, AU - Serby,C W, AU - Menjoge,S S, AU - Witek,T J,Jr PY - 2000/4/14/pubmed PY - 2000/6/10/medline PY - 2000/4/14/entrez SP - 1136 EP - 42 JF - American journal of respiratory and critical care medicine JO - Am. J. Respir. Crit. Care Med. VL - 161 IS - 4 Pt 1 N2 - Tiotropium (Spiriva; Ba679BR) is a new-generation, long-acting anticholinergic bronchodilator that has muscarinic M(1) and M(3) 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 FEV(1) = 1.08 L [42% predicted]) were randomized to receive 0, 4.5, 9, 18, or 36 microg 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 FEV(1) 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 FEV(1) 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 microg 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 microg, and advantages suggested by the safety profile at doses below 36 microg in this study, a dose of 18 microg once daily was selected for use in long-term studies of the safety and efficacy of tiotropium. SN - 1073-449X UR - https://www.unboundmedicine.com/medline/citation/10764302/Long_acting_bronchodilation_with_once_daily_dosing_of_tiotropium__Spiriva__in_stable_chronic_obstructive_pulmonary_disease_ L2 - http://www.atsjournals.org/doi/full/10.1164/ajrccm.161.4.9903044?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -