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A randomized study of tiotropium Respimat Soft Mist inhaler vs. ipratropium pMDI in COPD.
Respir Med. 2008 Jan; 102(1):32-41.RM

Abstract

The aim of these studies was to compare the efficacy and the safety of tiotropium, delivered via Respimat Soft Mist Inhaler (SMI), a novel multi-dose, propellant-free inhaler, with ipratropium pressurized metered-dose inhaler (pMDI) in chronic obstructive pulmonary disease (COPD) patients. Two identical, 12-week, multi-national, randomized, double-blind, double-dummy, parallel-group, active- and placebo-controlled studies were performed. COPD patients were randomized to treatment with either inhaled tiotropium (5 or 10 microg) via Respimat SMI administered once daily, ipratropium (36 microg) pMDI QID or placebo. The primary endpoint was the mean trough forced expiratory volume in 1s (FEV(1)) response after 12 weeks of treatment. Secondary endpoints included other spirometry measures and rescue medication use. A total of 719 patients were randomized; the majority were male (69%) with a mean pre-bronchodilator FEV(1) (% predicted) of 40.7%. The mean treatment differences between tiotropium 5 and 10 microg and placebo for the primary endpoint (mean trough FEV(1) response at week 12) were 0.118 and 0.149L, respectively (both P<0.0001). Treatment differences between tiotropium 5 and 10 microg and ipratropium were 0.064L (P=0.006) and 0.095L (P<0.0001). The increases in peak FEV(1), FEV(1) AUC((0-6h)) and FVC for both tiotropium doses were statistically superior to placebo (P<0.01) and higher than ipratropium. All active treatments significantly reduced the rescue medication use compared with placebo, but only tiotropium 10 microg was statistically superior to ipratropium (P=0.04). The incidence of adverse events was comparable across groups. In conclusion, tiotropium 5 and 10 microg daily, delivered via Respimat SMI, significantly improved lung function compared with ipratropium pMDI and placebo.

Authors+Show Affiliations

Medizinische Klinik III, Stiftung Krankenhaus Bethanien für die, Grafschaft Moers, Bethanienstr. 21, D-47441 Moers, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17996436

Citation

Voshaar, T, et al. "A Randomized Study of Tiotropium Respimat Soft Mist Inhaler Vs. Ipratropium pMDI in COPD." Respiratory Medicine, vol. 102, no. 1, 2008, pp. 32-41.
Voshaar T, Lapidus R, Maleki-Yazdi R, et al. A randomized study of tiotropium Respimat Soft Mist inhaler vs. ipratropium pMDI in COPD. Respir Med. 2008;102(1):32-41.
Voshaar, T., Lapidus, R., Maleki-Yazdi, R., Timmer, W., Rubin, E., Lowe, L., & Bateman, E. (2008). A randomized study of tiotropium Respimat Soft Mist inhaler vs. ipratropium pMDI in COPD. Respiratory Medicine, 102(1), 32-41.
Voshaar T, et al. A Randomized Study of Tiotropium Respimat Soft Mist Inhaler Vs. Ipratropium pMDI in COPD. Respir Med. 2008;102(1):32-41. PubMed PMID: 17996436.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized study of tiotropium Respimat Soft Mist inhaler vs. ipratropium pMDI in COPD. AU - Voshaar,T, AU - Lapidus,R, AU - Maleki-Yazdi,R, AU - Timmer,W, AU - Rubin,E, AU - Lowe,L, AU - Bateman,E, Y1 - 2007/11/08/ PY - 2007/03/30/received PY - 2007/08/16/revised PY - 2007/08/23/accepted PY - 2007/11/13/pubmed PY - 2008/8/15/medline PY - 2007/11/13/entrez SP - 32 EP - 41 JF - Respiratory medicine JO - Respir Med VL - 102 IS - 1 N2 - The aim of these studies was to compare the efficacy and the safety of tiotropium, delivered via Respimat Soft Mist Inhaler (SMI), a novel multi-dose, propellant-free inhaler, with ipratropium pressurized metered-dose inhaler (pMDI) in chronic obstructive pulmonary disease (COPD) patients. Two identical, 12-week, multi-national, randomized, double-blind, double-dummy, parallel-group, active- and placebo-controlled studies were performed. COPD patients were randomized to treatment with either inhaled tiotropium (5 or 10 microg) via Respimat SMI administered once daily, ipratropium (36 microg) pMDI QID or placebo. The primary endpoint was the mean trough forced expiratory volume in 1s (FEV(1)) response after 12 weeks of treatment. Secondary endpoints included other spirometry measures and rescue medication use. A total of 719 patients were randomized; the majority were male (69%) with a mean pre-bronchodilator FEV(1) (% predicted) of 40.7%. The mean treatment differences between tiotropium 5 and 10 microg and placebo for the primary endpoint (mean trough FEV(1) response at week 12) were 0.118 and 0.149L, respectively (both P<0.0001). Treatment differences between tiotropium 5 and 10 microg and ipratropium were 0.064L (P=0.006) and 0.095L (P<0.0001). The increases in peak FEV(1), FEV(1) AUC((0-6h)) and FVC for both tiotropium doses were statistically superior to placebo (P<0.01) and higher than ipratropium. All active treatments significantly reduced the rescue medication use compared with placebo, but only tiotropium 10 microg was statistically superior to ipratropium (P=0.04). The incidence of adverse events was comparable across groups. In conclusion, tiotropium 5 and 10 microg daily, delivered via Respimat SMI, significantly improved lung function compared with ipratropium pMDI and placebo. SN - 0954-6111 UR - https://www.unboundmedicine.com/medline/citation/17996436/A_randomized_study_of_tiotropium_Respimat_Soft_Mist_inhaler_vs__ipratropium_pMDI_in_COPD_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0954-6111(07)00364-2 DB - PRIME DP - Unbound Medicine ER -