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Respir Med. 2015 Mar;109(3):329-38. doi: 10.1016/j.rmed.2014.12.005. Epub 2014 Dec 27.

Once-daily tiotropium Respimat(®) 5 μg is an efficacious 24-h bronchodilator in adults with symptomatic asthma.

Author information

1
CRS Clinical Research Services Mannheim GmbH, Grenadierstraße 1, 68167 Mannheim, Germany. Electronic address: w.timmer@inamed-cro.com.
2
TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55218 Ingelheim am Rhein, Germany. Electronic address: petra.moroni-zentgraf@boehringer-ingelheim.com.
3
TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55218 Ingelheim am Rhein, Germany. Electronic address: piet.cornelissen@boehringer-ingelheim.com.
4
Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88400 Biberach an der Riss, Germany. Electronic address: anna.unseld@boehringer-ingelheim.com.
5
NUPAIVA (Asthma Research Centre), Universidade Federal de Santa Catarina, Campus Universitário Reitor João David Ferreira Lima - Trindade, 88040-900 Florianópolis, SC, Brazil. Electronic address: pizzichi@matrix.com.br.
6
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Langenbeckstraße 1, 55131 Mainz, Germany. Electronic address: roland.buhl@unimedizin-mainz.de.

Abstract

INTRODUCTION:

Once-daily tiotropium Respimat(®) 5 μg is an efficacious add-on therapy to inhaled corticosteroids (ICS) with or without long-acting β2-agonists in patients with symptomatic asthma. The objective of this study was to investigate whether the dosing regimen of tiotropium (once- versus twice-daily), delivered via the Respimat(®) SoftMist™ inhaler, affected 24-h bronchodilator efficacy and safety versus placebo Respimat(®) in patients with asthma who were symptomatic despite medium-dose ICS therapy.

METHODS:

A randomised, double-blind, placebo-controlled, crossover study with 4-week treatment periods of tiotropium 5 μg (once-daily, evening) and 2.5 μg (twice-daily, morning and evening). The primary efficacy end point was forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 24 h (AUC)(0-24h) at the end of each treatment period. Secondary end points included peak forced expiratory volume in 1 s measured within 24 h of the last evening inhalation (peak FEV1(0-24h)), trough FEV1 measured prior to evening dosing, morning and evening peak expiratory flow (PEFam and PEFpm) and pharmacokinetic assessments.

RESULTS:

94 patients were randomised (mean age 44.3 years; mean asthma duration 21.3 years) and 89 (94.7%) completed the study. Significant and comparable bronchodilation was achieved over a 24-h period with both tiotropium dosing regimens. FEV1 AUC(0-24h) response (mean ± standard error) was significantly greater with both tiotropium dosing regimens (once-daily 5 μg: 158 ± 24 mL; twice-daily 2.5 μg; 149 ± 24 mL; both p < 0.01) when compared with placebo. Improvements in peak FEV1(0-24h), trough FEV1 and pre-dose PEFam/pm with both dosing regimens versus placebo were statistically significant (all p < 0.01), with no statistically significant differences between the tiotropium treatment regimens. Total systemic exposure and tolerability were comparable between treatment regimens.

CONCLUSIONS:

Lung function improvements with tiotropium Respimat(®) add-on to medium-dose ICS were sustained and similar for once-daily 5 μg and twice-daily 2.5 μg, supporting tiotropium Respimat(®) 5 μg as a once-daily bronchodilator that provides efficacy over the whole 24-h dosing interval in patients with symptomatic asthma. ClinicalTrials.gov identifier: NCT01152450.

KEYWORDS:

Anticholinergic drug; Asthma; Bronchodilator efficacy; Dosing regimen; Long-acting bronchodilator; Tiotropium

PMID:
25661281
DOI:
10.1016/j.rmed.2014.12.005
[Indexed for MEDLINE]
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