Once-daily tiotropium Respimat(®) 5 µg is an efficacious 24-h bronchodilator in adults with symptomatic asthma.
Respir Med
; 109(3): 329-38, 2015 Mar.
Article
em En
| MEDLINE
| ID: mdl-25661281
ABSTRACT
INTRODUCTION:
Once-daily tiotropium Respimat(®) 5 µg is an efficacious add-on therapy to inhaled corticosteroids (ICS) with or without long-acting ß2-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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Asma
/
Broncodilatadores
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Volume Expiratório Forçado
/
Brometo de Tiotrópio
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
/
Middle aged
País/Região como assunto:
Europa
Idioma:
En
Revista:
Respir Med
Ano de publicação:
2015
Tipo de documento:
Article