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RESEARCH PRODUCT

24-h efficacy and pharmacokinetics of tiotropium Respimat® 5 μg in patients with asthma

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Background: Once-daily tiotropium Respimat® (tioR) add-on therapy has demonstrated efficacy in patients with moderate symptomatic asthma. Aim and Objectives: To investigate whether dosing regimen (QD vs BID) affected 24-h bronchodilator efficacy and exposure of tioR. Methods: 2 randomised, double-blind, crossover trials (trial 1, NCT01152450 [placebo-controlled]; trial 2, NCT01696071); 4-week treatments of tioR 5 µg QD, 2.5 µg BID and placebo Respimat® (pboR) added to medium-dose ICS (400-800 µg budesonide or equivalent). Primary end point (Week 4): area under the curve response for FEV1 (FEV1 AUC(0-24h)) (trial 1, tioR vs pboR; trial 2, QD vs BID). Pharmacokinetic end points (steady state) included: AUC(0-τ),ss; AUC(0-24h),ss; cumulative urinary excretion of tiotropium (Ae(0-24h),ss). Results: 192 patients treated overall. Trial 1: both tioR dosing regimens significantly improved lung function vs pboR (FEV1 AUC(0-24h) response [95% CI]: 5 µg QD, 158 mL [111, 205]; 2.5 µg BID, 149 mL [102, 196]; both p Conclusions: Once-daily tiotropium Respimat® 5 µg is an appropriate dosing regimen providing bronchodilation, equivalent to 2.5 µg twice daily, over the 24-h dosing period in patients with symptomatic asthma.