Tiotropium Respimat® Add-On To Inhaled Corticosteroids Improves Lung Function In Patients With Symptomatic Mild Asthma: Results From A Phase III Trial

The Effect of Tiotropium in Symptomatic Asthma Despite Low- to Medium-Dose Inhaled Corticosteroids: A Randomized Controlled Trial.

BackgroundTiotropium, a once-daily long-acting anticholinergic bronchodilator, has demonstrated efficacy in patients with asthma who were symptomatic despite treatment with medium- to high-dose inhaled corticosteroids (ICS).ObjectiveThe objective of this study was to evaluate the efficacy and safety of once-daily tiotropium Respimat (5 μg or 2.5 μg), compared with placebo Respimat, as add-on therapy to low- to medium-dose ICS for adults with symptomatic asthma.MethodsA phase III, double-blind, placebo-controlled trial was conducted (NCT01316380). Adults with symptomatic asthma receiving low- to medium-dose ICS (200-400 μg budesonide or equivalent dose) and a pre-bronchodilator forced expira…

P260 Tiotropium Respimat(R) Add-on To Inhaled Corticosteroids Improves Lung Function In Patients With Symptomatic Mild Asthma: Results From A Phase Iii Trial

Background Despite currently available therapies and detailed guidelines, many people with mild asthma remain symptomatic; it is important to establish the efficacy and safety of new treatments in this group. Methods A Phase III, randomised, double-blind, parallel-group trial (GraziaTinA-asthma ® ; NCT01316380) evaluated the efficacy and safety of once-daily tiotropium 5 µg or 2.5 µg versus placebo (all delivered via the Respimat ® SoftMist™ inhaler) for 12 weeks in patients with symptomatic asthma on low-dose inhaled corticosteroids (200–400 µg budesonide or equivalent). The primary end point was peak forced expiratory volume in 1 second (FEV 1 ) within 3 h of dosing (0–3h) response (chang…

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

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)…

Tiotropium reduces airflow obstruction in asthma patients, independent of body mass index

P149 Once-daily tiotropium Respimat® add-on to at least ICS in adult patients with symptomatic asthma: pooled safety analysis: Abstract P149 Table 1

Background A high proportion of patients with asthma are symptomatic despite at least ICS maintenance therapy. Five trials aimed to evaluate the safety of tiotropium Respimat® compared with placebo Respimat®, each as add-on to at least ICS in adult patients with symptomatic asthma. Methods Five Phase III and one Phase II randomised, double-blind, placebo-controlled, parallel-group trials. PrimoTinA-asthma® (48 weeks): tiotropium Respimat® 5 µg add-on to ICS + LABA (≥800 µg budesonide or equivalent); MezzoTinA-asthma® (24 weeks): tiotropium Respimat® 5 µg or 2.5 µg add-on to ICS (400–800 µg budesonide or equivalent); GraziaTinA-asthma® (12 weeks): tiotropium Respimat® 5 µg or 2.5 µg add-on t…

Tiotropium Respimat® in asthma: a double-blind, randomised, dose-ranging study in adult patients with moderate asthma

Tiotropium, a once-daily long-acting anticholinergic bronchodilator, when administered via Respimat® SoftMist™ inhaler (tiotropium Respimat®) significantly reduces the risk of severe exacerbations and improves lung function in patients with severe persistent asthma that is not fully controlled despite using inhaled corticosteroids (ICS) and long-acting β2-agonists. To further explore the dose–response curve in asthma, we investigated the efficacy and safety of three different doses of tiotropium Respimat® as add-on to ICS in symptomatic patients with moderate persistent asthma. In this randomised, double-blind, placebo-controlled, four-way crossover study, patients were randomised to tiotro…