P260 Tiotropium Respimat® Add-on To Inhaled Corticosteroids Improves Lung Function In Patients With Symptomatic Mild Asthma: Results From A Phase Iii Trial. (10th November 2014)

• Record Type: Journal Article
• Authors: Paggiaro, P; Halpin, DMG; Buhl, R; Engel, M; Zubek, VB; Blahova, Z; Moroni-Zentgraf, P; Pizzichini, E
• Is Part Of: Thorax. Volume 69(2014)Supplement 2
• Page Start: A191
• Page End: A191
• Publication Date: 2014-11-10
• Subjects: Chest -- Diseases -- Periodicals; Thorax; Chest -- Diseases; Periodicals; Periodicals; 617.54
• DOI: 10.1136/thoraxjnl-2014-206260.388
• Languages: English
• ISSNs: 0040-6376

Abstract

Abstract : 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 (FEV1 ) within 3 h of dosing (0–3h) response (change from baseline) at 12 weeks. Secondary end points were trough FEV1, FEV1 area under the curve (AUC)(0–3h) and peak expiratory flow responses (measured with the AM2+ ® device), and seven-question Asthma Control Questionnaire (ACQ-7) score. Results: Of 464 treated patients, 155 received tiotropium Respimat ® 5 µg, 154 received tiotropium Respimat ® 2.5 µg and 155 received placebo Respimat ® . Both tiotropium Respimat ® doses were superior to placebo Respimat ® in peak FEV1(0–3h) response (adjusted mean difference: 5 µg, 128 mL; 2.5 µg, 159 mL; both p < 0.001) and trough FEV1 response (adjusted mean difference: 5 µg, 122 mL, p = 0.001; 2.5 µg, 110 mL, p = 0.003). FEV1 AUC(0–3h) response at each visit, versus placebo Respimat ®, significantly favoured tiotropium Respimat ® 5 µg (p = 0.009 to p < 0.001) and 2.5 µg (all p < 0.001, except Day 1). Adjusted mean morning and evening peak expiratory flow responses, versus placebo Respimat ®, each week, all favoured tiotropium Respimat ® 5 µg (all p < 0.001) and 2.5 µg (all p < 0.003). Adjusted mean ACQ­-7 score was similar across all arms (tiotropium Respimat ® 5 µg, 1.391; tiotropium Respimat ® 2.5 µg, 1.438; placebo Respimat ®, 1.377). Adverse events were predominantly mild or moderate and were balanced between treatment groups. Conclusion: Tiotropium Respimat ® was effective and well tolerated in patients with symptomatic mild asthma despite low-dose inhaled corticosteroid treatment.