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RESEARCH PRODUCT

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

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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 (change from baseline) at 12 weeks. Secondary end points were trough FEV 1 , FEV 1 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 FEV 1(0–3h) response (adjusted mean difference: 5 µg, 128 mL; 2.5 µg, 159 mL; both p 1 response (adjusted mean difference: 5 µg, 122 mL, p = 0.001; 2.5 µg, 110 mL, p = 0.003). FEV 1 AUC (0–3h) response at each visit, versus placebo Respimat ® , significantly favoured tiotropium Respimat ® 5 µg (p = 0.009 to p ® , each week, all favoured tiotropium Respimat ® 5 µg (all p ® 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.