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P260 Tiotropium Respimat® Add-on To Inhaled Corticosteroids Improves Lung Function In Patients With Symptomatic Mild Asthma: Results From A Phase Iii Trial
  1. P Paggiaro1,
  2. DMG Halpin2,
  3. R Buhl3,
  4. M Engel4,
  5. VB Zubek5,
  6. Z Blahova6,
  7. P Moroni-Zentgraf4,
  8. E Pizzichini7
  1. 1University of Pisa, Pisa, Italy
  2. 2Royal Devon and Exeter Hospital, Exeter, UK
  3. 3Mainz University Hospital, Mainz, Germany
  4. 4Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim Am Rhein, Germany
  5. 5Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, USA
  6. 6Boehringer Ingelheim RCV GmbH and Co. KG, Vienna, Austria
  7. 7NUPAIVA (Asthma Research Centre), Universidade Federal de Santa Catarina, Florianópolis, Santa Catarina, Brazil

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.

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