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S92 Efficacy Of Once-daily Tiotropium Respimat® 5 µg From Five Phase Iii Trials In Adults With Symptomatic Asthma
  1. D Price1,
  2. ED Bateman2,
  3. P Paggiaro3,
  4. A Kaplan4,
  5. M Engel5,
  6. H Schmidt5,
  7. P Moroni-Zentgraf5,
  8. HAM Kerstjens6
  1. 1Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK
  2. 2University of Cape Town, Cape Town, South Africa
  3. 3University of Pisa, Pisa, Italy
  4. 4Family Physician Airways Group of Canada, Ontaria, Canada
  5. 5Boehringer Ingelheim Pharma GmbH and Co. KG, Biberach an Der Riss, Germany
  6. 6University Medical Center Groningen, Groningen, The Netherlands

Abstract

Background Recent clinical trials have indicated that the long-acting antimuscarinic agent tiotropium, a once-daily long-acting bronchodilator, may provide benefit to patients with symptomatic asthma. We investigated primary efficacy data (lung function, risk of severe exacerbation and seven-question Asthma Control Questionnaire [ACQ-7] response) from five Phase III, randomised, double-blind, parallel-group trials that evaluated the efficacy and safety of once-daily tiotropium add-on versus placebo add-on (all tiotropium doses delivered via the Respimat® SoftMist™ inhaler) in adults with symptomatic asthma on inhaled corticosteroid (ICS) ± long-acting β2-agonist (LABA) maintenance therapy.

Methods Two 48-week trials of tiotropium Respimat® 5 µg (PrimoTinA-asthma®: NCT00776984, NCT00772538) in patients on high-dose ICS (≥800 µg budesonide or equivalent) + LABA; two 24-week trials of tiotropium Respimat® 5 µg and 2.5 µg (MezzoTinA-asthma®: NCT01172808, NCT01172821) in patients on moderate-dose ICS (400–800 µg budesonide or equivalent); one 12-week trial of tiotropium Respimat® 5 µg and 2.5 µg (GraziaTinA-asthma®: NCT01316380) in patients on low-dose ICS (200–400 µg budesonide or equivalent).

Results 3476 patients were treated, of whom 1128 received tiotropium Respimat® 5 µg. Once-daily tiotropium Respimat® 5 µg significantly improved lung function (Table) in patients with not fully controlled asthma receiving low- to high-dose ICS. In addition, tiotropium Respimat® 5 µg reduced the risk of severe exacerbations versus placebo (co-primary end point) in patients on high-dose ICS + LABA (hazard ratio 0.79; p = 0.0343), and there was an increase in ACQ-7 responder rate (co-primary end point) with the5 µg dose (odds ratio 1.32; p = 0.0308) compared with placebo in patients on moderate-dose ICS.

Conclusion Once-daily tiotropium Respimat® significantly improves lung function in adult patients with symptomatic asthma receiving a range of doses of ICS, including even high-dose ICS + LABA, suggesting a potential role for this treatment as add-on to ICS in adults with symptomatic asthma.

Abstract S92 Table 1

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