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P148 Once-daily tiotropium Respimat® add-on to at least ICS maintenance therapy reduces exacerbation risk in patients with uncontrolled symptomatic asthma
  1. D Halpin1,
  2. ED Bateman2,
  3. P Paggiaro3,
  4. ER Bleecker4,
  5. M Engel5,
  6. P Moroni-Zentgraf5,
  7. H Schmidt6,
  8. HAM Kerstjens7
  1. 1Royal Devon & Exeter Hospital, Exeter, UK
  2. 2University of Cape Town, Cape Town, South Africa
  3. 3Respiratory Pathophysiology and Rehabilitation Unit, University of Pisa, Pisa, Italy
  4. 4Center for Genomics and Personalized Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA
  5. 5TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim Am Rhein, Germany
  6. 6Global Biometrics and Clinical Applications, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an Der Riss, Germany
  7. 7University of Groningen, Department of Pulmonary Medicine, University Medical Center Groningen, Groningen, The Netherlands

Abstract

Background A reduction in the risk of asthma exacerbation may provide improvements in clinical burden, patient experience and healthcare costs. In Phase III trials, once-daily tiotropium Respimat® add-on to at least ICS improved lung function in patients with symptomatic asthma. We investigated exacerbation risk in each trial.

Methods Five Phase III, double-blind, placebo-controlled, parallel-group trials in patients with symptomatic asthma. Patients received tiotropium Respimat® 5 µg or placebo Respimat® each as add-on to at least ICS maintenance therapy (Table 1). Pre-planned co-primary or secondary end points were time to first severe exacerbation and time to any asthma worsening.

Abstract P148 Table 1

Risk of severe asthma exacerbation in PrimoTinA-asthma®, MezzoTinA-asthma® and GraziaTinA-asthma®

Results Mean baseline% of predicted FEV1, ACQ-7 score and ICS dose (µg) were: 56.0 ± 13.1, 2.6 ± 0.7 and 1198 ± 539 in PrimoTinA-asthma® (two replicate trials); 75.1 ± 11.5, 2.2 ± 0.5 and 660 ± 213 in MezzoTinA-asthma® (two replicate trials); and 77.7 ± 11.9, 2.1 ± 0.4 and 381 ± 78 in GraziaTinA-asthma®. Tiotropium Respimat® 5 µg reduced risk of severe asthma exacerbation by at least 21% in all three severity cohorts (Table 1) and risk of asthma worsening versus placebo Respimat® in all trials, with a statistically significant reduction in PrimoTinA-asthma®.

Conclusion Once-daily tiotropium Respimat® 5 µg add-on to at least ICS maintenance therapy consistently reduced exacerbations across asthma severities and so may be a beneficial add-on option to reduce current and future exacerbation risk.

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