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S91 Once-daily tiotropium Respimat® add-on to ICS + LABA improves symptom control and reduces exacerbations in patients with symptomatic asthma
  1. D Price1,
  2. M Engel2,
  3. P Moroni-Zentgraf2,
  4. H Schmidt2,
  5. R Dahl3,
  6. P Paggiaro4,
  7. M Vandewalker5,
  8. HAM Kerstjens6,
  9. A Kaplan7
  1. 1Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK
  2. 2Boehringer Ingelheim Pharma GmbH and Co. KG, Biberach an Der Riss, Germany
  3. 3Odense University Hospital, Odense, Denmark
  4. 4University of Pisa, Pisa, Italy
  5. 5Clinical Research of the Ozarks, Colombia, USA
  6. 6University Medical Center Groningen, Groningen, The Netherlands
  7. 7Family Physician Airways Group of Canada, Ontaria, Canada

Abstract

Background We evaluated the effect of once-daily tiotropium Respimat® 5 µg on lung function, asthma exacerbation and asthma symptom control among patients with symptomatic asthma receiving inhaled corticosteroids (ICS; ≥800 μg/day budesonide or equivalent) + long-acting β2-agonist (LABA).

Methods Data were pooled from two replicate, double-blind, placebo-controlled, 48-week, parallel-group studies of once-daily tiotropium 5 µg versus placebo, both delivered via the Respimat® SoftMist™ inhaler (PrimoTinA-asthma®: NCT00772538, NCT00776984). Eligible patients had: ≥5-year history of asthma diagnosed before the age of 40 years; seven-question Asthma Control Questionnaire (ACQ-7) score of ≥1.5; experienced ≥1 exacerbation during the previous year. Patients were either lifelong non-smokers, or ex-smokers (<10 pack-years) who quit smoking ≥1 year before study enrolment. Exclusion criteria included diagnosis of chronic obstructive pulmonary disease. Co-primary end points in individual trials: peak forced expiratory volume in 1 second (FEV1) within 3 h post-dose (0–3 h) and trough FEV1. A co-primary end point in pooled data was time to first severe exacerbation; secondary end points included time to first episode of asthma worsening and ACQ-7 response. Post hoc efficacy analyses were performed.

Results 912 patients were randomised to receive tiotropium Respimat® (n = 456) or placebo Respimat® (n = 456). At Week 48, tiotropium Respimat® was associated with statistically significant improvements versus placebo Respimat® in peak FEV1(0–3h) (adjusted mean difference 100 mL; 95% confidence interval: 52, 148; p < 0.0001) and trough FEV1 (adjusted mean difference 62 mL; 95% confidence interval: 18, 106; p = 0.006). Time to first severe asthma exacerbation was significantly longer with tiotropium Respimat® versus placebo Respimat® (282 vs 226 days, respectively; hazard ratio 0.79; p = 0.034), as was time to first episode of asthma worsening (315 vs 181 days, respectively; hazard ratio 0.69; p < 0.0001). At Week 24, ACQ-7 responder rate was significantly higher with tiotropium Respimat® (53.9%) versus placebo Respimat® (46.9%; odds ratio 1.32; p = 0.0427).

Conclusion Once-daily tiotropium Respimat® add-on to ICS + LABA improves lung function, reduces risk of severe asthma exacerbation and asthma worsening, and significantly improves asthma symptom control compared with placebo Respimat® in patients with symptomatic asthma.

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