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Tiotropium as add-on therapy to inhaled corticosteroids for patients with symptomatic asthma: Lung function and safety

H.A.M. Kerstjens, E. Bleecker, E. Meltzer, T. Casale, E. Pizzichini, O. Schmidt, M. Engel, L.J. Bour, C.B. Verkleij, P.M. Moroni-Zentgraf, E.D. Bateman
European Respiratory Journal 2013 42: 4629; DOI:
H.A.M. Kerstjens
1Department of Pulmonary Medicine, University Medical Center Groningen, University of Groningen, Groningen, Netherlands
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E. Bleecker
2Center for Genomics and Personalized Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States
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E. Meltzer
3Allergy & Asthma Medical Group & Research Center, San Diego, CA, United States
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T. Casale
4Division of Allergy and Immunology, Creighton University, Omaha, NE, United States
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E. Pizzichini
5NUPAIVA (Asthma Research Centre), Universidade Federal De Santa Catarina, Santa Catarina, Brazil
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O. Schmidt
6KPPK GmbH, Koblenz, Germany
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M. Engel
7TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
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L.J. Bour
8Biostatistics, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
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C.B. Verkleij
9Medical Department, Boehringer Ingelheim BV, Alkmaar, Netherlands
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P.M. Moroni-Zentgraf
7TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
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E.D. Bateman
10Department of Medicine, University of Cape Town, Cape Town, South Africa
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Abstract

Background: Asthma is not controlled in some patients, despite using medium-dose ICS.

Methods: Two identical Phase III, randomised, double-blind, double-dummy, placebo (pbo)-controlled, parallel-group trials (NCT01172808/821) assessed tiotropium (tio) efficacy/safety. Patients with symptomatic asthma and pre-bronchodilator FEV1 60-90% predicted, using medium-dose ICS (400-800µg budesonide equivalent), were randomised to once-daily tio 5µg or 2.5µg (via Respimat® Soft Mist™ Inhaler), salmeterol (sal, active comparator without inferential analysis) or pbo. Other LABAs were not permitted. Pre-specified co-primary end points included peak FEV1(0-3h) and trough FEV1 response at 24 wks.

Results: Baseline characteristics were similar between trials/treatment groups in 2103 randomised patients (2100 treated); mean post-bronchodilator FEV1 88.8% predicted. Both tio doses showed significant improvements vs pbo: mean change from baseline in peak FEV1(0-3h) at 24 wks: 236 mL (tio 2.5µg)/198 mL (tio 5µg) greater than pbo in trial 1 (sal 213 mL); 211 mL (tio 2.5µg) or 169 mL (tio 5µg) greater in trial 2 (all p<0.0001) (sal 176 mL). FEV1 trough response at 24 wks: 185 mL (tio 2.5µg)/152 mL (tio 5µg) greater in trial 1 (sal 123 mL); 176 mL (tio 2.5µg)/133 mL (tio 5µg) greater in trial 2 (all p<0.0001) (sal 106 mL). Discontinuation due to adverse events (AEs): pbo, 2.5%; tio 2.5µg, 1.2%; tio 5µg, 1.9%, sal, 1.8%. No fatal events. AEs balanced across treatment groups.

Conclusion: In patients with symptomatic asthma and airflow limitation despite medium-dose ICS, addition of once-daily tiotropium provides sustained bronchodilation (efficacy comparable to sal) and is well tolerated.

  • Asthma - management
  • Bronchodilators
  • Lung function testing
  • © 2013 ERS
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Tiotropium as add-on therapy to inhaled corticosteroids for patients with symptomatic asthma: Lung function and safety
H.A.M. Kerstjens, E. Bleecker, E. Meltzer, T. Casale, E. Pizzichini, O. Schmidt, M. Engel, L.J. Bour, C.B. Verkleij, P.M. Moroni-Zentgraf, E.D. Bateman
European Respiratory Journal Sep 2013, 42 (Suppl 57) 4629;

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Tiotropium as add-on therapy to inhaled corticosteroids for patients with symptomatic asthma: Lung function and safety
H.A.M. Kerstjens, E. Bleecker, E. Meltzer, T. Casale, E. Pizzichini, O. Schmidt, M. Engel, L.J. Bour, C.B. Verkleij, P.M. Moroni-Zentgraf, E.D. Bateman
European Respiratory Journal Sep 2013, 42 (Suppl 57) 4629;
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