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Tiotropium as add-on to inhaled corticosteroids significantly improves asthma control as reflected by the ACQ responder rate

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: P4130; 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: Despite current medications, there remains an unmet need for asthma control in patients with moderate asthma receiving at least ICS. We analysed ACQ data in patients treated with once-daily long-acting anticholinergic bronchodilator tiotropium who had symptomatic asthma despite treatment with medium-dose ICS (400-800 µg budesonide equivalent).

Methods: 2103 patients were randomised in 2 identical Phase III, double-blind, double-dummy, parallel-group studies (NCT01172808 and NCT01172821). Patients received tiotropium 2.5 µg or 5 µg or placebo (all doses via Respimat® Soft Mist™ Inhaler). A salmeterol arm (active comparator) was included with no inferential analysis. Key inclusion criteria included a pre-bronchodilator FEV1 60-90% of predicted and ACQ score ≥1.5. A pre-planned pooled analysis was performed for ACQ responder rate, a co-primary end point; responders were defined as ACQ improvement ≥0.5 at 24 weeks.

Results: Baseline characteristics in patients were similar across both trials and all treatment groups. Mean baseline ACQ total score was 2.18 (SD 0.49). Both doses of tiotropium significantly improved the ACQ responder rate at 24 weeks compared with placebo (299/518 responders; 57.7%): tiotropium 2.5 µg, 332/515 (64.5%; p=0.03); tiotropium 5 µg, 330/513 (64.3%; p=0.03); salmeterol 356/535 (66.5%; p=0.004).

Conclusion: In patients with symptomatic asthma despite ICS therapy, the addition of once-daily tiotropium provided a statistically significant and clinically relevant improvement in asthma control. A similar ACQ responder rate was observed with tiotropium (2.5 µg and 5 µg) and the active comparator salmeterol.

  • Bronchodilators
  • Asthma - management
  • Airway management
  • © 2013 ERS
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Tiotropium as add-on to inhaled corticosteroids significantly improves asthma control as reflected by the ACQ responder rate
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) P4130;

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Tiotropium as add-on to inhaled corticosteroids significantly improves asthma control as reflected by the ACQ responder rate
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) P4130;
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