TY - JOUR
T1 - Tiotropium Respimat Efficacy and Safety in Asthma
T2 - Relationship to Age
AU - Doherty, Dennis E.
AU - Bleecker, Eugene R.
AU - Moroni-Zentgraf, Petra
AU - Zaremba-Pechmann, Liliana
AU - Kerstjens, Huib A.M.
N1 - Funding Information:
We thank the investigators and patients at the investigative sites for their support of these studies. We also thank Michael Engel and Ralf Sigmund (Boehringer Ingelheim, Germany) for their input into the development of this manuscript. Writing support was provided by David Young of Young Medical Communications and Consulting Ltd , which was contracted and funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.
Funding Information:
The studies were funded by Boehringer Ingelheim, as were these pooled analyses.Conflicts of interest: D. E. Doherty reports receiving a grant from the National Institutes of Health, National Heart, Lung, and Blood Institute during the conduct of the studies presented in this article. Outside the submitted work he also reports receiving fees for consultancy services from Boehringer Ingelheim, and speaker fees from Boehringer Ingelheim and AstraZeneca. E. R. Bleecker has undertaken clinical trials through his previous employer, Wake Forest School of Medicine, and currently by the University of Arizona, for AstraZeneca, MedImmune, Boehringer Ingelheim, Cephalon/Teva, Genentech, Novartis, Regeneron, and Sanofi Genzyme; and has also served as a paid consultant for AstraZeneca, MedImmune, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Regeneron, and Sanofi Genzyme. All these were outside the submitted work. P. Moroni-Zentgraf is an employee of Boehringer Ingelheim, the sponsor of the studies presented in this article. L. Zaremba-Pechmann is a contractor of Boehringer Ingelheim, the sponsor of the studies presented in this article. H. A. M. Kerstjens has participated in part of the trials reported in this article and has received fees for participation in advisory boards from Boehringer Ingelheim. Outside the submitted work, he reports fees for advisory board membership from GlaxoSmithKline, Novartis, and Chiesi, and consultancy fees from GlaxoSmithKline, Novartis, Chiesi, and AstraZeneca. All the above were paid to his institution. His institution has also received unrestricted research and educational grants from Boehringer Ingelheim, Novartis, GlaxoSmithKline.We thank the investigators and patients at the investigative sites for their support of these studies. We also thank Michael Engel and Ralf Sigmund (Boehringer Ingelheim, Germany) for their input into the development of this manuscript. Writing support was provided by David Young of Young Medical Communications and Consulting Ltd, which was contracted and funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.
Publisher Copyright:
© 2020 The Authors
PY - 2020/9
Y1 - 2020/9
N2 - Background: Data are limited on the differential response to long-acting bronchodilators in older versus younger adults with asthma. Objective: To determine whether the response to tiotropium Respimat differed in older versus younger patients with asthma. Methods: Post hoc analyses of 4 randomized, double-blind, placebo-controlled studies in adults with asthma were carried out. Two studies compared tiotropium Respimat 5 μg once daily with placebo, both added to high-dose inhaled corticosteroid (ICS) plus long-acting β2-agonist (ie, severe asthma). The other 2 evaluated tiotropium Respimat 2.5 or 5 μg once daily, salmeterol 50 μg twice daily, or placebo, all added to medium-dose ICS (moderate asthma). Data were analyzed in 2 pools: (1) severe and (2) moderate asthma. Efficacy end points: trough and peak FEV1; trough forced vital capacity; Asthma Control Questionnaire total score and responder percentage, all at week 24. One set of analyses was performed with age as a continuous covariate; the second was conducted in categories less than 40, 40 to 60, and more than 60 years, with treatment-by-age subgroup interaction P values obtained. Safety was analyzed in age categories. Results: Across the age categories, treatment-by-age subgroup interaction P values for trough FEV1 were.13 and.77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the 2 continuum analyses. The other end points (including safety) were also not impacted by age. Conclusions: Once-daily tiotropium Respimat add-on to ICS or ICS/long-acting β2-agonist therapy was effective and well tolerated in patients with asthma independent of age.
AB - Background: Data are limited on the differential response to long-acting bronchodilators in older versus younger adults with asthma. Objective: To determine whether the response to tiotropium Respimat differed in older versus younger patients with asthma. Methods: Post hoc analyses of 4 randomized, double-blind, placebo-controlled studies in adults with asthma were carried out. Two studies compared tiotropium Respimat 5 μg once daily with placebo, both added to high-dose inhaled corticosteroid (ICS) plus long-acting β2-agonist (ie, severe asthma). The other 2 evaluated tiotropium Respimat 2.5 or 5 μg once daily, salmeterol 50 μg twice daily, or placebo, all added to medium-dose ICS (moderate asthma). Data were analyzed in 2 pools: (1) severe and (2) moderate asthma. Efficacy end points: trough and peak FEV1; trough forced vital capacity; Asthma Control Questionnaire total score and responder percentage, all at week 24. One set of analyses was performed with age as a continuous covariate; the second was conducted in categories less than 40, 40 to 60, and more than 60 years, with treatment-by-age subgroup interaction P values obtained. Safety was analyzed in age categories. Results: Across the age categories, treatment-by-age subgroup interaction P values for trough FEV1 were.13 and.77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the 2 continuum analyses. The other end points (including safety) were also not impacted by age. Conclusions: Once-daily tiotropium Respimat add-on to ICS or ICS/long-acting β2-agonist therapy was effective and well tolerated in patients with asthma independent of age.
KW - Aging
KW - Asthma
KW - Long-acting muscarinic antagonist
KW - Long-acting β-agonists
KW - Pharmacotherapy
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U2 - 10.1016/j.jaip.2020.04.013
DO - 10.1016/j.jaip.2020.04.013
M3 - Article
C2 - 32320797
AN - SCOPUS:85084408047
SN - 2213-2198
VL - 8
SP - 2653-2660.e4
JO - Journal of Allergy and Clinical Immunology: In Practice
JF - Journal of Allergy and Clinical Immunology: In Practice
IS - 8
ER -