TY - JOUR
T1 - Burden of Asthma and Role of 2.5 µg Tiotropium Respimat® as an Add-On Therapy
T2 - A Systematic Review of Phase 2/3 Trials
AU - Mansfield, Lyndon
AU - Duong-Quy, Sy
AU - Craig, Timothy
N1 - Funding Information:
Development of the manuscript was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). The authors received no direct compensation related to the development of the manuscript. BIPI was given the opportunity to review the manuscript for medical and scientific accuracy, as well as intellectual property considerations. As Timothy Craig is a member of the Editorial Board the rapid service fee was waived.
Funding Information:
Development of the manuscript was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). The authors received no direct compensation related to the development of the manuscript. BIPI was given the opportunity to review the manuscript for medical and scientific accuracy, as well as intellectual property considerations. As Timothy Craig is a member of the Editorial Board the rapid service fee was waived. Writing, editorial support, and formatting assistance was provided by Saurabh Gagangras, PhD, and Maribeth Bogush, MCI, PhD, of Cactus Communications, which was contracted and compensated by BIPI for these services. The authors meet the criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE), take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. The sponsor also provided medical, regulatory, legal, and IP review of the final draft manuscript; suggestions were incorporated at the author?s discretion. Lyndon Mansfield has received research grants from Teva, Pearl, GlaxoSmithKline, Novartis, Amphastar, Aimmune, Cipla, West-Ward, Sanofi, Chiesi, and Lupin. Sy Duong-Quy has nothing to disclose. Timothy Craig has received research grants from Genentech, Boehringer Ingelheim, AstraZeneca, GlaxoSmithKline, Regeneron, and Novartis, and has received traveling grants from and is on the speakers? bureau for GlaxoSmithKline and Regeneron. This article is based on previously conducted studies and does not contain any studies with human participants or animals performed by any of the authors. Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
Publisher Copyright:
© 2019, The Author(s).
PY - 2019/10/1
Y1 - 2019/10/1
N2 - Introduction: Tiotropium, a long-acting muscarinic antagonist, is approved for maintenance treatment of asthma in patients at least 6 years of age in the USA. We systematically reviewed published evidence on the efficacy and safety of 2.5 µg tiotropium Respimat® add-on therapy to inhaled corticosteroid (ICS) with or without additional controller medication(s) in children, adolescents, and adults with asthma. Methods: We searched PubMed from inception until October 3, 2018, for phase 2 and 3 randomized controlled trials (RCTs) evaluating the effects of 2.5 µg tiotropium Respimat® on lung function parameters in patients with asthma. We extracted adjusted mean differences for lung function data and adverse events (AEs) from relevant articles. Results: Overall, 11 RCTs (three phase 2 and eight phase 3 studies) including 3244 patients (2.5 µg tiotropium Respimat®, n = 1642; placebo, n = 1602) met the predefined inclusion criteria. Once-daily 2.5 µg tiotropium Respimat® improved lung function parameters, including peak and trough forced expiratory volume in 1 s and peak and trough forced vital capacity, versus placebo. Overall, the safety profile of 2.5 µg tiotropium Respimat® was comparable to that of placebo, with the most commonly reported AEs being asthma worsening, reduction in peak expiratory rate, nasopharyngitis, and respiratory tract infections. Conclusion: On the basis of the results of phase 2 and 3 studies, 2.5 µg tiotropium Respimat® as add-on to ICS therapy was safe and associated with consistent improvements in lung function in patients with asthma of varying severities across different age groups. Funding: Development of the manuscript was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI).
AB - Introduction: Tiotropium, a long-acting muscarinic antagonist, is approved for maintenance treatment of asthma in patients at least 6 years of age in the USA. We systematically reviewed published evidence on the efficacy and safety of 2.5 µg tiotropium Respimat® add-on therapy to inhaled corticosteroid (ICS) with or without additional controller medication(s) in children, adolescents, and adults with asthma. Methods: We searched PubMed from inception until October 3, 2018, for phase 2 and 3 randomized controlled trials (RCTs) evaluating the effects of 2.5 µg tiotropium Respimat® on lung function parameters in patients with asthma. We extracted adjusted mean differences for lung function data and adverse events (AEs) from relevant articles. Results: Overall, 11 RCTs (three phase 2 and eight phase 3 studies) including 3244 patients (2.5 µg tiotropium Respimat®, n = 1642; placebo, n = 1602) met the predefined inclusion criteria. Once-daily 2.5 µg tiotropium Respimat® improved lung function parameters, including peak and trough forced expiratory volume in 1 s and peak and trough forced vital capacity, versus placebo. Overall, the safety profile of 2.5 µg tiotropium Respimat® was comparable to that of placebo, with the most commonly reported AEs being asthma worsening, reduction in peak expiratory rate, nasopharyngitis, and respiratory tract infections. Conclusion: On the basis of the results of phase 2 and 3 studies, 2.5 µg tiotropium Respimat® as add-on to ICS therapy was safe and associated with consistent improvements in lung function in patients with asthma of varying severities across different age groups. Funding: Development of the manuscript was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI).
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U2 - 10.1007/s12325-019-01062-w
DO - 10.1007/s12325-019-01062-w
M3 - Review article
C2 - 31435830
AN - SCOPUS:85071339247
SN - 0741-238X
VL - 36
SP - 2587
EP - 2599
JO - Advances in Therapy
JF - Advances in Therapy
IS - 10
ER -