Burden of Asthma and Role of 2.5 µg Tiotropium Respimat® as an Add-On Therapy: A Systematic Review of Phase 2/3 Trials

Lyndon Mansfield, Sy Duong-Quy, Timothy Craig

Research output: Contribution to journalReview article

Abstract

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).

Original languageEnglish (US)
Pages (from-to)2587-2599
Number of pages13
JournalAdvances in Therapy
Volume36
Issue number10
DOIs
StatePublished - Oct 1 2019

Fingerprint

Asthma
Lung
Placebos
Therapeutics
Adrenal Cortex Hormones
Nasopharyngitis
Randomized Controlled Trials
Safety
Muscarinic Antagonists
Manuscripts
Vital Capacity
Forced Expiratory Volume
Tiotropium Bromide
PubMed
Respiratory Tract Infections
Age Groups
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

Cite this

@article{f73f117f4f264e229ed679e811399b4f,
title = "Burden of Asthma and Role of 2.5 µg Tiotropium Respimat{\circledR} as an Add-On Therapy: A Systematic Review of Phase 2/3 Trials",
abstract = "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{\circledR} 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{\circledR} 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{\circledR}, n = 1642; placebo, n = 1602) met the predefined inclusion criteria. Once-daily 2.5 µg tiotropium Respimat{\circledR} 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{\circledR} 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{\circledR} 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).",
author = "Lyndon Mansfield and Sy Duong-Quy and Timothy Craig",
year = "2019",
month = "10",
day = "1",
doi = "10.1007/s12325-019-01062-w",
language = "English (US)",
volume = "36",
pages = "2587--2599",
journal = "Advances in Therapy",
issn = "0741-238X",
publisher = "Health Communications Inc.",
number = "10",

}

Burden of Asthma and Role of 2.5 µg Tiotropium Respimat® as an Add-On Therapy : A Systematic Review of Phase 2/3 Trials. / Mansfield, Lyndon; Duong-Quy, Sy; Craig, Timothy.

In: Advances in Therapy, Vol. 36, No. 10, 01.10.2019, p. 2587-2599.

Research output: Contribution to journalReview article

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

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).

UR - http://www.scopus.com/inward/record.url?scp=85071339247&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85071339247&partnerID=8YFLogxK

U2 - 10.1007/s12325-019-01062-w

DO - 10.1007/s12325-019-01062-w

M3 - Review article

AN - SCOPUS:85071339247

VL - 36

SP - 2587

EP - 2599

JO - Advances in Therapy

JF - Advances in Therapy

SN - 0741-238X

IS - 10

ER -