Tiotropium for the treatment of asthma in adolescents

ABSTRACT

Introduction: Asthma is a prevalent disease affecting millions of individuals. Despite receiving guideline therapy with inhaled corticosteroids (ICS) with or without a long-acting β₂-agonist (LABA), a proportion of patients remain symptomatic or have suboptimal lung function. There is therefore an unmet need for additional therapies to improve asthma control. The long-acting anticholinergic tiotropium, delivered via the Respimat inhaler, is approved for the treatment of asthma in the EU, the USA, and other countries. Phase III investigation in adults has demonstrated that tiotropium improves lung function and asthma control, with a safety profile comparable with that of placebo.

Areas covered: Clinical trials in adolescent patients (aged 12–17 years) with moderate or severe symptomatic asthma have shown that tiotropium Respimat as add-on to ICS, with or without other maintenance therapies, is a well-tolerated and efficacious bronchodilator showing trends toward improved asthma control, similar to data in adult patients.

Expert opinion: Tiotropium Respimat may be of benefit as add-on maintenance therapy to medium- or high-dose ICS with or without LABA; however, further data are needed to directly compare the efficacy of ICS plus tiotropium versus ICS plus LABA in adolescents with symptomatic asthma, and to establish the long-term effects on airway modeling.

KEYWORDS:

• Adolescents
• asthma
• long-acting muscarinic agonist
• tiotropium

Article highlights

• Once-daily tiotropium as add-on to ICS, with or without other maintenance therapies, has been shown to be an efficacious bronchodilator in Phase II and III trials in over 4500 adult asthma patients

• In Phase II and III trials in adolescents with moderate or severe symptomatic asthma, once-daily tiotropium add-on therapy improved lung function and showed trends toward improved asthma control

• The safety and tolerability of tiotropium add-on therapy in these adolescent asthma patients were comparable with those of placebo

• Tiotropium may be well placed as a third controller medication in adolescent patients with poorly controlled asthma, as an add-on to medium- or high-dose ICS plus a LABA, or as a second controller added on to medium- or high-dose ICS alone

This box summarizes key points contained in the article.

Declaration of interest

E. Hamelmann receives grants from the Dutch Ministry of Health and has served as a consultant for Aerocrine, Allergopharma, ALK, Bencard Allergie, Boehringer Ingelheim, HAL Allergy, LETI, Novartis, and Stallergenes. S. J. Szefler has served as a consultant for Aerocrine, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Genentech, GlaxoSmithKline, Hoffman La Roche, Merck, Novartis, Roche, Sanofi, and Teva. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. The authors take full responsibility for the scope, direction, content of, and editorial decisions relating to the manuscript, were involved at all stages of development, and have approved the submitted manuscript.

Medical writing assistance, in the form of the preparation and revision of the manuscript, was supported financially by Boehringer Ingelheim and provided by Helen Woodroof, PhD, at Complete HealthVizion under the authors’ conceptual direction and based on feedback from the authors.

Additional information

Funding

This work was supported financially by Boehringer Ingelheim. Boehringer Ingelheim was not involved in the development of this publication and reviewed the final version for scientific accuracy only. S J Szefler reports grants from the Colorado Department of Public Health and Environment [13-FLA-48556 and 17-FHLA-93211], the National Heart, Lung, and Blood Institute Asthma Research Network [1 U10 HL098075-01], and GlaxoSmithKline Inner City Asthma School Program Building Bridges [FLV116794].