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Obstructive Lung Diseases |

Once-Daily Tiotropium Respimat Reduces Risk of Severe Asthma Exacerbation and Asthma Worsening in Symptomatic Asthma, Independent of Allergic and Inflammatory Status FREE TO VIEW

Ronald Dahl; Thomas Casale; Mark Vandewalker; Hendrik Schmidt; Michael Engel; Petra Moroni-Zentgraf; Huib Kerstjens
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Odense University Hospital, Odense, Denmark


Chest. 2015;148(4_MeetingAbstracts):671A. doi:10.1378/chest.2280021
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Abstract

SESSION TITLE: Asthma Outcomes

SESSION TYPE: Original Investigation Slide

PRESENTED ON: Sunday, October 25, 2015 at 07:30 AM - 08:30 AM

PURPOSE: To explore whether tiotropium Respimat® add-on to at least ICS is effective in the T helper 2 phenotype, determined by high serum immunoglobulin E (IgE) and blood eosinophil values, in reducing risk of severe asthma exacerbation and asthma worsening in adult patients with moderate to severe symptomatic asthma.

METHODS: Four Phase III, double-blind, placebo-controlled, parallel-group trials: PrimoTinA-asthma® (two 48-week trials; NCT00776984/NCT00772538; n=912): tiotropium Respimat® 5 µg or placebo Respimat® add-on to high-dose ICS + LABA; MezzoTinA-asthma® (two 24-week trials; NCT01172808/NCT01172821; n=2100): tiotropium Respimat® 5 µg, tiotropium Respimat® 2.5 µg, or placebo add-on to medium-dose ICS. Patients had symptomatic asthma requiring treatment with at least ICS for ≥4 weeks before screening; COPD was excluded. Subgroups of allergic and inflammatory status (IgE and eosinophils) were used to analyze risk of severe exacerbation and asthma worsening, post hoc. Cox regression modeling analyses, adjusted for treatment, IgE or eosinophils and treatment by IgE or eosinophil interaction, were applied to calculate hazard ratios and 95% confidence intervals across IgE (2-2000 μg/L) and eosinophil (0.05-7.00×109/L) values.

RESULTS: Severe exacerbation: in PrimoTinA-asthma®, tiotropium Respimat® 5 µg reduced risk in terms of hazard ratio versus placebo Respimat® up to an IgE level of ~1000 µg/L, and consistently across all eosinophil values. In MezzoTinA-asthma®, tiotropium Respimat® 5 µg and 2.5 µg reduced risk versus placebo consistently across all IgE and eosinophil levels. Asthma worsening: in PrimoTinA-asthma®, tiotropium Respimat® 5 µg reduced risk in terms of hazard ratio versus placebo Respimat®, independent of IgE and eosinophils. In MezzoTinA-asthma®, tiotropium Respimat® 5 µg reduced risk versus placebo across all IgE and eosinophil values. Tiotropium Respimat® 2.5 µg reduced risk versus placebo across all IgE values and at eosinophil values <3.00×109/L.

CONCLUSIONS: Tiotropium Respimat® add-on to ICS ± LABA reduces risk of severe exacerbation and asthma worsening in patients across severities of symptomatic asthma and a broad range of IgE and eosinophil values, suggesting efficacy independent of underlying allergic/eosinophilic inflammation.

CLINICAL IMPLICATIONS: Once-daily tiotropium Respimat® may have potential as add-on to at least ICS maintenance therapy in patients with symptomatic asthma, independent of T helper 2 phenotype.

DISCLOSURE: Ronald Dahl: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim - advisory board, Consultant fee, speaker bureau, advisory committee, etc.: Novartis - advisory board, Consultant fee, speaker bureau, advisory committee, etc.: Meda - advisory board, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim - Speaker fee, Consultant fee, speaker bureau, advisory committee, etc.: Novartis - Speaker fee, Consultant fee, speaker bureau, advisory committee, etc.: Glaxo - Speaker fee, Other: Teva - expert testimony Thomas Casale: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim - advisory board, Other: Boehringer Ingelheim - served as investigator on grants from Boehringer Ingelheim to University employer Mark Vandewalker: Grant monies (from industry related sources): Boehringer Ingelheim - research grant, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim - consultant fee/honoraria Hendrik Schmidt: Employee: Boehringer Ingelheim Michael Engel: Employee: Boehringer Ingelheim Petra Moroni-Zentgraf: Employee: Boehringer Ingelheim Huib Kerstjens: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim - fees for consultancy, advisory board, presentations, and patient recruitment, Consultant fee, speaker bureau, advisory committee, etc.: Pfizer - fees for consultancy, advisory board, presentations, and patient recruitment, Consultant fee, speaker bureau, advisory committee, etc.: Almirall - consultancy, advisory board, Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca - consultancy, Consultant fee, speaker bureau, advisory committee, etc.: Chiesi - consultancy, Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline - consultancy, advisory board, speaker, Consultant fee, speaker bureau, advisory committee, etc.: Novartis - consultancy, advisory board, speaker

Spiriva® (tiotropium) Respimat® is approved for use in asthma in the EU, Japan and many other countries. The indication varies by country. It is currently being reviewed by the US regulatory authorities.


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