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Allergy and Airway |

Improvements in Lung Function With Tiotropium as Add-On Controller Therapy to ICS+LABA for Patients With Symptomatic Severe Asthma

Dennis E Doherty, MD; Donald P Tashkin, MD; Tim W Harrison, MD; Michael Engel, MD; Hendrik Schmidt, PhD; Petra Moroni-Zentgraf, MD; Huib AM Kerstjens, MD
Author and Funding Information

Lexington VA Medical Center, University of Kentucky, Lexington, KY


Chest. 2013;144(4_MeetingAbstracts):88A. doi:10.1378/chest.1702143
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Abstract

SESSION TITLE: Tiotropium and Asthma

SESSION TYPE: Original Investigation Slide

PRESENTED ON: Monday, October 28, 2013 at 01:45 PM - 03:15 PM

PURPOSE: A considerable proportion of asthma patients remain symptomatic despite treatment with ICS+LABA, and there is a need for additional controller medications. We present results from one Phase II (trial 1: NCT00365560) and two replicate Phase III (trials 2a/2b: NCT00772538, NCT00776984) trials that assessed efficacy and safety of the long-acting anticholinergic bronchodilator tiotropium (via Respimat® Soft Mist™ Inhaler) as add-on to ICS+LABA in patients with severe symptomatic asthma.

METHODS: Trial 1: randomized, double-blind, placebo-controlled, 8-week, crossover study of tiotropium 5 and 10 µg versus placebo. Trials 2a/2b: identical double-blind, placebo-controlled, 48-week, parallel-group trials of tiotropium 5 µg versus placebo. Inclusion criteria common to all trials: aged 18-75 years; asthma for ≥5 years; ACQ-7 score ≥1.5; post-bronchodilator FEV1 ≤80%; non-smoker/ex-smoker (<10 pack-years); ICS+LABA for ≥4 consecutive weeks pre-screening; daily ICS dose ≥800 µg budesonide/equivalent. COPD/other lung diseases excluded. Results presented as difference from baseline.

RESULTS: Trial 1: n=107; statistically significant improvement with tiotropium 5 and 10 µg in FEV1 peak(0-3h) response at 8 weeks (mean difference from placebo [±SE], 139±22 mL [p<0.001] and 170±22 mL [p<0.001], respectively), with only numerical difference between tiotropium doses. Trials 2a/2b: n=912; statistically significant improvement with tiotropium 5 µg in FEV1 peak(0-3h) and trough FEV1 response at 24 weeks (mean difference from placebo [±SE], trial 2a: 86±34 mL [p=0.011] and 88±31 mL [p=0.005], respectively; trial 2b: 154±32 mL [p<0.001] and 111±30 mL [p<0.001], respectively); FEV1 peak(0-3h) responses sustained at 48 weeks; statistically significant improvement in FVC peak(0-3h) and trough FVC responses with tiotropium 5 µg versus placebo; statistically significant improvements in weekly AM and PM PEF with tiotropium versus placebo, sustained over 48 weeks. AEs were balanced across treatment groups in each trial except for higher incidence of dry mouth with tiotropium 10 µg in trial 1.

CONCLUSIONS: Once-daily tiotropium as add-on to ICS+LABA provides significant and sustained improvements in lung function, and is well tolerated.

CLINICAL IMPLICATIONS: Once-daily tiotropium is an effective additional controller medication for patients with severe symptomatic asthma. Funding: Boehringer Ingelheim and Pfizer. Editorial assistance: Complete HealthVizion.

DISCLOSURE: Dennis E Doherty: University grant monies: University of Kentucky, Principal Investigator (PI), Fiduciary position (of any organization, association, society, etc, other than ACCP: Board membership, National Association for the Medical Direction of Respiratory Care (NAMDRC), Fiduciary position (of any organization, association, society, etc, other than ACCP: Board membership, National Lung Health Education Program (NLHEP), Fiduciary position (of any organization, association, society, etc, other than ACCP: Board membership, National Respiratory Training Center (NRTC), Consultant fee, speaker bureau, advisory committee, etc.: Consultancy for Forest and Merck , University grant monies: Grants/grants pending, Boehringer Ingelheim Pharmaceuticals, University grant monies: Grants/grants pending, Merck, University grant monies: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), University grant monies: Veterans Administration (VA), Consultant fee, speaker bureau, advisory committee, etc.: Payment for lectures including service on speakers bureaus, Astra-Zeneca, Consultant fee, speaker bureau, advisory committee, etc.: Boerhringer Ingelheim, Forest, Merck and Pfizer Donald P Tashkin: University grant monies: Boehringer Ingelheim, Pearl, , Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Consultancy for AstraZeneca, Novartis, Pearl Tim W Harrison: Consultant fee, speaker bureau, advisory committee, etc.: Consultancy fee - Travelling and accommodation expanses from BI to attend ATS Michael Engel: Employee: Boehringer Ingelheim Hendrik Schmidt: Employee: Boehringer Ingelheim Petra Moroni-Zentgraf: Employee: Boehringer Ingelheim Huib AM Kerstjens: University grant monies: Board membership - Pfizer, Almirall, GlaxoSmithKline, Takeda, Novartis, Nycomed, Chiesi, Consultant fee, speaker bureau, advisory committee, etc.: Consultancy fee - Pfizer, Almirall, GlaxoSmithKline, Novartis, Nycomed, Chiesi, AstraZeneca, Protaffin, Consultant fee, speaker bureau, advisory committee, etc.: Speaker bureau - BI, Pfizer

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