SESSION TITLE: Tiotropium and Asthma
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Monday, October 28, 2013 at 01:45 PM - 03:15 PM
PURPOSE: In two prior Phase III trials (NCT00772538; NCT00776984), tiotropium (via Respimat® Soft Mist™ Inhaler) was shown to improve FEV1 peak(0-3h) and trough FEV1 at 24 weeks, versus placebo, when used as add-on to ICS+LABA in symptomatic patients with severe persistent asthma. To evaluate the degree to which improvements in lung function are sustained over 24 hours with tiotropium, we performed pre-planned spirometric pulmonary function tests (PFTs) over a 24-hour period at week 24 of these trials.
METHODS: Two identical randomized, double-blind, placebo-controlled, 48-week, parallel-group trials of tiotropium 5 µg versus placebo. Inclusion criteria included: aged 18-75 years; asthma for ≥5 years; Asthma Control Questionnaire 7 score ≥1.5; post-bronchodilator FEV1 ≤80%; non-smoker/ex-smoker (<10 pack-years); ICS+LABA for ≥4 weeks pre-screening; ICS dose ≥800 µg budesonide or equivalent. Exclusion criteria included diagnosis of COPD or other lung diseases. PFTs were performed in a subset of patients at week 24, 10 minutes pre-dose (dose given between 7 AM and 10 AM) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23, and 24 hours post-dose, and response was defined as difference from baseline.
RESULTS: There was a statistically significant improvement in FEV1 AUC response over 24 hours with tiotropium versus placebo in both trials: Trial 1, n=176, difference from placebo (±SE): FEV1 AUC0-24h, 122±56 mL, p=0.031; FEV1 AUC0-12h, 134±58 mL, p=0.021; FEV1 AUC12-24h, 110±55 mL, p=0.045 Trial 2, n=173, difference from placebo (±SE): FEV1 AUC0-24h, 180±57 mL, p=0.002; FEV1 AUC0-12h, 184±58 mL, p=0.002; FEV1 AUC12-24h, 176±57 mL, p=0.002
CONCLUSIONS: Tiotropium is an effective once-daily additional bronchodilator for symptomatic patients who have severe persistent asthma despite treatment with ICS+LABA.
CLINICAL IMPLICATIONS: Tiotropium, given as once-daily add-on to ICS+LABA, provides clinically relevant and sustained improvements in lung function over 24 hours. Funding: Boehringer Ingelheim and Pfizer. Editorial assistance: Complete HealthVizion.
DISCLOSURE: Jonathan Corren: University grant monies: Boehringer Ingelheim for research, Other: Boehringer Ingelheim provided equipment for conducting clinical trial, Consultant fee, speaker bureau, advisory committee, etc.: Genentech and Merck, Other: Payment for development of educational presentations - Educational slide set, Genentech Anthony Frew: University grant monies: Boehringer Ingelheim, Payments for Study costs 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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