Source: Annual Congress 2012 - New bronchodilators and other novel drugs for asthma and COPD
Disease area: Airway diseases

Abstract

Background BI 671800 is an antagonist of the PGD2 receptor, CRTH2. PGD2 stimulates bronchoconstriction and allergic airway inflammation in animal models. Inhibition of CRTH2 may reduce airway inflammatory cells, IL -4, -5, -13 production, serum IgE and airway hyper reactivity.
Objective To investigate the efficacy and safety of BI 671800 versus placebo and fluticasone proprionate (FP) in controller-naïve patients with poorly-controlled asthma.
Methods Adults with asthma (FEV₁ 60-85% and ACQ >= 1.5) were enrolled in a randomized, double-blind, parallel arm study comparing BI 671800 50, 200 or 400 mg bid with matching placebo bid or FP 110 µg bid for six weeks. The primary study outcome was change in trough FEV₁.
Results 388 patients were randomised (mean age 37.4 years, FEV₁ 72.7%, ACQ 2.29). Changes from baseline in adjusted mean (SE) trough morning FEV₁% predicted versus placebo were 3.08% (1.65), 3.59% (1.60) and 3.98% (1.64) for 50, 200 and 400 mg BI 671800 bid respectively, and 8.61% (1.68) for FP (one-sided p < 0.025 for 200 and 400 mg bid and FP), achieving the primary efficacy outcome for the study. Change in ACQ mean (SE) scores versus placebo were 0.07 (0.11), -0.08 (0.11) and -0.06 (0.11) for 50, 200 and 400 mg BI 671800 bid respectively, and -0.33 (0.12) for FP (one sided p < 0.025 for FP). No significant imbalance in adverse events, or differences in vital signs or laboratory assessments were observed.
Conclusion Treatment with BI 671800 was associated with a significant improvement in FEV₁ in controller-naïve patients with poorly-controlled asthma. BI 671800 was well tolerated at total daily doses up to 800 mg for 6 weeks.

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R. Sutherland, K. Tetzlaff, C. Nivens, M. Tsukayama, A. Guerreros, R. Manuel, E. Bateman, J. Blatchford, A. Fowler, A. Gupta (Denver, Ridgefield, United States Of America; Biberach an der Riss, Germany; Lima, Peru; Cape Town, South Africa; Bracknell, United Kingdom). Efficacy and safety of BI 671800, an oral CRTH2 antagonist in controller naïve patients with poorly-controlled asthma. Eur Respir J 2012; 40: Suppl. 56, 3084

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