RT Journal Article
SR Electronic
T1 Efficacy and safety of BI 671800, an oral CRTH2 antagonist, as add on therapy in poorly controlled asthma patients prescribed an inhaled corticosteroid
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P1792
VO 40
IS Suppl 56
A1 Ian Hall
A1 Maria Sarno
A1 Bernd Disse
A1 Sibel Atis
A1 Ekkehard Beck
A1 Eric Bateman
A1 Helen Finnigan
A1 Christoph Hallmann
A1 Abhya Gupta
A1 Andrew Fowler
YR 2012
UL http://erj.ersjournals.com/content/40/Suppl_56/P1792.abstract
AB 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 montelukast in poorly controlled asthma patients as add on therapy to fluticasone propionate (FP) MDI (88 μg, bid).Methods Adults with asthma (FEV1 60-85% and ACQ >= 1.5) were enrolled in a randomized, double-blind, parallel arm study comparing BI 671800 400 mg bid with matching placebo bid or montelukast 10 mg qd for six weeks. The primary study outcome was change in trough FEV1.Results 243 patients were randomised (mean age 41.6 years, FEV1 72%, ACQ 2.1). Change from baseline in adjusted mean (SE) trough morning FEV1% predicted versus placebo was 3.87% (1.49) for BI 671800 and 2.37% (1.57) for montelukast, (one sided p < 0.025 for BI 671800), achieving the primary efficacy outcome for the study. Change in ACQ mean (SE) scores versus placebo were -0.28 (0.12) and -0.18 (0.12) for BI 671800 and montelukast respectively (one sided p < 0.025 for BI 671800). No significant imbalance in adverse events, or differences in vital signs or laboratory assessments were observed.Conclusion Treatment with BI 671800 in poorly controlled asthmatic patients receiving FP was associated with a significant improvement in FEV1. BI 671800 was well tolerated at a total daily dose of 800 mg for 6 weeks.