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 3085
VO 40
IS Suppl 56
A1 David Miller
A1 Craig LaForce
A1 Albert Finn
A1 Eric Bateman
A1 Kristin Drda
A1 Jon Blatchford
A1 Wanda Broderick
A1 Andrew Fowler
A1 Abhya Gupta
A1 Chester Wood
YR 2012
UL http://erj.ersjournals.com/content/40/Suppl_56/3085.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 administered once in the morning or evening versus a split twice daily dose compared to placebo 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, three period, incomplete cross-over study comparing BI 671800 400 mg AM, PM or 200 mg bid with matching placebo over 3 consecutive 4-week treatment periods. The primary study outcome was change in trough FEV1.Results 108 patients were randomised (mean age 41 yrs, FEV1 73%, ACQ 2.13). Change from baseline in mean (SE) trough morning FEV1 % predicted versus placebo were 0.08% (0.62), 0.67% (0.62) and 0.28% (0.61) and change in ACQ mean (SE) scores were -0.056 (0.063), -0.026 (0.063) and -0.093 (0.062) versus placebo for 200 bid, 400 PM, and 400 AM BI 671800 respectively (all values one-sided p > 0.025). No imbalance in adverse events, or differences in vital signs or laboratory assessments were observed.Conclusion Total daily treatment with 400 mg BI 671800 did not demonstrate additional effect on FEV1 on top of FP. BI 671800 was well tolerated at total daily doses of 400 mg for 4 weeks.