title: Efficacy of BI 671800, an oral CRTH2 antagonist, in poorly controlled asthma as sole controller and in the presence of inhaled corticosteroid treatment.
abstract: The prostaglandin D2 (PGD2) receptor, CRTH2, plays a role in allergic airway inflammation. The efficacy of BI 671800, a CRTH2 antagonist, was assessed in 2 separate trials in patients with asthma, in either the absence or the presence of inhaled corticosteroid (ICS) therapy. In this study, BI 671800 (50, 200 or 400 mg) and fluticasone propionate (220 μg) all given twice daily (bid) were compared with bid placebo in symptomatic controller-naïve adults with asthma (Trial 1), and BI 671800 400 mg bid compared with montelukast 10 mg once daily (qd), and matching placebo bid, in patients with asthma receiving inhaled fluticasone (88 μg bid) (Trial 2). The primary endpoint in both trials was change from baseline in trough forced expiratory volume in 1 s (FEV1) percent predicted. After 6 weeks' treatment, adjusted mean treatment differences (SE) for the primary endpoint compared with placebo in Trial 1 were 3.08% (1.65%), 3.59% (1.60%) and 3.98% (1.64%) for BI 671800 50, 200 and 400 mg bid, respectively, and 8.62% (1.68%) for fluticasone 220 μg bid (p = 0.0311, p = 0.0126, p = 0.0078 and p < 0.0001, respectively). In Trial 2, adjusted mean FEV1 (SE) treatment differences compared with placebo were 3.87% (1.49%) for BI 671800 400 mg bid and 2.37% (1.57%) for montelukast (p = 0.0050 and p = 0.0657, respectively). These findings suggest that BI 671800 is associated with a small improvement in FEV1 in symptomatic controller-naïve asthma patients, and in patients on ICS.
authors: Division of Respiratory Medicine, University of Nottingham, Nottingham, UK. Electronic address: Ian.Hall@nottingham.ac.uk.
authors: Ian P
authors: IP
authors: Hall
authors: Clinical Development & Medical Affairs/Therapeutic Area Respiratory Diseases, Boehringer Ingelheim Ltd., Bracknell, UK. Electronic address: Andy.Fowler@boehringer-ingelheim.com.
authors: Andrew V
authors: AV
authors: Fowler
authors: Clinical Development & Medical Affairs/Therapeutic Area Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany. Electronic address: Abhya.Gupta@boehringer-ingelheim.com.
authors: Abhya
authors: A
authors: Gupta
authors: Clinical Development & Medical Affairs/Therapeutic Area Respiratory Diseases, Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany. Electronic address: Kay.Tetzlaff@boehringer-ingelheim.com.
authors: Kay
authors: K
authors: Tetzlaff
authors: Clinical Development & Medical Affairs/Therapeutic Area Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany. Electronic address: Chad.Nivens@boehringer-ingelheim.com.
authors: Michael C
authors: MC
authors: Nivens
authors: Clinical Development & Medical Affairs/Therapeutic Area Respiratory Diseases, Boehringer Ingelheim Ltd., Bracknell, UK. Electronic address: Maria.Sarno@boehringer-ingelheim.com.
authors: Maria
authors: M
authors: Sarno
authors: Clinical Development & Medical Affairs/Therapeutic Area Respiratory Diseases, Boehringer Ingelheim Ltd., Bracknell, UK. Electronic address: Helen.Finnigan.ext@boehringer-ingelheim.com.
authors: Helen A
authors: HA
authors: Finnigan
authors: Department of Medicine, University of Cape Town, Cape Town, South Africa. Electronic address: Eric.Bateman@uct.ac.za.
authors: Eric D
authors: ED
authors: Bateman
authors: National Jewish Health, Denver, CO, USA. Electronic address: SutherlandE@NJHealth.org.
authors: E
authors: E
authors: Rand Sutherland
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001549:Benzamides / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone / Q000008:administration & dosage / Q000627:therapeutic use; D005541:Forced Expiratory Volume; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011743:Pyrimidines / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D011971:Receptors, Immunologic / Q000037:antagonists & inhibitors*; D011982:Receptors, Prostaglandin / Q000037:antagonists & inhibitors*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; C000605880:BI 671800; D001549:Benzamides; D005938:Glucocorticoids; D011743:Pyrimidines; D011971:Receptors, Immunologic; D011982:Receptors, Prostaglandin; D000068298:Fluticasone; C036293:prostaglandin D2 receptor
keywords: Asthma; CRTH2 antagonist; Inhaled corticosteroid