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 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.

Rating:

Share or cite this content

Citations should be made in the following way:
A. Fowler, D. Miller, C. LaForce, A. Finn, E. Bateman, K. Drda, J. Blatchford, W. Broderick, A. Gupta, C. Wood (North Dartmouth, Raleigh, North Charleston, Ridgefield, United States Of America; Cape Town, South Africa; Bracknell, United Kingdom; Biberach an der Riss, Germany). Efficacy and safety of BI 671800, an oral CRTH2 antagonist, as add on therapy in poorly controlled asthma patients prescribed an inhaled corticosteroid. Eur Respir J 2012; 40: Suppl. 56, 3085

Member's Comments

No comment yet.

Related content which might interest you: First line maintenance therapy for asthma: an observational study comparing inhaled corticosteroid monotherapy to combination inhaled corticosteroid/long acting beta agonist therapy in UK general practice Source: Annual Congress 2007 - Traditional and novel approaches to assess and achieve asthma control Year: 2007 Step-up of asthma therapy: an observational study comparing increased inhaled corticosteroid dosage to combination inhaled corticosteroid/long acting beta agonist therapy in UK general practice Source: Annual Congress 2007 - Traditional and novel approaches to assess and achieve asthma control Year: 2007 Efficacy and safety of BI 671800, an oral CRTH2 antagonist in controller naïve patients with poorly-controlled asthma Source: Annual Congress 2012 - New bronchodilators and other novel drugs for asthma and COPD Year: 2012 The safety and tolerability of twice-daily oral doses of AZD5069, a novel CXCR2 antagonist, in patients with moderate-to-severe COPD Source: Annual Congress 2012 - New bronchodilators and other novel drugs for asthma and COPD Year: 2012 Should guidelines be revised for add-on therapy in asthma? A 2 year randomized pragmatic equivalence trial of leukotriene antagonists (LTRAs) and long-acting beta agonists (LABAs) with inhaled corticosteroids (ICS) in primary care Source: Annual Congress 2008 - Wider aspects of managing respiratory disease in primary care Year: 2008 Efficacy and safety of as-needed corticosteroid plus fast or short-acting beta-agonists monotherapy in patients with mild asthma: a meta-analysis of randomised controlled trials. Source: Virtual Congress 2020 – Inhaled corticosteroids and bronchodilator studies in asthma Year: 2020 Impact of the combination therapy: inhaled corticosteroid and long-acting beta agonists in the prescription pattern of inhaled corticosteroids Source: Annual Congress 2007 - Respiratory issues in primary care Year: 2007 Long-acting β2-agonists provide greater benefit compared to leukotriene antagonists when added to inhaled corticosteroids in patients with symptomatic asthma Source: Eur Respir J 2004; 24: Suppl. 48, 310s Year: 2004 The impact of tiotropium on mortality when added to inhaled corticosteroids and long-acting beta agonist therapy in COPD Source: Annual Congress 2011 - Bronchodilators in asthma and COPD Year: 2011 Efficacy and safety of high-dose inhaled corticosteroids therapy in children with asthma Source: Annual Congress 2010 - Allergy and risk factors in paediatrics Year: 2010 Efficacy and safety of AZD3199, an inhaled ultra long-acting β2-agonist, in patients with COPD Source: Annual Congress 2011 - Bronchodilators in asthma and COPD Year: 2011 Tolerability and efficacy of inhaled AZD4818, a CCR1 antagonist, in moderate to severe COPD patients Source: Annual Congress 2009 - New drugs for airways disease Year: 2009 Budesonide/formoterol reduces the use of oral corticosteroids in the treatment of COPD Source: Eur Respir J 2003; 22: Suppl. 45, 50s Year: 2003 Comparison of asthma treatment given in addition to inhaled corticosteroids on airway inflammation and responsiveness Source: Eur Respir J 2006; 27: 1144-1151 Year: 2006 One-year pulmonary safety and efficacy of inhaled insulin as adjunctive therapy in type 2 diabetes patients poorly controlled on oral agent monotherapy Source: Eur Respir J 2004; 24: Suppl. 48, 618s Year: 2004 24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids}, Source: Eur Respir J 2012; 40: 570-579 Year: 2012 Efficacy of indacaterol in COPD is maintained irrespective of inhaled corticosteroid (ICS) use Source: Annual Congress 2011 - Bronchodilators in asthma and COPD Year: 2011 Safety of formoterol reliever therapy compared with terbutaline in asthmatic children taking anti-inflammatory therapy Source: Eur Respir J 2002; 20: Suppl. 38, 431s Year: 2002 Real-life use and impact of inhaled steroids (ICS) and leukotriene receptor antagonists (LTRA) monotherapy in children with asthma Source: Annual Congress 2010 - Paediatric asthma treatment and monitoring Year: 2010 Efficacy of long-term formoterol therapy vs as-needed salbutamol use in patients with moderate asthma Source: Eur Respir J 2001; 18: Suppl. 33, 426s Year: 2001