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- W1922210558 abstract "Background: Bimosiamose a pan-selectin antagonist, previously attenuated ozone-induced airway-inflammation in healthy volunteers. Here we investigated the safety and efficacy of Bimosiamose in a cross-over, double-blind, randomized, placebo-controlled, multi-center trial in patients with COPD.Methods: 77 moderate to severe COPD patients (GOLD II-III) were enrolled. Bimosiamose (10 mg) or placebo was inhaled by the breath actuated nebulizer Akita2 Apixneb™ for 28 days twice daily on top of standard bronchodilator therapy. Efficacy was assessed by cellular and non-cellular parameters in induced sputum at baseline and day 28 of both treatment periods. Lung function (FEV1, FVC, PEF, IC) was measured by standardized spirometry.Results: The total AE ratio of Bimosiamose compared to placebo treatment was balanced. In induced sputum, as compared to placebo, treatment with Bimosiamose led to a reduction of absolute numbers of non-squamous cells (-23%), neutrophils (-24%), lymphocytes (-44%), eosinophils (-34%) and macrophages (-49%), IL-8 (-27%), MMP-9 (-16%) and MPO (-7%). Treatment difference was statistically significant for IL-8 (p=0.009) and macrophages (p=0.012). Compared to baseline, Bimosiamose improved FEV1 by 50 mL (-15 to 115; 95%CI) and IC by 117 ml (11 to 222; 95%CI) at day 28. Treatment difference was statistically significant for FVC (p=0.036).Conclusions: Inhalation of Bimosiamose for 28 days was safe and well tolerated. It led to an attenuation of airway inflammation and trend towards lung function improvements. These findings support the potential of Bimosiamose as a new anti-inflammatory therapy for COPD." @default.
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- W1922210558 date "2011-09-01" @default.
- W1922210558 modified "2023-09-28" @default.
- W1922210558 title "Late-breaking abstract: Inhaled pan-selectin antagonist bimosiamose in COPD: A double-blind, randomized, placebo-controlled phase II study" @default.
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