A phase 2 study to evaluate the safety, efficacy and pharmacokinetics of DP2 antagonist GB001 and to explore biomarkers of airway inflammation in mild‐to‐moderate asthma
| Autor: | Karen Dittrich, Dave Singh, Mary Fitzgerald, Caroline Pattwell, Hector Ortega, Jinshan Shen, Kartik Raghupathi, Cindy-ann Tompkins |
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| Rok vydání: | 2019 |
| Předmět: |
prostaglandin D2
Adult Male 0301 basic medicine medicine.medical_specialty CRTH2 Adolescent Receptors Prostaglandin Immunology eosinophilic asthma Phases of clinical research Placebo Gastroenterology Fluticasone propionate 03 medical and health sciences 0302 clinical medicine Double-Blind Method Pharmacokinetics Internal medicine medicine Humans Immunology and Allergy Anti-Asthmatic Agents Receptors Immunologic Clinical Allergy Prostaglandin D2 receptor business.industry DP2 antagonist Middle Aged Asthma atopic asthma 030104 developmental biology Breath Tests 030228 respiratory system Asthma Control Questionnaire Exhaled nitric oxide Original Article Female ORIGINAL ARTICLES Airway business Biomarkers medicine.drug |
| Zdroj: | Clinical and Experimental Allergy |
| ISSN: | 1365-2222 0954-7894 |
| DOI: | 10.1111/cea.13524 |
| Popis: | Background GB001 is an oral antagonist of the prostaglandin D2 receptor that may inhibit recruitment and activation of airway eosinophils, reducing airway inflammation. Objective To assess GB001 safety, efficacy and pharmacokinetics from a Phase 2 study and explore the association between type 2 biomarkers (fractional exhaled nitric oxide and blood eosinophils) and asthma control markers following GB001 administration. Methods A randomized, placebo‐controlled, double‐blind study evaluating 36 patients with mild‐to‐moderate atopic asthma. Patients receiving fluticasone propionate ≤500 mcg/day or equivalent were randomized (2:1) to GB001 (30 mg) or placebo once daily for 28 days. Safety, pharmacokinetics, forced expiratory volume in 1 second, asthma control questionnaire and rescue medication use were assessed. Clinical outcomes were analysed post hoc by baseline fractional exhaled nitric oxide ( |
| Databáze: | OpenAIRE |
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