Efficacy and safety of the CRTh2 antagonist AZD1981 as add-on therapy to inhaled corticosteroids and long-acting β2 -agonists in patients with atopic asthma

Drug Design, Development and Therapy
Eric D BatemanMohib Uddin

Abstract

To evaluate the efficacy and safety of AZD1981, a potent, specific antagonist of the CRTh2 receptor, as add-on therapy to inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA), in patients with persistent asthma with an allergic component. In this placebo-controlled, parallel-group Phase IIb study, patients with persistent atopic asthma on ICS and LABA were randomized to receive 12 weeks of treatment with placebo or AZD1981 (80 mg daily, 200 mg daily, and 10 mg, 40 mg, 100 mg, or 400 mg twice daily [BID]). The primary end point was the mean change from baseline in predose, prebronchodilator forced expiratory volume in 1 second (FEV1) averaged over weeks 2, 4, 8, and 12 in the AZD1981-treatment group vs the placebo group. Secondary end points included other measures of lung function, symptoms, and asthma control, as well as standard measures of safety. In total, 1,140 patients (99.7%) received study treatment. There were improvements in the primary end point across all treatment groups over 12 weeks of treatment. However, the improvement for the highest AZD1981 dose (400 mg BID) vs placebo was not statistically significant (0.02 L, P=0.58), preventing interpretation of statistical testing for the lower doses. AZD1981 ...Continue Reading

Citations

Dec 6, 2018·Current Opinion in Allergy and Clinical Immunology·Anne-Charlotte JonckheereSven F Seys
Jul 14, 2019·Clinical Reviews in Allergy & Immunology·Vivian Aranez, Julian Ambrus
Jul 31, 2019·Clinical Reviews in Allergy & Immunology·Daniel Hamilton, Heather Lehman
Nov 27, 2019·Pharmacological Reviews·Stacy Gelhaus WendellCheng Zhang
Jul 7, 2018·Frontiers in Immunology·Selene BaosBlanca Cárdaba
Oct 8, 2021·Clinical and Experimental Allergy : Journal of the British Society for Allergy and Clinical Immunology·Dorian HassounLuc Colas
Mar 18, 2019·International Archives of Allergy and Immunology·Eric Tyrell OliverSarbjit Singh Saini

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Methods Mentioned

BETA
contraception

Clinical Trials Mentioned

NCT01197794

Software Mentioned

GRand

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