Efficacy of an oral CRTH2 antagonist (AZD1981) in the treatment of chronic rhinosinusitis with nasal polyps in adults: A randomized controlled clinical trial

Caroline P.E. Price, Amina Guo, Whitney W. Stevens, Leslie Cousens, Thanh Huyen T. Vu, Lydia A. Suh, Kristin A. Erickson, David Conley, Leslie C. Grammer, Robert C. Kern, Bruce K. Tan, Atsushi Kato, Robert P. Schleimer, Stephanie S. Smith, Kevin C. Welch, Anju T. Peters*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2 inflammatory disease of the upper airways. AZD1981 is a selective antagonist of chemoattractant receptor-homologous molecule expressed on T helper type 2 and other type 2 cells, including innate lymphoid cells type 2, eosinophils, and basophils. Objective: To evaluate the efficacy of AZD1981 in reducing nasal polyp size when added to intranasal corticosteroids in adult patients with CRSwNP. Methods: Eighty-one subjects (18–70 years of age) with CRSwNP were recruited and screened for trial eligibility from allergy and otolaryngology clinics from a single tertiary care site between June 2016 and August 2019. Eligible patients were randomized in a double-blind fashion to receive either AZD1981 (n = 22) or placebo (n = 21) orally three times a day for 12 weeks, added to intranasal corticosteroids. The primary endpoint was a change in nasal polyp score (NPS) at 12 weeks. Secondary endpoints included improvement in sinus computed tomography using Lund Mackay scoring, symptoms using visual analog scale, quality of life using Sino Nasal Outcome Test-22, and the Brief Smell Identification Test. Results: Forty-three patients met the inclusion criteria and were enrolled. At 12 weeks, there was no difference in NPS change in the AZD1981 arm (mean 0, standard error 0.34, n = 15) compared with placebo (mean 0.20, standard error 0.36, n = 17); mean difference −0.20 (95% confidence interval: −1.21, 0.81; p =.69). No significant differences were observed for Lund Mackay score, symptoms, quality of life, or smell test. AZD1981 was well tolerated except for one case of hypersensitivity reaction. Conclusion: In patients with CRSwNP, the addition of AZD1981 to intranasal corticosteroids did not change nasal polyp size, radiographic scores, symptoms, or disease-specific quality of life.

Original languageEnglish (US)
Pages (from-to)859-867
Number of pages9
JournalClinical and Experimental Allergy
Volume52
Issue number7
DOIs
StatePublished - Jul 2022

Keywords

  • AZD1981
  • CRTH2 antagonist
  • nasal polyps
  • rhinosinusitis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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