Clinical Research Needs for the Management of Chronic Rhinosinusitis with Nasal Polyps in the New Era of Biologics: A National Institute of Allergy and Infectious Diseases Workshop

J Allergy Clin Immunol Pract. 2020 May;8(5):1532-1549.e1. doi: 10.1016/j.jaip.2020.02.023. Epub 2020 Mar 4.


The development of biologics targeting various aspects of type 2 inflammation for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) will provide clinicians with powerful tools to help treat these patients. However, other therapies are also available, and positioning of biologics in a management algorithm will require comparative trials. In November 2019, the National Institute of Allergy and Infectious Diseases convened a workshop to consider potential future trial designs. Workshop participants represented a wide spectrum of clinical specialties, including otolaryngology, allergy, and pulmonary medicine, as well as expertise in CRSwNP pathophysiology and in trial methodology and statistics. The workshop discussed the current state of knowledge in CRSwNP and considered the advantages and disadvantages of various clinical trial or observational study designs and various clinical outcomes. The output from this workshop, which is presented in this report, will hopefully provide investigators with adequate information and ideas to design future studies and answer critical clinical questions. It will also help clinicians understand the current state of the management of CRSwNP and its gaps and be more able to interpret the new information to come.

Keywords: Clinical trials; Dupilumab; Mepolizumab; Nasal polyposis; Omalizumab; Outcomes; Rhinosinusitis; Type 2 inflammation.

Publication types

  • Review

MeSH terms

  • Biological Products* / therapeutic use
  • Chronic Disease
  • Clinical Trials as Topic
  • Humans
  • Nasal Polyps* / therapy
  • National Institute of Allergy and Infectious Diseases (U.S.)
  • Observational Studies as Topic
  • Rhinitis* / drug therapy
  • Sinusitis* / drug therapy
  • United States


  • Biological Products