Immune Changes in Chronic Rhinosinusitis with Nasal Polyps and Aspirin Sensitivity After Aspirin Desensitization

Overview

About this study

The objectives of this study are to determine longitudinal effects of aspirin desensitization on circulating immune cells in Aspirin Exacerbated Respiratory Disease (AERD) subjects, and to compare effects of sinus surgery on circulating immune cells in patients with AERD compared to patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Immune cells in nasal polyp tissue removed at the time of endoscopic sinus surgery will also be compared to the profile of circulating immune cells before and after endoscopic sinus surgery and, for some subjects, after aspirin desensitization.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - CRSwNP:

  • Age 18 years and older.
  • Both males and females.
  • Meet clinical definition of CRS which is 12 weeks with at least 2 of the major criteria for diagnosis within the past 24 months (nasal discharge, nasal obstruction, facial congestion, facial pain-pressure-fullness or decrease in sense of smell).
  • Presence of nasal polyps as evidenced by a CT scan or rhinoscopy.

 Inclusion Criteria - wsf AERD aspirin desensitization

  • Age 18 years and older.
  • Both males and females.
  • Be Aspirin sensitive (AERD)
  • AERD - Meet clinical definition of aspirin exacerbated respiratory disease as identified through clinical history and/or prior positive aspirin intolerance and scheduled to undergo an aspirin challenge and desensitization in the allergic diseases clinical laboratory.

Inclusion Criteria - AERD non-Aspirin desensitization:

  • Age 18 years and older.
  • Both males and females.
  • Meet clinical definition of aspirin exacerbated respiratory disease as identified through clinical history and/or prior positive aspirin intolerance.
  • Contraindication to Aspirin therapy or by patient choice.

Exclusion Criteria - All Groups:

  • Cystic fibrosis.
  • Known pregnancy at the time of appointment.
  • Cigarette smoking in the last 6 months.
  • Common Variable Immunodeficiency Disease.
  • EGPA or small vessel vasculitis.
  • Primary ciliary dyskinesia.
  • Primary immune deficiency disorder.
  • Oral corticosteroids in the past 2 weeks before visit.
  • Intramuscular corticosteroids in the past 6 weeks before visit.
  • Current cancer treatment with immunotherapy and chemotherapy.
  • Treatment with biologics at the time of enrollment.
  • Zileuton.

Eligibility last updated 12/20/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Erin O'Brien, M.D.

Closed for enrollment

Contact information:

Danielle Hunter

(507) 266-4539

Hunter.Danielle@mayo.edu

More information

Publications

Publications are currently not available