RECRUITING

Mechanisms of Dupilumab in AERD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Aspirin-Exacerbated Respiratory Disease (AERD), although uncommon in the general population, is an important phenotype of severe asthma and nasal polyposis where it occurs in 15% of severe asthmatics, and up to 30% of those with nasal polyposis. An important therapy for AERD is aspirin therapy after desensitization (ADAT). This is an inexpensive and proven therapy to improve the burden of sinus disease in AERD. Aspirin desensitization is the mechanism by which tolerance is induced in AERD patients. This is a 1-2 day outpatient procedure whereby increasing doses of aspirin are administered and the patients invariably experience some degree of hypersensitivity reactions. It is important to understand the effect of medications on the aspirin desensitization. It is known that the leukotriene modifier medications decrease the severity of the reactions in AERD. Other treatments such as antihistamines and the biologic agent omalizumab might have an effect on either blocking or blunting reactivity in AERD during desensitization. Dupilumab is a new respiratory biologic approved for atopic dermatitis, eosinophilic asthma and nasal polyposis. As such, it is well situated to be used for many AERD patients whose disease cannot be well controlled. The effect of dupilumab on the aspirin desensitization process and reaction is unknown and is the topic of this investigation. The primary objective is to determine the effect of dupilumab on reactions during aspirin challenge/desensitization.

Official Title

Mechanisms of Dupilumab in AERD - Effects on Aspirin Hypersensitivity Response, With a Focus on Innate Type 2 Inflammatory Responses

Quick Facts

Study Start:2024-03-25
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05031455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects \>18 years old with Aspirin-Exacerbated Respiratory Disease
  2. * Current treatment with dupilumab at standard asthma/nasal polyposis dosing of 300mg subcutaneously every 2 weeks for a minimum of 12 weeks.
  3. * All subjects will be required to have a known history of nasal polyposis either via imaging, endoscopy, or nasal examination
  1. * History of gastrointestinal reactions (severe abdominal pain with or without vomiting) during NSAID triggered events
  2. * Unstable asthma or history of severe reactions during previous desensitization attempts
  3. * inability to take montelukast pretreatment
  4. * history of gastrointestinal bleeding or bleeding disorder
  5. * pregnancy
  6. * previous use of any other respiratory biologic in the past 3 months (omalizumab, tezepelumab, mepolizumab, reslizumab, benralizumab)
  7. * need for systemic corticosteroids to stabilize asthma prior to challenge
  8. * time from sinus surgery \<1 month.

Contacts and Locations

Study Contact

Andrew White, MD
CONTACT
858-764-9010
white.andrew@scrippshealth.org

Study Locations (Sites)

Scripps Clini
San Diego, California, 92130
United States

Collaborators and Investigators

Sponsor: Scripps Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-25
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2024-03-25
Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Aspirin-exacerbated Respiratory Disease