Role of Inflammatory Mediators in AERD

NCT ID: NCT02824523

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-05-01

Brief Summary

The purpose of this research study is to learn new information about the underlying cause of aspirin-exacerbated respiratory disease (AERD) and the benefit of high-dose aspirin therapy. AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs. This study will be conducted on individuals with AERD who are referred to the Brigham and Women's Hospital AERD Center for clinical evaluation and potential aspirin desensitization. Desensitization to aspirin and subsequent treatment with daily high-dose oral aspirin is standard of care for patients with AERD who do not respond adequately to steroids and have recurrent nasal polyposis or symptomatic asthma. This study will involve five visits to Brigham and Women's Hospital and will align closely with the standard of care for the treatment of AERD.

Conditions

Asthma, Aspirin-Induced

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

High-dose aspirin

aspirin

Intervention Type: DRUG

Interventions

aspirin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• History of asthma
• History of nasal polyposis
• History of at least one clinical reaction to oral aspirin or other nonselective COX inhibitor with features of both lower (cough, chest tightness, wheezing, dyspnea) and upper (rhinorrhea, sneezing, nasal obstruction, conjunctival itching and discharge) airway involvement
• Stable asthma (post-bronchodilator FEV1 of ≥70%, no use of oral or systemic steroids for at least 1 month, and no hospitalizations or emergency room visits for asthma for the prior 6 months) at the time of entry into the study
• Currently taking montelukast as part of standard asthma treatment for at least 4 weeks before the V1 visit

Exclusion Criteria

• Pregnancy or current breastfeeding
• History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
• History of thrombocytopenia < 50 x 10^9/L
• Hypersensitivity to montelukast
• Peptic ulcer disease
• Unstable asthma (post-bronchodilator FEV1 of less than 70%, use of oral or systemic steroids for at least 1 month prior to visit 1, or hospitalizations or emergency room visits for asthma for the prior 6 months)
• Use of zileuton (which can mask symptoms of aspirin-induced reaction) within 1 month prior to the V1 visit
• Age under 18 or over 75 years
• Current smoking

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tanya Laidlaw, MD

Associate Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tanya M Laidlaw, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Katherine C Cahill, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Patel PP, Cui J, Cahill KN, Laidlaw TM. Objective validity of patient-reported symptoms in aspirin-exacerbated respiratory disease patients. Clin Exp Allergy. 2022 Feb;52(2):348-351. doi: 10.1111/cea.14062. Epub 2021 Dec 1. No abstract available.

Reference Type: DERIVED

PMID: 34820927 (View on PubMed)

Staso PJ, Wu P, Laidlaw TM, Cahill KN. Scoring tool for systemic symptoms during aspirin challenge detects mediator production in aspirin-exacerbated respiratory disease. Ann Allergy Asthma Immunol. 2021 Jul;127(1):131-133. doi: 10.1016/j.anai.2021.03.025. Epub 2021 Mar 27. No abstract available.

Reference Type: DERIVED

PMID: 33781934 (View on PubMed)

Other Identifiers

2016P001164

Identifier Type: -

Identifier Source: org_study_id