Role of Inflammatory Mediators in AERD

NCT02824523 | Completed DMC

• 1 other identifier: 2016P001164
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

asthma; nasal polyps; aspirin sensitivity; AERD

Outcome Measures

Primary Outcomes (3)

• Therapeutic efficacy of high-dose aspirin as assessed by asthma symptom control (Asthma Control Questionnaire)

  8 weeks

• Therapeutic efficacy of high-dose aspirin as assessed by change in lung function

  8 weeks

• Therapeutic efficacy of high-dose aspirin as assessed by change in sinus symptoms (Sino-Nasal Outcome Test)

  8 weeks

Study Arms (1)

High-dose aspirin

Drug: aspirin

Interventions

aspirin DRUG

High-dose aspirin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with aspirin-exacerbated respiratory disease who are undergoing aspirin desensitization and starting high-dose aspirin therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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.

  PMID: 34820927 DERIVED

• 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.

  PMID: 33781934 DERIVED

MeSH Terms

Conditions

Asthma, Aspirin-Induced; Asthma; Nasal Polyps

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Lung Diseases, Obstructive; Lung Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tanya M Laidlaw, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Katherine C Cahill, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 6, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

US (1)