Role of Inflammatory Mediators in AERD

Asthma, Aspirin-Induced Clinical Trial

Official title:

Role of PDG2 in the Aspirin-Induced Reactions and in the Treatment of Aspirin-Exacerbated Respiratory Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824523
• Other study ID #: 2016P001164
• Status: Completed
• Start date: July 2016
• Est. completion date: May 1, 2021

Study information

• Verified date: September 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma, Aspirin-Induced

Intervention

Drug:
• aspirin

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic efficacy of high-dose aspirin as assessed by asthma symptom control (Asthma Control Questionnaire)		8 weeks
Primary	Therapeutic efficacy of high-dose aspirin as assessed by change in lung function		8 weeks
Primary	Therapeutic efficacy of high-dose aspirin as assessed by change in sinus symptoms (Sino-Nasal Outcome Test)		8 weeks