Clinical Trial: Role of Inflammatory Mediators in AERD
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Role of PDG2 in the Aspirin-Induced Reactions and in the Treatment of Aspirin-Exacerbated Respiratory Disease
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 four visits to Brigham and Women's Hospital and will align closely with the standard of care for the treatment of AERD.
Detailed Summary:
Sponsor: Brigham and Women's Hospital
Current Primary Outcome:
- Therapeutic efficacy of high-dose aspirin as assessed by asthma symptom control (Asthma Control Questionnaire) [ Time Frame: 8 weeks ]
- Therapeutic efficacy of high-dose aspirin as assessed by change in lung function [ Time Frame: 8 weeks ]
- Therapeutic efficacy of high-dose aspirin as assessed by change in sinus symptoms (Sino-Nasal Outcome Test) [ Time Frame: 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Brigham and Women's Hospital
Dates:
Date Received: June 24, 2016
Date Started: July 2016
Date Completion:
Last Updated: July 1, 2016
Last Verified: July 2016
