Role of Inflammatory Mediators in AERD
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 1/18/2019 |
| Start Date: | July 2016 |
| End Date: | May 2021 |
| Contact: | Joseph Singer |
| Email: | jsinger3@partners.org |
| Phone: | 617-525-1284 |
Role of PDG2 in the Aspirin-Induced Reactions and in the Treatment of Aspirin-Exacerbated Respiratory Disease
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.
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.
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
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-525-1267
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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