Role of Inflammatory Mediators in AERD
Role of Inflammatory Mediators in AERD
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.
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