Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)
| Status: | Completed |
|---|---|
| Conditions: | Asthma, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 7/26/2018 |
| Start Date: | August 31, 2012 |
| End Date: | December 14, 2016 |
The investigators are doing this research study to find out if giving a drug called
prasugrel, which is used to prevent blood clots, can reduce reactions to aspirin in people
with aspirin exacerbated respiratory disease (AERD), and to learn why taking aspirin every
day can work as a treatment for people with AERD. People with AERD have symptoms of asthma,
severe runny nose, polyps in the nose, and develop allergic reactions if they take
medications like aspirin.
People with AERD can be desensitized to aspirin in order to be able to safely use it daily,
but the investigators do not know if prasugrel may prevent reactions to aspirin and provide a
safer way for people with AERD to tolerate aspirin.
The investigators also want to understand what is different about the cells and urine from
subjects who have AERD, in comparison to subjects who have asthma but do not have AERD and
subjects who have allergic rhinitis but do not have asthma. Lastly, the investigators want to
understand how aspirin acts differently in subjects who have AERD, in comparison to subjects
who have asthma but do not have AERD.
prasugrel, which is used to prevent blood clots, can reduce reactions to aspirin in people
with aspirin exacerbated respiratory disease (AERD), and to learn why taking aspirin every
day can work as a treatment for people with AERD. People with AERD have symptoms of asthma,
severe runny nose, polyps in the nose, and develop allergic reactions if they take
medications like aspirin.
People with AERD can be desensitized to aspirin in order to be able to safely use it daily,
but the investigators do not know if prasugrel may prevent reactions to aspirin and provide a
safer way for people with AERD to tolerate aspirin.
The investigators also want to understand what is different about the cells and urine from
subjects who have AERD, in comparison to subjects who have asthma but do not have AERD and
subjects who have allergic rhinitis but do not have asthma. Lastly, the investigators want to
understand how aspirin acts differently in subjects who have AERD, in comparison to subjects
who have asthma but do not have AERD.
Inclusion Criteria for Participants with AERD:
- History of physician-diagnosed 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% or better, no increase in baseline dose
of oral glucocorticoids for at least 3 months, and no history of hospitalization or
emergency room visits for asthma for at least the prior 6 months).
- No current smoking, defined as no daily tobacco smoking for at least 6 months and not
more than one instance of tobacco smoking in the last 3 months.
- Non-pregnant
- Only those individuals who would otherwise meet clinical qualifications for aspirin
desensitization and treatment with high-dose aspirin will be considered for enrollment
in the study.
Inclusion Criteria for Participants who are Aspirin Tolerant Asthmatics:
- History of physician-diagnosed asthma.
- No current nasal polyposis confirmed by nasal examination.
- No history of any adverse reaction to aspirin or a COX inhibitor.
- Stable asthma (post-bronchodilator FEV1 of 70% or better, no increase in baseline dose
of oral glucocorticoids for at least 3 months, and no history of hospitalization or
emergency room visits for asthma for at least the prior 6 months).
- No current smoking
- Non-pregnant
Inclusion Criteria for Non Asthmatics with Allergic Rhinitis:
- No history of physician-diagnosed asthma.
- No current nasal polyposis confirmed by nasal examination.
- No history of any adverse reaction to aspirin or a COX inhibitor.
- No current smoking
- Non-pregnant
- Clinical history of symptoms consistent with allergic rhinitis and previously
documented allergy to at least one environmental,immunoglobulin E (IgE) testing).
- Normal lung function (baseline FEV1 of 80% of predicted or better).
- A score of 4 or below on the Asthma Screening Questionnaire (33) and negative
responses to asthma history questions
Exclusion Criteria for participants with AERD:
- Current breastfeeding
- History of bleeding diathesis or current use of anticoagulant or antiplatelet drugs
- Hypersensitivity to montelukast or thienopyridines
- History of peptic ulcer disease or gastrointestinal bleed
- Current severe gastro-esophageal reflux disease (GERD), defined as patient currently
requiring more than 2 total doses of medication per day to treat persistent symptoms:
either more than 2 doses of any single medication type (antacid, proton pump
inhibitor, or H2 receptor antagonist), or more than 2 types of medication per day to
treat symptoms
- History of systemic or life-threatening respiratory reaction to aspirin requiring
intubation or administration of adrenalin
- Current use of any oral beta blocker (due to the risk of bronchospasm associated with
beta blockers).
- History of transient ischemic attack or stroke, or diabetes.
- Current presence of uncontrolled hypertension.
- History of hepatic impairment or alcoholism, or evidence of abnormal liver function at
Screening Visit. Aspartate transaminase (AST) and alanine transaminase (ALT) levels
may not exceed 1.5x the upper limit of normal at Screening Visit (AST may not exceed
52 IU/L, ALT may not exceed 78 IU/L).
Exclusion Criteria for Participants with Aspirin Tolerant Asthma and Non Asthmatics with
Allergic Rhinitis:
- Current breastfeeding
- History of bleeding diathesis or current use of anticoagulant or antiplatelet drugs
- Hypersensitivity to montelukast or thienopyridines
- History of peptic ulcer disease or gastrointestinal bleed
- Current severe GERD
- Current use of any oral beta blocker.
We found this trial at
1
site
Boston, Massachusetts 02115
Principal Investigator: Elliot Israel, MD
Phone: 617-732-6641
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