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Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma, Aspirin-Induced; Aspirin Exacerbated Asthma

Intervention: Prasugrel (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Elliot Israel, MD

Official(s) and/or principal investigator(s):
Elliot Israel, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital
Joshua Boyce, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital

Overall contact:
Jillian Bensko, Phone: 617-732-6641, Email: jbensko@partners.org

Summary

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.

Clinical Details

Official title: Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Primary outcome:

Change in Total Nasal Symptom Score(TNSS)from baseline to aspirin challenge/desensitization.

Change from baseline expression levels of COX-2 transcript and protein in peripheral blood leukocytes of subjects with AERD after 8 weeks of treatment with aspirin.

Secondary outcome:

Difference in participant's provocative dose of aspirin when pretreated with prasugrel versus placebo

Change in urinary LTE4

Effect desensitization to and treatment with aspirin has on baseline characteristics of AERD

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Jillian Bensko, Phone: 617-732-6641, Email: jbensko@partners.org

Asthma Research Center, Boston, Massachusetts 02115, United States; Recruiting
Jillian Bensko, Phone: 617-732-6641, Email: jbensko@partners.org
Elliot Israel, MD, Principal Investigator
Additional Information

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Starting date: August 2012
Last updated: February 18, 2015

Page last updated: August 20, 2015

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