Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease (NCT01320072) | Clinical Trial Compass
TerminatedNot Applicable
Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease
Stopped: Study discontinued and closed out by IRB. PI left the institution.
United States29 participantsStarted 2010-05
Plain-language summary
To diagnose aspirin hypersensitivity in asthmatics by using and safe, low-dose aspirin oral challenge.
Hypothesis 1: A low dose of oral ASA (20 or 40 mg) will induce significantly different concentrations of arachidonic acid metabolites in ASA-sensitive asthmatics as compared to ASA-tolerant asthmatics.
Hypothesis 2: The low dose (20 or 40 mg) ASA challenge will be well tolerated by ASA-sensitive asthmatics.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Participants of both sexes aged 18 years and older.
✓. Patients with a history of ASA-induced asthma who had at least one asthma attack after ingestion of aspirin or other NSAIDs.
✓. Patients with a history of ASA-tolerant asthma who had been occasionally using aspirin or other NSAIDs without any adverse reactions.
Exclusion criteria
✕. Mental or legal incapacitation, or significant emotional problems, or a history of psychiatric disorders at the time of the enrollment.
✕. Pregnancy or breastfeeding at the time of enrollment.
✕. History of a severe anaphylactic reaction precipitated by ASA and/or other NSAIDs (such as ibuprofen, naproxen, indomethacin, Advil, Aleve, Motrin, diclofenac, etc.).
✕. History of a severe bronchospasm precipitated by ASA and/or other NSAIDs requiring an endotracheal intubation.
✕. Chronic kidney disease (a calculated GFR based on the Modification of Diet in Renal Disease (MDRD) equation is \< 60 mL/min/1.73 sq.meter).