Last updated on December 2017

Diagnosis of Aspirin Hypersensitivity by Measuring Arachidonic Acid Metabolites after Low Dose Aspirin Challenge

Brief description of study

Diagnosis of Aspirin Hypersensitivity by Measuring Arachidonic Acid Metabolites after Low Dose Aspirin Challenge

Detailed Study Description

This is a research study of a new approach to diagnose aspirin allergy. Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) is frequently reported by patients requiring aspirin (ASA) for coronary artery disease or NSAIDs for pain management. Even though clinical challenge with relatively high doses of aspirin carries a substantial risk of severe reactions in ASA-hypersensitive population (e.g., bronchospasm), it is used as a gold standard to confirm the diagnosis of ASA hypersensitivity (AH) [1]. A safer, more time and cost efficient test to diagnose ASA-hypersensitivity would be useful.

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 an NSAID.
  • Patients with a history of ASA-tolerant asthma who had been occasionally using NSAID 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).
  • Chronic liver disease by history and/or abnormal liver function tests (SGOT and SGPT above 40 U/L).
  • Baseline FEV1 < 70% (or < 1.5 L) of predicted, or an exacerbation of asthma in the 6 weeks preceding the study.
  • An active infectious disease.
  • Anemia that requires work-up, black stools, active bleeding.
  • A history of gastrointestinal bleeding due to aspirin or other NSAIDS, gastritis, or duodenal ulcer not proven to be due to Helicobacter pylori.
  • A history of hemophilia or any other bleeding disorder.
  • Unstable angina.
  • Participants taking aspirin and or other NSAIDs at the time of the study enrollment.
  • Participants taking leukotriene receptors inhibitors or 5-LO inhibitors at the time of the study enrollment.
  • In addition, participants taking one or more of the following drugs intake last 14 days prior to the enrollment will be excluded: lithium, warfarine, enoxaparin, heparin, dalteparin, fluconazole, ketotifen. Short-acting antihistamines will be stopped 5 days before the challenge; long-acting antihistamines will be stopped 1 week prior to the challenge.

Clinical Study Identifier: TX134849

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Einstein-Montefiore Institute for Clinical and Translational Research

Albert Einstein College of Medicine/Montefiore Medical Center<br /> 1515 Blondell Ave., Suite 220 Bronx, NY USA
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Recruitment Status: Open

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