Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease (ASAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Montefiore Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01320072
First received: March 17, 2011
Last updated: March 18, 2011
Last verified: March 2011
  Purpose

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.


Condition
Aspirin Exacerbated Respiratory Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease Using a Safe, Low Dose Aspirin Challenge

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • eicosanoid metabolites concentration in plasma and urine [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    collection of the specimens after 2 h post ASA challenge


Secondary Outcome Measures:
  • safety and tolerability of the low dose aspirin challenge [ Time Frame: 24 hours after the challenge ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: May 2010
Groups/Cohorts
Aspirin-sensitive asthmatics
aspirin-tolerant asthmatics

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Allergy/Immunology clinic population in Bronx, NY

Criteria

Inclusion Criteria:

  1. Participants of both sexes aged 18 years and older.
  2. Patients with a history of ASA-induced asthma who had at least one asthma attack after ingestion of aspirin or other NSAIDs.
  3. Patients with a history of ASA-tolerant asthma who had been occasionally using aspirin or other NSAIDs without any adverse reactions.

Exclusion Criteria:

  1. Mental or legal incapacitation, or significant emotional problems, or a history of psychiatric disorders at the time of the enrollment.
  2. Pregnancy or breastfeeding at the time of enrollment.
  3. History of a severe anaphylactic reaction precipitated by ASA and/or other NSAIDs (such as ibuprofen, naproxen, indomethacin, Advil, Aleve, Motrin, diclofenac, etc.).
  4. History of a severe bronchospasm precipitated by ASA and/or other NSAIDs requiring an endotracheal intubation.
  5. 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).
  6. Chronic liver disease by history and/or abnormal liver function tests (SGOT and SGPT ≥ 3 times above upper normal range).
  7. Baseline FEV1 < 70% (or < 1.5 L) of predicted, or an exacerbation of asthma in the 6 weeks preceding the study.
  8. An active infectious disease.
  9. Anemia that requires work-up, black stools, active bleeding.
  10. A history of gastrointestinal bleeding due to aspirin or other NSAIDS, gastritis, or duodenal ulcer not proven to be due to Helicobacter pylori.
  11. A history of hemophilia or any other bleeding disorder.
  12. Unstable angina.
  13. Participants taking aspirin and or other NSAIDs at the time of the study visits.
  14. Participants taking leukotriene receptors inhibitors or 5-lypooxygenase (5-LO) inhibitors at the time of the study visits.
  15. 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 should be stopped 5 days before the challenge; long-acting antihistamines should be stopped 1 week prior to the challenge.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01320072

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Elina Jerschow, MD    917-362-5291    elina.jerschow@einstein.yu.edu   
Principal Investigator: Elina Jerschow, MD         
Sponsors and Collaborators
Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Dr. Elina Jerschow, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01320072     History of Changes
Other Study ID Numbers: 10-01-002
Study First Received: March 17, 2011
Last Updated: March 18, 2011
Health Authority: United States: Institutional Review Board
United States: Department of Health and Human Services

Keywords provided by Montefiore Medical Center:
aspirin
asthma
diagnosis
prostaglandins
leukotrienes

Additional relevant MeSH terms:
Aspirin
Hypersensitivity
Respiration Disorders
Respiratory Tract Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014