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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Montefiore Medical Center
Information provided by (Responsible Party):
Elina Jerschow, Montefiore Medical Center
ClinicalTrials.gov Identifier:
First received: March 17, 2011
Last updated: September 22, 2015
Last verified: September 2015

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.

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:
  • Number of Participants With Treatment-Related Adverse Events as Assessed by change in forced expiratory volume in 1 second (FEV1) and by the presence of adverse reactions, such as upper and/or lower respirtory symptoms, GI symptoms, or skin rash [ Time Frame: 24 hours after the challenge ] [ Designated as safety issue: Yes ]
    FEV1 will be assessed at baseline and after aspirin challenges, changes in FEV1 will be recorded. The adverse reactions will be assessed by symptom questionnaires

Estimated Enrollment: 26
Study Start Date: May 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Aspirin-sensitive asthmatics
aspirin-tolerant asthmatics


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320072

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: Elina Jerschow, Attending physician, 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: September 22, 2015
Health Authority: United States: Institutional Review Board
United States: Department of Health and Human Services

Keywords provided by Montefiore Medical Center:

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

ClinicalTrials.gov processed this record on February 04, 2016