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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01320072
Recruitment Status : Active, not recruiting
First Posted : March 22, 2011
Results First Posted : April 5, 2016
Last Update Posted : November 25, 2020
Information provided by (Responsible Party):
Elina Jerschow, Montefiore Medical Center

Brief 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.

Condition or disease
Asthma, Aspirin-induced

Detailed Description:

This research study is being conducted within the established Airway Research Group at Montefiore Medical Center and Albert Einstein College of Medicine in Bronx, NY. The patient population in the Bronx has one of the highest asthma prevalences in the country. Thus, our study participants are being recruited among the population most in need of a better understanding of the disease process.

Visits 1 and 2: Low-dose challenge with 20 mg and 40 mg of ASA. ASA will be administered orally to participants in both groups: 20 mg at Visit 1 and 40 mg at Visit 2. Visits will take place at least 1 week apart. Blood and urine will be collected at several time points.

Visit 3: Oral graded ASA challenge will be performed to confirm or rule out the presence of ASA-hypersensitivity. This visit will take place at least 1 week after Visit 2. Both groups will undergo an oral graded ASA challenge as per earlier described protocol. Urine and plasma will be collected from the patients at several time points. Hypersensitivity reactions will be defined in four different ways: a) decline in forced expiratory volume in 1 second (FEV1) of at least 15% combined and naso-ocular reaction; b) 20% decline in FEV1; c) isolated naso-ocular reactions; d) isolated cutaneous reactions (hives and swelling). Patients with reactions will be treated according to their symptoms.

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Study Type : Observational
Actual Enrollment : 29 participants
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
Actual Study Start Date : May 2010
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Asthma
Drug Information available for: Aspirin

Aspirin-sensitive asthmatics
asthma patients with aspirin allergy
aspirin-tolerant asthmatics
asthma patients without aspirin allergy

Primary Outcome Measures :
  1. Eicosanoid Metabolites Concentration [ Time Frame: 2 hours ]
    eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge

Secondary Outcome Measures :
  1. Treatment-Related Adverse Events [ Time Frame: 24 hours after the challenge ]
    Adverse reactions defined as bronchospasm requiring endotracheal intubation. The adverse reactions will be assessed through a post challenge follow-up with the patient at baseline and 24 hours after the challenge

  2. Change in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients [ Time Frame: 12 months ]
    We will assess FEV1% change from baseline at 12 months in AERD patients who have been on aspirin treatment for 12 months (current standard of care)

Biospecimen Retention:   Samples With DNA
urine, peripheral blood mononuclear cells, plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01320072

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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
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Principal Investigator: Elina Jerschow, MD Attending physician
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Responsible Party: Elina Jerschow, Attending physician, Montefiore Medical Center Identifier: NCT01320072    
Other Study ID Numbers: 10-01-002
First Posted: March 22, 2011    Key Record Dates
Results First Posted: April 5, 2016
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no, patients signed informed consent that allowed us to collect data for the present study but not to share the data
Keywords provided by Elina Jerschow, Montefiore Medical Center:
Additional relevant MeSH terms:
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Asthma, Aspirin-Induced
Respiration Disorders
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders