Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease

NCT01320072 | Terminated Results DMC

• 1 other identifier: 10-01-002
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma, Aspirin-induced

Keywords

aspirin; asthma; diagnosis; prostaglandins; leukotrienes

Outcome Measures

Primary Outcomes (1)

• Eicosanoid Metabolites Concentration

  eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge

  2 hours

Secondary Outcomes (2)

• Treatment-Related Adverse Events

  24 hours after the challenge

• Change in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients

  12 months

Study Arms (2)

Aspirin-sensitive asthmatics

asthma patients with aspirin allergy

aspirin-tolerant asthmatics

asthma patients without aspirin allergy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Allergy/Immunology clinic population in Bronx, NY

You may qualify if:

• 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.

You may not qualify if:

• 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 ≥ 3 times above upper normal range).
• 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 visits.
• Participants taking leukotriene receptors inhibitors or 5-lypooxygenase (5-LO) inhibitors at the time of the study visits.
• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (1)

• Jerschow E, Ren Z, Hudes G, Sanak M, Morales E, Schuster V, Spivack SD, Rosenstreich D. Utility of low-dose oral aspirin challenges for diagnosis of aspirin-exacerbated respiratory disease. Ann Allergy Asthma Immunol. 2016 Apr;116(4):321-328.e1. doi: 10.1016/j.anai.2015.12.026. Epub 2016 Jan 25.

  PMID: 26822279 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

urine, peripheral blood mononuclear cells, plasma

MeSH Terms

Conditions

Asthma, Aspirin-Induced; Asthma; Disease

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Lung Diseases, Obstructive; Lung Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Elina Jerschow, attending physician
• Organization: Montefiore Medical Center

ejerscho@montefiore.org

9173625291

Study Officials

• Elina Jerschow, MD

  Attending physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 22, 2011
• Study Start: May 1, 2010
• Primary Completion: October 1, 2016
• Study Completion: May 26, 2022
• Last Updated: February 17, 2023
• Results First Posted: April 5, 2016

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)