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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elina Jerschow, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01320072
First received: March 17, 2011
Last updated: April 3, 2016
Last verified: April 2016
  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
Asthma, Aspirin-induced

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 [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge


Secondary Outcome Measures:
  • Treatment-Related Adverse Events [ Time Frame: 24 hours after the challenge ] [ Designated as safety issue: Yes ]
    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

  • Change in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

Enrollment: 29
Study Start Date: May 2010
Estimated Study Completion Date: December 2020
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Aspirin-sensitive asthmatics
asthma patients with aspirin allergy
aspirin-tolerant asthmatics
asthma patients without aspirin allergy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
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

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Elina Jerschow, MD Attending physician
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: January 8, 2016
Last Updated: April 3, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: the data have been accepted for publication

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

Additional relevant MeSH terms:
Asthma, Aspirin-Induced
Aspirin
Hypersensitivity
Respiration Disorders
Respiratory Tract Diseases
Immune System Diseases
Asthma
Bronchial Diseases
Respiratory Hypersensitivity
Drug Hypersensitivity
Hypersensitivity, Immediate
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on September 29, 2016