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
Recruitment status was Recruiting
Sponsor:
Montefiore Medical Center
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01320072
First received: March 17, 2011
Last updated: March 18, 2011
Last verified: March 2011
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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:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
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:
|
Hypersensitivity Respiration Disorders Respiratory Tract Diseases Immune System Diseases Aspirin 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 June 17, 2013