Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease (ASAS)
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|ClinicalTrials.gov Identifier: NCT01320072|
Recruitment Status : Completed
First Posted : March 22, 2011
Results First Posted : April 5, 2016
Last Update Posted : October 27, 2017
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|
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.
|Study Type :||Observational|
|Actual Enrollment :||29 participants|
|Official Title:||Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease Using a Safe, Low Dose Aspirin Challenge|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||December 2016|
asthma patients with aspirin allergy
asthma patients without aspirin allergy
- Eicosanoid Metabolites Concentration [ Time Frame: 2 hours ]eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01320072
|United States, New York|
|Montefiore Medical Center|
|The Bronx, New York, United States, 10461|
|Principal Investigator:||Elina Jerschow, MD||Attending physician|