Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease (ASAS)
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.
Aspirin Exacerbated Respiratory Disease
|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|
- 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
- Number of Participants With Treatment-Related Adverse Events as Assessed by change in forced expiratory volume in 1 second (FEV1) and by the presence of adverse reactions, such as upper and/or lower respirtory symptoms, GI symptoms, or skin rash [ Time Frame: 24 hours after the challenge ] [ Designated as safety issue: Yes ]FEV1 will be assessed at baseline and after aspirin challenges, changes in FEV1 will be recorded. The adverse reactions will be assessed by symptom questionnaires
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320072
|United States, New York|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Elina Jerschow, MD 917-362-5291 email@example.com|
|Principal Investigator: Elina Jerschow, MD|