Clinical Trial: Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease Using a Safe, Low Dose Aspirin Challenge

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.


Detailed Summary:

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.


Sponsor: Montefiore Medical Center

Current Primary Outcome: Eicosanoid Metabolites Concentration [ Time Frame: 2 hours ]

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


Original Primary Outcome: eicosanoid metabolites concentration in plasma and urine [ Time Frame: 2 hours ]

collection of the specimens after 2 h post ASA challenge


Current Secondary Outcome:

  • 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)


Original Secondary Outcome: safety and tolerability of the low dose aspirin challenge [ Time Frame: 24 hours after the challenge ]

Information By: Montefiore Medical Center

Dates:
Date Received: March 17, 2011
Date Started: May 2010
Date Completion: December 2020
Last Updated: April 3, 2016
Last Verified: April 2016