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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
Sponsor:
Information provided by (Responsible Party):
Elina Jerschow, Montefiore Medical Center

Tracking Information
First Submitted Date March 17, 2011
First Posted Date March 22, 2011
Results First Submitted Date January 8, 2016
Results First Posted Date April 5, 2016
Last Update Posted Date October 27, 2017
Study Start Date May 2010
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 3, 2016)
Eicosanoid Metabolites Concentration [ Time Frame: 2 hours ]
eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge
Original Primary Outcome Measures
 (submitted: March 18, 2011)
eicosanoid metabolites concentration in plasma and urine [ Time Frame: 2 hours ]
collection of the specimens after 2 h post ASA challenge
Change History Complete list of historical versions of study NCT01320072 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 3, 2016)
  • 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 Measures
 (submitted: March 18, 2011)
safety and tolerability of the low dose aspirin challenge [ Time Frame: 24 hours after the challenge ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease
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 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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
urine, peripheral blood mononuclear cells, plasma
Sampling Method Probability Sample
Study Population Allergy/Immunology clinic population in Bronx, NY
Condition Asthma, Aspirin-induced
Intervention Not Provided
Study Groups/Cohorts
  • Aspirin-sensitive asthmatics
    asthma patients with aspirin allergy
  • aspirin-tolerant asthmatics
    asthma patients without aspirin allergy
Publications * Jerschow E, Ren Z, Hudes G, Sanak M, Morales E, Schuster V, Spivack SD, Rosenstreich D. Utility of low-dose oral aspirin challenges for diagnosis of aspirin-exacerbated respiratory disease. Ann Allergy Asthma Immunol. 2016 Apr;116(4):321-328.e1. doi: 10.1016/j.anai.2015.12.026. Epub 2016 Jan 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 3, 2016)
29
Original Estimated Enrollment
 (submitted: March 18, 2011)
26
Actual Study Completion Date December 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01320072
Other Study ID Numbers 10-01-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: no, patients signed informed consent that allowed us to collect data for the present study but not to share the data
Responsible Party Elina Jerschow, Montefiore Medical Center
Study Sponsor Montefiore Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Elina Jerschow, MD Attending physician
PRS Account Montefiore Medical Center
Verification Date September 2017