TerminatedNCT01320072ASASUpdated Feb 17, 2023Results posted

Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease

An observational study in Asthma, Aspirin-induced, sponsored by Montefiore Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-02-17.

Sponsored by Montefiore Medical Center · Observational

Why this study was terminated

Study discontinued and closed out by IRB. PI left the institution.

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 29
Ages: 18 Years to 90 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Asthma, Aspirin-induced

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Keywords

aspirin
asthma
diagnosis
prostaglandins
leukotrienes

In context

Respiratory Tract Diseases

617 studies on the registry are indexed under Respiratory Tract Diseases; 111 are open to participants now.

This study's enrollment of 29 is below the median of 294 across 216 observational studies indexed under Respiratory Tract Diseases.

Browse Respiratory Tract Diseases studies →

Lead sponsor

Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.

Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Allergy/Immunology clinic population in Bronx, NY

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

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.

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 29 participants (actual)
Biospecimen retention: Samples with dna

Groups and cohorts

Aspirin-sensitive asthmatics
asthma patients with aspirin allergy
aspirin-tolerant asthmatics
asthma patients without aspirin allergy

What researchers measure

Primary outcomes

Eicosanoid Metabolites Concentration
eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge
Time frame: 2 hours

Secondary outcomes

Treatment-Related Adverse Events
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
Time frame: 24 hours after the challenge
Change in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients
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)
Time frame: 12 months

Results

Posted Apr 5, 2016

Participant flow

Participant flow — Overall Study
Milestone	Aspirin-sensitive Asthmatics	Aspirin-tolerant Asthmatics
Started	16	13
Completed	16	13
Not completed	0	0

Outcome measures

PrimaryEicosanoid Metabolites Concentration

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

Time frame:: 2 hours
Reported as:: Mean · log-pg/mg creatinine

Eicosanoid Metabolites Concentration
log-pg/mg creatinine	Aspirin-sensitive Asthmatics	Aspirin-tolerant Asthmatics
Eicosanoid Metabolites Concentration	6.91 ± 0.15	5.8 ± 0.12

SecondaryTreatment-Related Adverse Events

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

Time frame:: 24 hours after the challenge
Reported as:: Number · participants

Treatment-Related Adverse Events
participants	Aspirin-sensitive Asthmatics	Aspirin-tolerant Asthmatics
Treatment-Related Adverse Events	0	0

SecondaryChange in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients

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)

Time frame:: 12 months
Reported as:: Mean · change in percent predicted FEV1

Change in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients
change in percent predicted FEV1	Aspirin-sensitive Asthmatics
Change in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients	12 ± 1.1

Adverse events

Collected over 12 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Aspirin-sensitive Asthmatics	—	0/16 (0%)	0/16 (0%)
Aspirin-tolerant Asthmatics	—	0/13 (0%)	0/13 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Aspirin-sensitive Asthmatics	Aspirin-tolerant Asthmatics	Total
<=18 years	0	0	0
Between 18 and 65 years	16	13	29
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Aspirin-sensitive Asthmatics	Aspirin-tolerant Asthmatics	Total
Mean	37.8 ± 3.2	42.6 ± 2.4	40.3 ± 2.9

Sex: Female, Male
Sex: Female, Male(Participants)	Aspirin-sensitive Asthmatics	Aspirin-tolerant Asthmatics	Total
Female	10	7	17
Male	6	6	12

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Aspirin-sensitive Asthmatics	Aspirin-tolerant Asthmatics	Total
American Indian or Alaska Native	0	0	0
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	9	8	17
White	7	4	11
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Aspirin-sensitive Asthmatics	Aspirin-tolerant Asthmatics	Total
United States	16	13	29

Study locations

1 site

Montefiore Medical Center
Bronx, New York 10461, United States

References and documents

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. PubMed 26822279 ↗

Individual participant data

Plan to share: No — no, patients signed informed consent that allowed us to collect data for the present study but not to share the data

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01320072
Lead sponsor: Montefiore Medical Center
Responsible party: Sponsor
First posted: Mar 22, 2011
Start date: May 2010
Primary completion: Oct 2016
Completion: May 26, 2022
Results posted: Apr 5, 2016
Last update: Feb 17, 2023

Study contacts

Elina Jerschow, MD

principal investigator · Attending physician

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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