Trial Outcomes & Findings for Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease (NCT NCT01320072)
NCT ID: NCT01320072
Last Updated: 2023-02-17
Results Overview
eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge
Recruitment status
TERMINATED
Target enrollment
29 participants
Primary outcome timeframe
2 hours
Results posted on
2023-02-17
Participant Flow
Participant milestones
| Measure |
Aspirin-sensitive Asthmatics
Patients with aspirin exacerbated respiratory disease, N=16
|
Aspirin-tolerant Asthmatics
Aspirin tolerant asthma patients, N=13
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
13
|
|
Overall Study
COMPLETED
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease
Baseline characteristics by cohort
| Measure |
Aspirin-sensitive Asthmatics
n=16 Participants
patients with aspirin exacerbated respiratory disease
|
Aspirin-tolerant Asthmatics
n=13 Participants
aspirin-tolerant patients with asthma
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 3.2 • n=99 Participants
|
42.6 years
STANDARD_DEVIATION 2.4 • n=107 Participants
|
40.3 years
STANDARD_DEVIATION 2.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
13 participants
n=107 Participants
|
29 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 hourseicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge
Outcome measures
| Measure |
Aspirin-sensitive Asthmatics
n=16 Participants
Patients with aspirin exacerbated respiratory disease, N=16
|
Aspirin-tolerant Asthmatics
n=13 Participants
Aspirin tolerant asthma patients, N=13
|
|---|---|---|
|
Eicosanoid Metabolites Concentration
|
6.91 log-pg/mg creatinine
Standard Error 0.15
|
5.8 log-pg/mg creatinine
Standard Error 0.12
|
SECONDARY outcome
Timeframe: 24 hours after the challengeAdverse 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
Outcome measures
| Measure |
Aspirin-sensitive Asthmatics
n=16 Participants
Patients with aspirin exacerbated respiratory disease, N=16
|
Aspirin-tolerant Asthmatics
n=13 Participants
Aspirin tolerant asthma patients, N=13
|
|---|---|---|
|
Treatment-Related Adverse Events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: AERD patients will continue aspirin treatment for 12 months and the change from baseline in their FEV1% predicted will be monitored during this time
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)
Outcome measures
| Measure |
Aspirin-sensitive Asthmatics
n=16 Participants
Patients with aspirin exacerbated respiratory disease, N=16
|
Aspirin-tolerant Asthmatics
Aspirin tolerant asthma patients, N=13
|
|---|---|---|
|
Change in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients
|
12 change in percent predicted FEV1
Standard Error 1.1
|
—
|
Adverse Events
Aspirin-sensitive Asthmatics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aspirin-tolerant Asthmatics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elina Jerschow, attending physician
Montefiore Medical Center
Phone: 9173625291
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place