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Trial record 64 of 252 for:    ASPIRIN AND low-dose aspirin

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

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Prospective
Condition Asthma, Aspirin-induced
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aspirin-sensitive Asthmatics Aspirin-tolerant Asthmatics
Hide Arm/Group Description Patients with aspirin exacerbated respiratory disease, N=16 Aspirin tolerant asthma patients, N=13
Period Title: Overall Study
Started 16 13
Completed 16 13
Not Completed 0 0
Arm/Group Title Aspirin-sensitive Asthmatics Aspirin-tolerant Asthmatics Total
Hide Arm/Group Description patients with aspirin exacerbated respiratory disease aspirin-tolerant patients with asthma Total of all reporting groups
Overall Number of Baseline Participants 16 13 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
13
 100.0%
29
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 13 participants 29 participants
37.8  (3.2) 42.6  (2.4) 40.3  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
Female
10
  62.5%
7
  53.8%
17
  58.6%
Male
6
  37.5%
6
  46.2%
12
  41.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   7.7%
1
   3.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  56.3%
8
  61.5%
17
  58.6%
White
7
  43.8%
4
  30.8%
11
  37.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 13 participants 29 participants
16 13 29
1.Primary Outcome
Title Eicosanoid Metabolites Concentration
Hide Description eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin-sensitive Asthmatics Aspirin-tolerant Asthmatics
Hide Arm/Group Description:
Patients with aspirin exacerbated respiratory disease, N=16
Aspirin tolerant asthma patients, N=13
Overall Number of Participants Analyzed 16 13
Mean (Standard Error)
Unit of Measure: log-pg/mg creatinine
6.91  (0.15) 5.8  (0.12)
2.Secondary Outcome
Title Treatment-Related Adverse Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin-sensitive Asthmatics Aspirin-tolerant Asthmatics
Hide Arm/Group Description:
Patients with aspirin exacerbated respiratory disease, N=16
Aspirin tolerant asthma patients, N=13
Overall Number of Participants Analyzed 16 13
Measure Type: Number
Unit of Measure: participants
0 0
3.Secondary Outcome
Title Change in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
AERD patients will continue aspirin treatment for 12 months and the change from baseline in their FEV1% predicted will be monitored during this time
Arm/Group Title Aspirin-sensitive Asthmatics
Hide Arm/Group Description:
Asthma patients with aspirin exacerbated respiratory disease
Overall Number of Participants Analyzed 16
Mean (Standard Error)
Unit of Measure: change in percent predicted FEV1
12  (1.1)
Time Frame 12 hours
Adverse Event Reporting Description patients will be assessed for adverse reactions during their aspirin challenge (standard of care)
 
Arm/Group Title Aspirin-sensitive Asthmatics Aspirin-tolerant Asthmatics
Hide Arm/Group Description Patients with aspirin exacerbated respiratory disease, N=16 Aspirin tolerant asthma patients, N=13
All-Cause Mortality
Aspirin-sensitive Asthmatics Aspirin-tolerant Asthmatics
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin-sensitive Asthmatics Aspirin-tolerant Asthmatics
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aspirin-sensitive Asthmatics Aspirin-tolerant Asthmatics
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Elina Jerschow, attending physician
Organization: Montefiore Medical Center
Phone: 9173625291
Responsible Party: Elina Jerschow, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01320072     History of Changes
Other Study ID Numbers: 10-01-002
First Submitted: March 17, 2011
First Posted: March 22, 2011
Results First Submitted: January 8, 2016
Results First Posted: April 5, 2016
Last Update Posted: October 27, 2017