Asthma, Aspirin-induced Clinical Trial
— ASASOfficial title:
Diagnosis of Aspirin Hypersensitivity in Aspirin Exacerbated Respiratory Disease Using a Safe, Low Dose Aspirin Challenge
NCT number | NCT01320072 |
Other study ID # | 10-01-002 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | May 2010 |
Est. completion date | May 26, 2022 |
Verified date | February 2023 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 29 |
Est. completion date | May 26, 2022 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Eicosanoid Metabolites Concentration | eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge | 2 hours | |
Secondary | 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 | 24 hours after the challenge | |
Secondary | 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) | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT01681615 -
Challenge Test for Acetylsalicylic Acid Hypersensitivity
|
N/A | |
Completed |
NCT01867281 -
The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
|
Phase 4 | |
Completed |
NCT02824523 -
Role of Inflammatory Mediators in AERD
|
||
Active, not recruiting |
NCT03028350 -
Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
|
Phase 2 | |
Completed |
NCT01597375 -
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)
|
Phase 2 | |
Recruiting |
NCT04823585 -
Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)
|
N/A | |
Recruiting |
NCT05575037 -
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease
|
Phase 2 | |
Completed |
NCT03326063 -
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban
|
Phase 2 |