Follow-on Study of Coagulation Function in Patients with AERD (Aspirin Exacerbated Respiratory Disease)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-005581
Sponsor Protocol Number: 18-005581
About this study
The purpose of this study is to better characterize the extent the pathways involved in AERD (leukotriene, prostaglandin, and thromboxane) impact coagulation pathways.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients with high index of suspicion for diagnosis of AERD; i.e., asthma, presence of chronic rhinosinusitis with nasal polyps and history of reaction/intolerance to aspirin or NSAIDS (Non-steroidal anti-inflammatory drugs).
- Symptom burden suggesting presence of active disease.These would essentially be patients with total SNOT-22 more than 7 (normal).
- Evaluation in ENT and/or Allergy Clinic with confirmation of chronic sinusitis and/or nasal polyposis.
- Willingness to undergo a blood draw for twolab measures.
Exclusion Criteria:
- Patients with asthma, nasal polyps, who lack a clear history suggestive of ASA sensitivity.
- Patients with well controlled AERD (total SNOT-22 scores <7) or past history of ASA desensitization with ongoing therapy.
- Patients on 5-LO antagonists (Zileuton).
- Patients on anti-coagulation.
- Patients on systemic steroids 6 weeks prior to assessment.
- Women of childbearing age who are pregnant.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Erin O'Brien, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available