A Study Measuring Bleeding and Coagulation Function in Patients with 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: 16-002321
Sponsor Protocol Number: 16-002321
About this study
The purpose of this study is to learn more about aspirin exacerbated respiratory disease (AERD) by collecting blood samples from affected patients to study bleeding and clotting function.
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
- 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 with total SNOT-22 score more than 7 (normal)
- Evaluation in ENT and/or Allergy Clinic with confirmation of chronic sinusitis and/or nasal polyposis
- Willingness to undergo blood draw
Exclusion Criteria
- Has asthma, nasal polyps and lacks a clear history suggestive of ASA sensitivity
- Well controlled AERD (total SNOT-22 scores <7)
- Past history of ASA desensitization with ongoing therapy
- On 5-LO antagonists (Zileuton)
- On anti-coagulation
- 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