Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (EDSPD Protocol) (NCT02997020) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (EDSPD Protocol)
United States30 participantsStarted 2017-05-18
Plain-language summary
The purpose of this study is to establish the novel endoscopically-directed sinus potential difference (EDSPD) assay as an endpoint for therapy of sinus disease.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patient eligibility criteria are designed to limit enrollment otherwise healthy individuals who are scheduled for standard-of-care nasal endoscopy in the clinic or sinus/skull base surgery.
Inclusion criteria:
* Age \> 18 years
* Able to give consent
* A diagnosis of CRS, as determined by the Sinus and Allergy Health Partnership criteria
* Has cultured out at least one gram negative bacteria (e.g. Pseudomonas aeruginosa, Escherichia coli, Stenotrophomonas maltophila) within the previous month
* Is scheduled for either routine endoscopic surgery or has previously undergone endoscopic surgery and presents to clinic for routine endoscopic evaluation
Exclusion criteria:
* Age \< 18 years
* Unable to give consent
* Active diagnosis of cancer, autoimmune disease, or any know immunodeficiency
* Women who are pregnant or breastfeeding
What they're measuring
1
Ability to measure CFTR difference using EDSPD testing