Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (EDSPD Protocol)

N/AActive Not RecruitingNCT02997020

University of Alabama at Birmingham30 enrolled

Overview

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.

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. This assay provides a means to measure Cl- secretion across the sinus epithelium in human subjects with chronic rhinosinusitis (CRS) and test the relationship between this data and endoscopic findings of inflammation. The technique is appropriate for investigating acquired CFTR dysfunction in sinus epithelium and examining the therapeutic potential of CFTR potentiators for CRS.

Study Type

OBSERVATIONAL

Enrollment

Conditions

CRS

Interventions

EDSPDOTHER

The equipment \& conditions for measuring bioelectric changes across the sinus mucosa are based on the standard NPD protocol, including use of agar-filled PE90 tubing for the probing electrode and limiting perfusion solutions to Ringer, Ringer + amiloride (100 µM), chloride-free gluconate with amiloride + isoproterenol (10 µM). The potential difference will be monitored in actively inflamed areas as judged by endoscopy in comparison to an agar-filled reference butterfly electrode placed in the volar aspect of the forearm. A stable potential with the mean value of a 10-s scoring interval after perfusion of each solution will be recorded by a blinded investigator.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Ability to measure CFTR difference using EDSPD testing

To establish the relationship of EDSPD findings with other validated instruments and markers of CRS disease

Time frame: 3 Years

Data from ClinicalTrials.gov

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