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ACTIVE NOT RECRUITING
NCT02997020

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

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2017-05-18

Completion Date

2026-04

Last Updated

2025-04-16

Healthy Volunteers

No

Conditions

Interventions

OTHER

EDSPD

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States