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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02997020
Other study ID # IRB-160516002
Secondary ID 1R01HL133006
Status Active, not recruiting
Phase
First received
Last updated
Start date May 18, 2017
Est. completion date December 2024

Study information

Verified date March 2024
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 2024
Est. primary completion date December 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ability to measure CFTR difference using EDSPD testing To establish the relationship of EDSPD findings with other validated instruments and markers of CRS disease 3 Years
See also
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