Nasal Potential Difference (NPD) Protocol in Chronic Rhinosinusitis
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|ClinicalTrials.gov Identifier: NCT02038166|
Recruitment Status : Recruiting
First Posted : January 16, 2014
Last Update Posted : September 5, 2017
|Condition or disease|
Nasal Potential Difference (NPD) measurements will be conducted on participants. The NPD measurement, is a bioelectric assay of CFTR-dependent ion transport that has been used in a variety of protocols designed to detect CFTR function. A 4-Step protocol will be utilized. The nasal cavities will be perfused in a step-wise fashion with the following solutions: 1) Ringer's solution, 2) Ringer's solution + amiloride 100μM, 3) Low-Cl--containing solution, and 4) Low-Cl- + isoproterenol (10 µM). The potential difference will be monitored in nasal epithelium in comparison to an agar filled reference butterfly electrode placed in the volar aspect of the forearm, and connected via a calomel cell to a high impedance voltmeter.
Following placement of the subcutaneous reference bridge, the nasal probe will be secured 1-3 cm within the inferior meatus and secured in position at the most polarizing position. Each nare will then be sequentially perfused with Ringer solution. All nasal potential difference tracings will be scored independently by a single reviewer.
The investigator and an internal committee comprised of Gregory Fleming James Associate Scientists will oversee the safety of the study. Our internal committee is a multidisciplinary group consisting of physician and subspecialists who, collectively, have experience in treatment patients with cystic fibrosis and other airway disease in the conduct of randomized clinical trials. The primary responsibility of this committee is to protect the safety and welfare of subjects consenting to the investigator's procurement of remnant tissue during endoscopic sinus procedure. Members are responsible for reviewing procedural conduct, including acquisition of consents and materials, to protect patient well-being. An interim data safety review will be conducted on a yearly basis. The committee will consist of at least 3 members with clinical trials experience in airway diseases. During annual review, issues relating to the safety and process for acquiring human tissues will be reviewed. Summary reports from each annual meeting will be prepared and will address concerns about the procurement of tissue or any other information deemed pertinent to the review.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Chloride Secretagogues for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (NPD Protocol)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
- Measurable Difference in CFTR function [ Time Frame: One Year ]A >-5 mV increase in total chloride secretion (change in NPD following nominal Cl- solution + amiloride + isoproterenol) is typically designated as evidence of measurable difference in CFTR function. Results of NPD measurements between CRS patients and healthy controls will be examined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038166
|Contact: Lisa Clemons, MSN, RN||(205) firstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35244|
|Principal Investigator:||Brad Woodworth, MD||University of Alabama at Birmingham|