Ignite Creation Date:
2024-05-06 @ 2:22 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02038166
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2014-01-09
Brief Title:
Nasal Potential Difference NPD Protocol in Chronic Rhinosinusitis
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Chloride Secretagogues for Acquired CFTR Dysfunction in Chronic Rhinosinusitis NPD Protocol
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if acquired partial Cystic Fibrosis Transmembrane Conductance Regulator CFTR deficiency contributes substantially to the pathogenic mechanisms underlying Chronic Rhinosinusitis CRS creating a localized environment that impairs mucociliary clearance MCC
Detailed Description:
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 Ringers solution 2 Ringers 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 investigators 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
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 investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K08HL107142-01 | NIH | None | httpsreporternihgovquickSearch1K08HL107142-01 |