- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02997020
Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (EDSPD Protocol)
March 22, 2024 updated by: Brad Woodworth, MD, University of Alabama at Birmingham
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.
Study Overview
Detailed 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.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Participants will be derived from those patients presenting to UAB for endoscopic evaluation of CRS, or who present for standard-of-care sinus or skull base surgery.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CRS Patients
Endoscopically-directed sinus potential difference (EDSPD) will be conducted in either the operating room or in the rhinology clinic setting to quantify CFTR activity in the sinus cavities.
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.
|
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.
|
Control Patients
Endoscopically-directed sinus potential difference (EDSPD) will be conducted in either the operating room or in the rhinology clinic setting to quantify CFTR activity in the sinus cavities.
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ability to measure CFTR difference using EDSPD testing
Time Frame: 3 Years
|
To establish the relationship of EDSPD findings with other validated instruments and markers of CRS disease
|
3 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Brad Woodworth, MD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2017
Primary Completion (Actual)
December 13, 2019
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
December 14, 2016
First Submitted That Met QC Criteria
December 14, 2016
First Posted (Estimated)
December 19, 2016
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 22, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-160516002
- 1R01HL133006 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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