RhinosinusitisNCT02038166
Nasal Potential Difference (NPD) Protocol in Chronic Rhinosinusitis
An observational study of Rhinosinusitis, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinosinusitis
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to UAB for evaluation of CRS
Who may be able to join
- Patients with CRS will be diagnosed according to Sinus and Allergy Health Partnership symptom-based and objective criteria as follows: i. Duration of disease is qualified by continuous symptoms (≥ 2 major factors or at least 1 major factor \& 2 minor symptoms; Table 2) for ≥ 12 consecutive weeks or ≥ 12 weeks of physical findings. ii. One of these signs of inflammation must be present and identified in association with ongoing symptoms.
- Discolored nasal drainage arising from the nasal passages, nasal polyps, or polypoid swelling as identified on physical examination with nasal endoscopy.
- Edema or erythema of the middle meatus or ethmoid bulla
- Generalized or localized erythema or edema. If it does not involve the middle meatus or ethmoid bulla, CT scan is performed to confirm a diagnosis.
- The CT scan must demonstrate isolated or diffuse mucosal thickening, bone changes, air-fluid levels. b. Age ≥ 19 years and Weight ≥ 50 kg c. Ability to perform NPD testing d. Negative pregnancy test (for females of childbearing potential) e. Written informed consent
Who cannot join
- Acute illness within 2 weeks before start of study treatment.
- History of major asthma attack within 2 months prior to start of study treatment.
- Change in intranasal medications (including use of corticosteroids, cromolyn, atrovent, phenylephrine, or oxymetazoline) within 14 days prior to start of study treatment.
- Positive hepatitis B surface antigen, hepatitis C antibody test, or human immunodeficiency virus (HIV) test.
- Hemoglobin <10 gm/dL and Serum albumin <2.5 g/dL.
- Abnormal liver function (serum ALT, AST, alkaline phosphatase, or total bilirubin >2 times upper limit of normal).
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- Abnormal renal function (serum creatinine >1.5 times upper limit of normal).
- Pregnancy or breast feeding.
- History of solid organ or hematological transplantation
- History of autoimmune or granulomatous disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35244
Norma Miller, RN, (205) 975-6169, ncmiller@uabmc.edu
About this study
Official title: Chloride Secretagogues for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (NPD Protocol)
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).
Read the 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) 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.
- Conditions
- Rhinosinusitis
- Medical subject headings
- Rhinosinusitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurable Difference in CFTR function
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.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Brad Woodworth, MD, University of Alabama at Birmingham
- Investigators
- Brad Woodworth, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038166
- Sponsor's protocol ID
- IRB-100930005
- Other IDs
- 1K08HL107142-01
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2014
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chloride Secretagogues for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (NPD Protocol)
- ClinicalTrials.gov ID
- NCT02038166
- Acronym / sponsor ID
- IRB-100930005
- Conditions
- Rhinosinusitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to UAB for evaluation of CRS
Key inclusion criteria (5 listed)
- Patients with CRS will be diagnosed according to Sinus and Allergy Health Partnership symptom-based and objective criteria as follows: i. Duration of disease is qualified by continuous symptoms (≥ 2 major factors or at least 1 major factor \& 2 minor symptoms; Table 2) for ≥ 12 consecutive weeks or ≥ 12 weeks of physical findings. ii. One of these signs of inflammation must be present and identified in association with ongoing symptoms.
- Discolored nasal drainage arising from the nasal passages, nasal polyps, or polypoid swelling as identified on physical examination with nasal endoscopy.
- Edema or erythema of the middle meatus or ethmoid bulla
- Generalized or localized erythema or edema. If it does not involve the middle meatus or ethmoid bulla, CT scan is performed to confirm a diagnosis.
- The CT scan must demonstrate isolated or diffuse mucosal thickening, bone changes, air-fluid levels. b. Age ≥ 19 years and Weight ≥ 50 kg c. Ability to perform NPD testing d. Negative pregnancy test (for females of childbearing potential) e. Written informed consent
Key exclusion criteria (10 listed)
- Acute illness within 2 weeks before start of study treatment.
- History of major asthma attack within 2 months prior to start of study treatment.
- Change in intranasal medications (including use of corticosteroids, cromolyn, atrovent, phenylephrine, or oxymetazoline) within 14 days prior to start of study treatment.
- Positive hepatitis B surface antigen, hepatitis C antibody test, or human immunodeficiency virus (HIV) test.
- Hemoglobin <10 gm/dL and Serum albumin <2.5 g/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brad Woodworth, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinosinusitis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norma Miller, RN ((205) 975-6169, ncmiller@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurable Difference in CFTR function (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.