RECRUITING

Nasal Potential Difference (NPD) Protocol in Chronic Rhinosinusitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Chloride Secretagogues for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (NPD Protocol)

Quick Facts

Study Start:2015-01

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02038166

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Discolored nasal drainage arising from the nasal passages, nasal polyps, or polypoid swelling as identified on physical examination with nasal endoscopy. 2. Edema or erythema of the middle meatus or ethmoid bulla 3. 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. 4. 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	1. Acute illness within 2 weeks before start of study treatment. 2. History of major asthma attack within 2 months prior to start of study treatment. 3. Change in intranasal medications (including use of corticosteroids, cromolyn, atrovent, phenylephrine, or oxymetazoline) within 14 days prior to start of study treatment. 4. Positive hepatitis B surface antigen, hepatitis C antibody test, or human immunodeficiency virus (HIV) test. 5. Hemoglobin \<10 gm/dL and Serum albumin \<2.5 g/dL. 6. Abnormal liver function (serum ALT, AST, alkaline phosphatase, or total bilirubin \>2 times upper limit of normal). 7. Abnormal renal function (serum creatinine \>1.5 times upper limit of normal). 8. Pregnancy or breast feeding. 9. History of solid organ or hematological transplantation 10. History of autoimmune or granulomatous disorder.

Inclusion Criteria

Exclusion Criteria

1. Discolored nasal drainage arising from the nasal passages, nasal polyps, or polypoid swelling as identified on physical examination with nasal endoscopy.
2. Edema or erythema of the middle meatus or ethmoid bulla
3. 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.
4. 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

1. Acute illness within 2 weeks before start of study treatment.
2. History of major asthma attack within 2 months prior to start of study treatment.
3. Change in intranasal medications (including use of corticosteroids, cromolyn, atrovent, phenylephrine, or oxymetazoline) within 14 days prior to start of study treatment.
4. Positive hepatitis B surface antigen, hepatitis C antibody test, or human immunodeficiency virus (HIV) test.
5. Hemoglobin \<10 gm/dL and Serum albumin \<2.5 g/dL.
6. Abnormal liver function (serum ALT, AST, alkaline phosphatase, or total bilirubin \>2 times upper limit of normal).
7. Abnormal renal function (serum creatinine \>1.5 times upper limit of normal).
8. Pregnancy or breast feeding.
9. History of solid organ or hematological transplantation
10. History of autoimmune or granulomatous disorder.

Contacts and Locations

Study Contact

Norma Miller, RN

CONTACT

(205) 975-6169

ncmiller@uabmc.edu

Principal Investigator

Brad Woodworth, MD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35244

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Brad Woodworth, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2015-01

Study Completion Date2026-12

Study Record Updates

Study Start Date2015-01

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Rhinosinusitis