Nasal Potential Difference (NPD) Protocol in Chronic Rhinosinusitis

Recruiting now

Conditions studied: Rhinosinusitis

In brief

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).

Key facts

Study ID

NCT02038166

Run by

University of Alabama at Birmingham

People needed

20

Starts

2015-01-01

Expected to finish

2027-12-01

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• a. 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

You may not qualify if…

• 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).
• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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