Nasal Potential Difference (NPD) Protocol in Chronic Rhinosinusitis
United States20 participantsStarted 2015-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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).