Nasal Potential Difference (NPD) Protocol in Chronic Rhinosinusitis
ConditionRhinosinusitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients presenting to UAB for evaluation of CRS
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
One YearSponsors and contacts
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University of Alabama at Birmingham
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov