NCT02038166 Nasal Potential Difference (NPD) Protocol in Chronic Rhinosinusitis
| NCT ID | NCT02038166 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Rhinosinusitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2015-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2015-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
The patient eligibility criteria are designed to limit enrollment to healthy individuals and patients who clearly have CRS based on Sinus and Allergy health partnership criteria, but who are sufficiently well (both in terms of CRS and in terms of concomitant illness, such as asthma) to safely participate in study procedures and provide interpretable results. Inclusion Criteria: 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. 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 Exclusion Criteria: 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.
Contact & Investigator
Brad Woodworth, MD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT02038166 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rhinosinusitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02038166 currently recruiting?
Yes, NCT02038166 is actively recruiting participants. Contact the research team at ncmiller@uabmc.edu for enrollment information.
Where is the NCT02038166 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT02038166 clinical trial?
NCT02038166 is sponsored by University of Alabama at Birmingham. The principal investigator is Brad Woodworth, MD at University of Alabama at Birmingham. The trial plans to enroll 20 participants.