Assessing Nasal Function in Chronic Rhinosinusitis

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

This study is testing how a specific gene problem might affect nasal function in people with chronic sinus issues.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT02038166 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the role of acquired Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) deficiency in the development of Chronic Rhinosinusitis (CRS). Participants will undergo Nasal Potential Difference (NPD) measurements, which assess CFTR-dependent ion transport through a series of perfusions in the nasal cavities. The study will utilize a 4-Step protocol to evaluate the bioelectric responses of the nasal epithelium, monitored against a reference electrode. A multidisciplinary committee will oversee the safety and integrity of the study, ensuring that participants meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with Chronic Rhinosinusitis who are otherwise healthy and can safely participate in the study.

Not a fit: Patients with severe comorbid conditions or those not meeting the CRS diagnostic criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of CRS mechanisms and lead to improved treatment strategies for patients.

How similar studies have performed: While the approach of using NPD measurements is established, the specific application to CRS in this context is novel and has not been extensively tested.

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.

Where this trial is running

Birmingham, Alabama

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

Study contacts

• Principal investigator: Brad Woodworth, MD — University of Alabama at Birmingham
• Study coordinator: Norma Miller, RN

Conditions Rhinosinusitis