Nasal Potential Difference (NPD) Protocol in Chronic Rhinosinusitis

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Jan 14, 2014

Keywords

ClinConnect Summary

This clinical trial is investigating the role of a specific deficiency in a protein called CFTR in causing Chronic Rhinosinusitis (CRS), a condition that leads to prolonged inflammation and blockage of the nasal passages. The researchers want to see if this deficiency affects the ability of the body to clear mucus from the sinuses effectively, which is important for keeping the nasal passages healthy. The study is currently looking for participants between the ages of 19 and 74 who have been diagnosed with CRS and meet certain health criteria.

To be eligible for this study, participants must have ongoing symptoms of CRS for at least 12 weeks and show specific signs of inflammation, such as discolored nasal drainage or swelling in the nasal passages. Participants should also be generally healthy enough to safely take part in the study and perform a test called Nasal Potential Difference (NPD). Those with recent acute illnesses, significant asthma attacks, or certain health conditions may not be eligible. If you join the study, you can expect to undergo various tests and evaluations to help researchers understand more about CRS and its underlying causes.

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ALL

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.