๐ฌIn plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 (โฅ 2 major factors or at least 1 major factor \& 2 minor symptoms; Table 2) for โฅ 12 consecutive weeks or โฅ 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 โฅ 19 years and Weight โฅ 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.