Status:
RECRUITING
Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Chronic Rhinosinusitis (Diagnosis)
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this pilot study is to explore wither ivacaftor in refractory CRS patients will demonstrate safety and tolerability; restore CFTR-mediated Cl- secretions as measured by EDSPD testing; p...
Detailed Description
There is a significant clinical need for new treatment modalities for chronic sinus disease. Chronic rhinosinusitis (CRS) causes substantial morbidity and detracts from quality of life for 16% of the ...
Eligibility Criteria
Inclusion
- 18 years of age
- Patient has provided informed consent
- Diagnosis of CRS made by one of the investigators
- Standard of care CT scan with definitive demonstration of isolated or diffuse mucosal thickening, bone changes, and air fluid levels, obtained within 30 days of treatment
- Positive culture of at least one gram negative bacteria (e.g. Pseudomonas, E. coli, Steenotrophomonas) within 30 days prior to testing
- Previous surgery with (at least) exposed maxillary and ethmoid sinuses
- Ability to perform EDSPD testing such that nasal cavity space and sinus openings are sufficient for catheter placement
- Negative pregnancy test for females of childbearing potential within 72 hours of testing and start of study treatment
Exclusion
- \< 18 years of age
- Acute illness other than sinusitis within 2 weeks before start of study treatment that, in the opinion of the investigator, would preclude participation
- Currently taking medications that are moderate or strong CP3A inhibitors
- History of asthma attack requiring emergency room visit or treatment with oral steroids within 2 months prior to study treatment
- History of solid organ or hematological transplantation
- History of known immunodeficiency, autoimmune or granulomatous disorder
- Serum creatinine \> 1.5x upper normal limit
- Abnormal liver function, as defined by serum AST \> 2x upper normal limit, serum ALT \> 2x upper normal limit, Alkaline phosphatase \> 2x upper normal limit, Total bilirubin \> 2x upper normal limit
- Women who are pregnant or breastfeeding
Key Trial Info
Start Date :
May 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03439865
Start Date
May 2 2019
End Date
April 1 2026
Last Update
April 16 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233