Actively Recruiting
Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis
Led by University of Alabama at Birmingham · Updated on 2026-04-22
20
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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; produce detectable improvements in validated measures of CRS including the SNOT-22 questionnaire, Lund-MacKay CT scan grading, and Lund-Kennedy endoscopic scores; and provide beneficial effects on readily measured markers of sinonasal inflammation and infection (IP-10, IL-8, and Pseudomonas CFUs).
CONDITIONS
Official Title
Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age
- Patient has provided informed consent
- Diagnosis of chronic rhinosinusitis (CRS) made by an investigator
- CT scan within 30 days showing mucosal thickening, bone changes, or air fluid levels
- Positive culture for gram-negative bacteria within 30 days prior to testing
- Previous sinus surgery exposing maxillary and ethmoid sinuses
- Ability to perform nasal potential difference testing with sufficient nasal cavity space
- Negative pregnancy test for females of childbearing potential within 72 hours before treatment
You will not qualify if you...
- Younger than 18 years
- Acute illness other than sinusitis within 2 weeks before treatment that may prevent participation
- Taking moderate or strong CP3A inhibitor medications
- History of asthma attack requiring emergency care or oral steroids within 2 months prior
- History of solid organ or blood transplantation
- Known immunodeficiency, autoimmune, or granulomatous disorders
- Serum creatinine greater than 1.5 times upper normal limit
- Abnormal liver function tests above twice the upper normal limit
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
N
Norma Miller, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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