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RECRUITING
NCT03439865
EARLY_PHASE1

Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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; 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).

Official title: Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (Randomized Pilot Study Utilizing Ivacaftor for the Treatment of Refractory Gram-Negative Bacterial CRS)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2019-05-02

Completion Date

2026-04

Last Updated

2025-04-16

Healthy Volunteers

No

Interventions

DRUG

Ivacaftor

150 mg tablet PO BID x 14 days

DRUG

standard of care treatment

topical nasal steroid spray and culture-directed antibiotics x 14 days

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States