RecruitingEarly Phase 1NCT03439865

Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis

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


Sponsor

University of Alabama at Birmingham

Enrollment

20 participants

Start Date

May 2, 2019

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ivacaftor and a drug called standard of care treatment for people with chronic rhinosinusitis (diagnosis). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvacaftor

150 mg tablet PO BID x 14 days

DRUGstandard 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

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NCT03439865


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