Using Ivacaftor to treat chronic rhinosinusitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the safety and tolerability of ivacaftor in patients with refractory chronic rhinosinusitis (CRS). It will assess whether ivacaftor can restore CFTR-mediated chloride secretions and improve CRS symptoms through various validated measures, including the SNOT-22 questionnaire and CT scan grading. The study will also investigate its effects on markers of sinonasal inflammation and infection. By exploring this novel approach, the study seeks to address the significant clinical need for new treatments for CRS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* \< 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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Bradford Woodworth, MD — University of Alabama at Birmingham
• Study coordinator: Norma Miller, RN
• Email: ncmiller@uabmc.edu
• Phone: (205) 975-6169

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.