Back to search results

Ivacaftor for Chronic Rhinosinusitis

This study is looking at whether the medication ivacaftor, when given along with standard treatments like nasal spray and antibiotics, can help people with chronic rhinosinusitis (CRS). CRS is a long-lasting inflammation of the sinuses that can significantly impact quality of life. The study aims to see if ivacaftor is safe and well-tolerated, and if it can improve symptoms and reduce inflammation. You may be able to join if you are at least 18 years old, have a diagnosis of CRS confirmed by a doctor, and have specific findings on a CT scan and a positive culture for certain bacteria. The main goal is to see if your quality of life improves over about 30 days.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Participants will take ivacaftor 150 mg by mouth twice a day for 14 days, along with standard care treatments. Quality of life will be measured from screening up to day 30.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for improvements in quality of life measures up to Day 30.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03439865

Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of Alabama at Birmingham
~20 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Ivacaftorstandard of care treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvement in quality of life measures
Measured over Screening to Day 30

Conditions

Chronic Rhinosinusitis (Diagnosis)

Explore related trials

Chronic Sinusitis

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Bradford Woodworth, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Norma Miller, RN
[email protected]
(205) 975-6169
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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

What this trial measures

  • Improvement in quality of life measuresScreening to Day 30

    Comparison of 22-tem Sino-Nasal Outcomes Test (SNOT-22) scores collected at Screening, Day 1, Day 14, and Day 30. The SNOT-22 is a 22-item questionnaire about rhinosinusitis symptoms and the social/emotional consequences for quality of life. The Likert scale ranges from 1-5, where 1 = "No Problem" and 5 = "Problem as bad as it can be." A total score is collected, ranging from 0-110; the higher the score, the worse the outcome.