NCT03439865 Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis
| NCT ID | NCT03439865 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Chronic Rhinosinusitis (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2019-05-02 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2019-05-02 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Bradford Woodworth, MD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT03439865 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Rhinosinusitis (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03439865 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03439865 currently recruiting?
Yes, NCT03439865 is actively recruiting participants. Contact the research team at ncmiller@uabmc.edu for enrollment information.
Where is the NCT03439865 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT03439865 clinical trial?
NCT03439865 is sponsored by University of Alabama at Birmingham. The principal investigator is Bradford Woodworth, MD at University of Alabama at Birmingham. The trial plans to enroll 20 participants.