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New treatment option for Chronic Rhinosinusitis (Diagnosis)
Official title Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis
ClinicalTrials.gov ID: NCT03439865
What this study is testing
What is Ivacaftor?
Ivacaftor is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic rhinosinusitis (diagnosis).
Also referred to as Kalydeco.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Positive culture of at least one gram negative bacteria (e.g. Pseudomonas, E. coli, Steenotrophomonas) within 30 days prior to testing
You likely can't join if
- \< 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...
- 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
See the full eligibility 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
- \< 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.