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RECRUITING Early Phase 1

Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis

NCT03439865 · View on ClinicalTrials.gov ↗

Study 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).

Interventions

  • DRUG Ivacaftor
  • DRUG standard of care treatment

Study Locations (1)

Alabama

  • University of Alabama at Birmingham — Birmingham

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2019-05-02
Est. Completion 2026-04
Phase Early Phase 1

Sponsor

University of Alabama at Birmingham

1,315 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03439865

The ClinicalTrials.gov registry entry for NCT03439865 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Rhinosinusitis (Diagnosis) appearing as the primary indexed condition, and to 2 interventions — of which Ivacaftor is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03439865 reports 1 study location spanning 1 distinct geographic area — top geographies include Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03439865 about?

NCT03439865 is a clinical study titled "Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis". 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, Lun...

What is the current status of trial NCT03439865?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2019-05-02. Estimated completion is 2026-04.

What conditions does trial NCT03439865 study?

This clinical trial studies the following conditions: Chronic Rhinosinusitis (Diagnosis). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03439865?

The interventions under investigation include: Ivacaftor (DRUG), standard of care treatment (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03439865?

This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03439865 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial