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NCT03439865 · ClinicalTrials.gov registry record · Early Phase 1
Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis
A Early Phase 1 study of Chronic Rhinosinusitis (Diagnosis), sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03439865: Recruiting Early Phase 1 study of Chronic Rhinosinusitis (Diagnosis), sponsored by University of Alabama at Birmingham.
NCT03439865 is a Early Phase 1 study of Chronic Rhinosinusitis (Diagnosis) that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 20 participants, below the 88-participant average among 9 other Chronic Rhinosinusitis (Diagnosis) trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03439865, a Early Phase 1 study of Chronic Rhinosinusitis (Diagnosis), is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Ivacaftor
- DRUG standard of care treatment
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-05-02 |
| Est. Completion | 2026-04 |
| Phase | Early Phase 1 |
What NCT03439865 shows while recruiting
NCT03439865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 88-participant average among 9 other Chronic Rhinosinusitis (Diagnosis) trials with a reported enrollment target (77% lower).
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.
NCT03439865 reports a single indexed study location in Alabama.
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).
What interventions are being tested in trial NCT03439865?
The interventions under investigation include: Ivacaftor (DRUG), standard of care treatment (DRUG).
Who is sponsoring clinical trial NCT03439865?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Chronic Rhinosinusitis (Diagnosis)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03439865's enrollment target sits among peer trials
20 9th of 9 higher than 1 of 9 other Chronic Rhinosinusitis (Diagnosis) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Rhinosinusitis (Diagnosis) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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