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NCT04580368 · ClinicalTrials.gov registry record · NA
Testing Drug Efficacy in Cystic Fibrosis Through N-of-1 Trials
A NA study of Cystic Fibrosis, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04580368: Recruiting NA study of Cystic Fibrosis, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04580368 is a NA study of Cystic Fibrosis that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 50 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04580368, a NA study of Cystic Fibrosis, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to validate and utilize a personalized medicine approach to identify potential treatments with current FDA approved CFTR modifiers for non-approved CF gene mutations. The study will perform ex vivo testing of CFTR function and current marketed CFTR modulating drugs on expanded nasal cells at Cincinnati Children's Human Nasal Epithelium (HNE) Core Laboratory. The results will be confirmed and translated into bedside care through an N of 1 trial to determine effectiveness of treatment.
Primary Outcome
Absolute change in ppFEV1 of 5% or greater
Conditions Studied
Interventions
- DRUG CFTR Modulators
Study Locations (1)
Ohio
- CCHMC - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-05-01 |
| Est. Completion | 2030-01-31 |
| Phase | NA |
What NCT04580368 shows while recruiting
NCT04580368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which CFTR Modulators is the first listed.
NCT04580368 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04580368 about?
NCT04580368 is a clinical study titled "Testing Drug Efficacy in Cystic Fibrosis Through N-of-1 Trials". The purpose of this study is to validate and utilize a personalized medicine approach to identify potential treatments with current FDA approved CFTR modifiers for non-approved CF gene mutations. The study will perform ex vivo testing of CFTR function and current marketed CFTR modulating drugs on ex...
What is the current status of trial NCT04580368?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2021-05-01. Estimated completion is 2030-01-31.
What conditions does trial NCT04580368 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT04580368?
The interventions under investigation include: CFTR Modulators (DRUG).
Who is sponsoring clinical trial NCT04580368?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04580368 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
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 NCT04580368's enrollment target sits among peer trials
50 90th of 169 higher than 79 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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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Skin-interfaced Colorimetric Bifluidic Sweat Sensor Device for the Diagnosis of Cystic Fibrosis (CF)
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