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NCT05685186 · ClinicalTrials.gov registry record
A Longitudinal, Observational Study of Primary Ciliary Dyskinesia in Adults
A clinical trial of Primary Ciliary Dyskinesia, sponsored by ReCode Therapeutics.
- Active
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT05685186: Active study of Primary Ciliary Dyskinesia, sponsored by ReCode Therapeutics.
NCT05685186 is a study of Primary Ciliary Dyskinesia that is active but no longer recruiting, run by ReCode Therapeutics. The registered enrollment target is 50 participants, below the 103-participant average among 7 other Primary Ciliary Dyskinesia trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05685186, a study of Primary Ciliary Dyskinesia, is active but no longer recruiting, sponsored by ReCode Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this observational study is to characterize clinical measures and biomarkers of airway disease in adults with primary ciliary dyskinesia (PCD) and in a group of healthy volunteers (HV) to establish normative values. Lung function, mucociliary clearance, radiological findings, and clinical findings will be assessed. Furthermore, quality of life will be assessed using QOL-PCD, a disease specific questionnaire.
Primary Outcome
Descriptive statistical methods will be applied to analyze: lung function, measure % predicated (pp) FEV1. Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 26
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Spirometry
- DIAGNOSTIC_TEST Multiple Breath Washout (MBW)
- DIAGNOSTIC_TEST Mucociliary Clearance (MCC)
- DIAGNOSTIC_TEST CT of the chest
- DIAGNOSTIC_TEST MRI of the chest
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-03-08 |
| Est. Completion | 2025-06-30 |
What the registry record for NCT05685186 still lists
NCT05685186 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 103-participant average among 7 other Primary Ciliary Dyskinesia trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Primary Ciliary Dyskinesia appearing as the primary indexed condition, and to 5 interventions - of which Spirometry is the first listed.
NCT05685186 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05685186 about?
NCT05685186 is a clinical study titled "A Longitudinal, Observational Study of Primary Ciliary Dyskinesia in Adults". The goal of this observational study is to characterize clinical measures and biomarkers of airway disease in adults with primary ciliary dyskinesia (PCD) and in a group of healthy volunteers (HV) to establish normative values. Lung function, mucociliary clearance, radiological findings, and clinica...
What is the current status of trial NCT05685186?
This trial is currently active not recruiting. The enrollment target is 50 participants. The study started on 2023-03-08. Estimated completion is 2025-06-30.
What conditions does trial NCT05685186 study?
This clinical trial studies the following conditions: Primary Ciliary Dyskinesia.
What interventions are being tested in trial NCT05685186?
The interventions under investigation include: Spirometry (DIAGNOSTIC_TEST), Multiple Breath Washout (MBW) (DIAGNOSTIC_TEST), Mucociliary Clearance (MCC) (DIAGNOSTIC_TEST), CT of the chest (DIAGNOSTIC_TEST), MRI of the chest (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05685186?
This trial is sponsored by ReCode Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05685186 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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