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NCT05392855 · ClinicalTrials.gov registry record · NA
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
A NA study, sponsored by University of Missouri-Columbia.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT05392855 is a NA study that was terminated before completion, run by University of Missouri-Columbia. The registered enrollment target is 6 participants.
The verdict
NCT05392855, a NA study, was terminated before completion, sponsored by University of Missouri-Columbia.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
Cystic Fibrosis (CF) is an autosomal recessive disease cause by a mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) manifesting in multiple organs, the most common cause of morbidity and mortality continues to be the pulmonary manifestation. CFTR dysfunction leads to reduced mucociliary clearance, impaired innate immune system function in the lungs (within the airway surface liquid \[ASL\] lining the epithelial barrier of the lungs) and reduced ASL hydration (stickier mucus). To try and help correct this underlying defect patients have been performing airway clearance for decades using different techniques (Percussion and postural drainage \[P\&PD\], Positive expiratory pressure \[PEP\], Oscillatory positive expiratory pressure \[OPEP\], High-frequency chest compression \[HFCC\], exercise), inhaled mucolytics (Hypertonic Saline, Pulmozyme) and inhaled antibiotics. However, performing daily airway clearance can be a large burden on patients and their families with a median number of daily therapies around 7 and average time spent on therapies at almost 2 hours daily. This high treatment burden leads many patients to have reduced adherence to their regimens and multiple studies have shown around 20% of patients performing no daily airway clearance. Since the release of highly effective CFTR modulator therapy patients have experienced improvements in lung function measurements and imaging-based ventilation measurements, reduction in pulmonary exacerbations, and improvement in daily symptom scores. Over 80% of patients and their families and over 95% of clinicians in the United States support the idea of trials looking into the simplification of airway clearance regimens. Combining the inability of most patients to complete their daily regimens, patient and clinician interest in treatment simplification research, and the overwhelming cost of most inhaled medications in cystic fibrosis with the improvement in mucociliary transport and symptoms wi
Interventions
- OTHER Symptom driven performance of airway clearance
- OTHER Continuous daily performance of airway clearance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-09-05 |
| Est. Completion | 2024-09-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05392855
The ClinicalTrials.gov registry entry for NCT05392855 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Symptom driven performance of airway clearance is the first listed.
NCT05392855 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05392855 about?
NCT05392855 is a clinical study titled "Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)". Cystic Fibrosis (CF) is an autosomal recessive disease cause by a mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) manifesting in multiple organs, the most common cause of morbidity and mortality continues to be the pulmonary manifestation. CFTR dysfunction leads to reduced...
What is the current status of trial NCT05392855?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2023-09-05. Estimated completion is 2024-09-18.
What interventions are being tested in trial NCT05392855?
The interventions under investigation include: Symptom driven performance of airway clearance (OTHER), Continuous daily performance of airway clearance (OTHER).
Who is sponsoring clinical trial NCT05392855?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
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