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NCT05740618 · ClinicalTrials.gov registry record · Phase 4
Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT05740618 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 14 participants.
The verdict
NCT05740618, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study will provide important mechanistic information regarding the effect of inhaled mannitol (Bronchitol) in people with cystic fibrosis (PwCF) with moderate to severe disease who are already using elexacaftor/tezacaftor/ivacaftor (E/T/I). Many patients have already discontinued hypertonic saline and other pulmonary therapies because of the profound effect of E/T/I of their symptoms and lung function. Further, because both inhaled osmotic agents (i.e., Bronchitol, hypertonic saline \[HS\]) and E/T/I are believed to exert their beneficial effects through improvements in mucociliary clearance (MCC), it is unknown if the combination of these therapies might be additive or are redundant in a population with moderate to severe disease where bronchiectasis and chronic infection persists, and where eventual decline in lung function is expected over time. This study, therefore, will be the first to determine whether "add on" therapy with inhaled mannitol is able to further accelerate MCC in E/T/I patients. These data would provide some guidance regarding the use of these approved therapies in PwCF.
Interventions
- DRUG Mannitol Inhalant Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-03-28 |
| Est. Completion | 2025-01-29 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05740618
The ClinicalTrials.gov registry entry for NCT05740618 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mannitol Inhalant Product is the first listed.
NCT05740618 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05740618 about?
NCT05740618 is a clinical study titled "Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis". This study will provide important mechanistic information regarding the effect of inhaled mannitol (Bronchitol) in people with cystic fibrosis (PwCF) with moderate to severe disease who are already using elexacaftor/tezacaftor/ivacaftor (E/T/I). Many patients have already discontinued hypertonic sal...
What is the current status of trial NCT05740618?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2023-03-28. Estimated completion is 2025-01-29.
What interventions are being tested in trial NCT05740618?
The interventions under investigation include: Mannitol Inhalant Product (DRUG).
Who is sponsoring clinical trial NCT05740618?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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