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NCT01792271 · ClinicalTrials.gov registry record · NA
Sustained Effects of Hypertonic Saline on Mucociliary Clearance in Subjects With Chronic Bronchitis
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT01792271 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 25 participants.
The verdict
NCT01792271, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this research study is to examine the effects of two weeks of daily dosing of inhaled salt water mist (hypertonic saline - HS) on actual measurements of mucociliary and cough clearance in patients with the chronic bronchitis type of Chronic Obstructive Pulmonary Disease (COPD. Defective mucociliary clearance (MCC) is central to the development and/or worsening of several kinds of lung diseases, including COPD/chronic bronchitis (CB), cystic fibrosis (CF), and bronchiectasis. In each case, defective MCC leads to the development of lung infections and damage to the airways from ongoing inflammation caused by a person's inability to clear mucus from the lungs. The investigators' previous studies have shown that the administration of inhaled HS (hypertonic saline) not only acutely accelerates MCC in CF, but also that repetitive use "resets" the baseline rate of MCC within 2 weeks. It is likely that the sustained effect of HS on MCC was responsible for the \~60% reduction in the frequency of pulmonary disease exacerbations, reduced antibiotic use and improved lung function in a long-term study of HS in CF volunteers. As a result, HS has now become a standard therapy for CF lung disease and its success raises optimism that similar benefits might occur in patients with CB. In this study the investigators will use mildly radioactive particles, technetium bound to sulfur colloid, to measure and compare the sustained effects on mucus clearance of two weeks of daily dosing of 7% hypertonic saline versus a low salt control treatment for subjects with CB. We will also be collecting sputum and breath condensation to analyze for protein and inflammatory changes that might occur with exacerbations. Our long term goals are to improve our understanding of MCC in health and disease and to develop better therapies that support and/or restore MCC in patients with these diseases to reduce lung infections.
Interventions
- OTHER Inhaled 7% HS (NaCl) home treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01792271
The ClinicalTrials.gov registry entry for NCT01792271 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 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 Inhaled 7% HS (NaCl) home treatment is the first listed.
NCT01792271 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01792271 about?
NCT01792271 is a clinical study titled "Sustained Effects of Hypertonic Saline on Mucociliary Clearance in Subjects With Chronic Bronchitis". The purpose of this research study is to examine the effects of two weeks of daily dosing of inhaled salt water mist (hypertonic saline - HS) on actual measurements of mucociliary and cough clearance in patients with the chronic bronchitis type of Chronic Obstructive Pulmonary Disease (COPD. Defect...
What is the current status of trial NCT01792271?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2013-02. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01792271?
The interventions under investigation include: Inhaled 7% HS (NaCl) home treatment (OTHER).
Who is sponsoring clinical trial NCT01792271?
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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