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.
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.
Chronic Obstructive Pulmonary Disease
Other: Inhaled HS home treatment
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Novel Therapies for Muco-Obstructive Lung Diseases: Sustained Effects of Hypertonic Saline on Mucociliary Clearance and Clinical Tolerability in Subjects With Chronic Bronchitis|
- Measure and compare the sustained effects on mucus clearance of two weeks of daily dosing of hypertonic saline versus a low salt control treatment for subjects with CB. [ Time Frame: Approximately 11 weeks ] [ Designated as safety issue: No ]
- We will also be collecting sputum and breath condensation to analyze for protein and inflammatory changes that might occur with exacerbations. [ Time Frame: Within 2 years after all data collection has ended ] [ Designated as safety issue: No ]
- Changes in lung function testing (spirometry) [ Time Frame: within 11 weeks of enrollment of subjects ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Inhaled HS home treatment
Inhaled 7% sodium chloride solution (NaCl)
Inhaled 0.12% sodium chloride solution (NaCl)
The intervention consists of the subject receiving both concentrations of inhaled sodium chloride solution, each during a different home treatment period. Subjects randomized to order AB will receive inhaled 7% NaCl (sodium chloride solution) mist during the first home treatment period, then 0.12% NaCL during the second home treatment period.
Subjects randomized to order BA will receive inhaled 0.12% NaCl mist during the first home treatment period, then 7% NaCl during the second home treatment period.
Other: Inhaled HS home treatment
Administering inhaled 7% NaCl for two weeks of home treatment vs. a placebo of 0.12% NaCL during a separate home treatment period, and assessing the effects of each primarily by MCC study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792271
|Contact: Fred Fuller, BA ADNfirstname.lastname@example.org|
|Contact: Ashley Henderson, MDemail@example.com|
|United States, North Carolina|
|University of North Carolina Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Fred Fuller, BA ADN 919-966-2531 firstname.lastname@example.org|
|Principal Investigator: Ashley G Henderson, MD|
|Principal Investigator:||Ashley G Henderson, MD||University of North Carolina, Chapel Hill|