Sustained Effects of Hypertonic Saline on Mucociliary Clearance in Subjects With Chronic Bronchitis
| Status: | Completed |
|---|---|
| Conditions: | Bronchitis, Chronic Obstructive Pulmonary Disease, Other Indications, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 6/24/2017 |
| Start Date: | February 2013 |
| End Date: | May 2016 |
Novel Therapies for Muco-Obstructive Lung Diseases: Sustained Effects of Hypertonic Saline on Mucociliary Clearance and Clinical Tolerability 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.
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.
Inclusion Criteria:
Volunteers who meet all of the following criteria will be eligible for study
participation:
1. Age 40-80 years, inclusive
2. Non-pregnant subjects must be either not sexually active, post-menopausal, surgically
sterilized, or agree to use an appropriate "double barrier" method (such as diaphragm
and condom), or must currently be using a prescribed transdermal, injection, implant,
or oral contraceptive during study participation.
3. Forced expiratory volume in 1 second (FEV1) of 35-80% of predicted, inclusive, and
FEV1/forced vital capacity (FVC) < 70%
4. Produces mucus at least 2 days per week, on average
5. History of smoking (≥ 10 pack years) -
Exclusion Criteria:
Volunteers will be excluded from the study if they meet any of the following criteria:
1. Uses oxygen continuously during daytime hours (nighttime use OK)
2. Requires > 10mg per day of prednisone (or equivalent corticosteroid dose) chronically
3. Concomitant presence of congestive heart failure, active coronary syndromes, or other
disease that in the opinion of the investigator would increase the risk resulting
from participation
4. Recent change in respiratory medications, including acute antibiotic or systemic
corticosteroid interventions within the last 4 weeks
5. History of intolerance or hypersensitivity to hypertonic saline or short acting
inhaled beta agonist
6. Significant broncho reactivity by examination or pulmonary function testing (PFT),
that in the opinion of the investigator would increase the risk of HS use
7. Radiation exposure within the 12 months prior to study participation that would cause
them to exceed Federal Regulations by participating in this study
8. Subjects with a positive pregnancy test
9. Subjects who, in the opinion of the Principal Investigator, should not participate in
the study
Subjects may be temporarily excluded from screening should they experience a respiratory
tract infection that requires treatment with antibiotics and/or steroids. They may become
eligible for screening four weeks after completing their treatment providing their
symptoms have resolved.
We found this trial at
1
site
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Ashley G Henderson, MD
Phone: 984-974-2967
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
Click here to add this to my saved trials
