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| ID | Type | Description | Link |
|---|---|---|---|
| 1P01HL108808-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AB: 7% HS home tx, then 0.12% NaCl | Placebo Comparator | Inhaled Inhaled 7% HS (hypertonic saline) home treatment' , then 0.12% sodium chloride solution home treatment. The intervention consists of the subject receiving both concentrations of inhaled sodium chloride solution, each during a different home treatment periods. 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. |
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| BA: 0.12% NaCl home tx, then 7% HS | Placebo Comparator | Subjects randomized to order BA will receive inhaled 0.12% NaCl mist during the first home treatment period, then Inhaled 7% HS home treatment during the second home treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled 7% HS (NaCl) home treatment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Using a gamma camera and inhalation of technicium bound to sulfur colloid, mucus clearance can be measured. Will do this with two different types of inhaled saline. | Approximately 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| We will also be collecting sputum and breath condensation to analyze for protein and inflammatory changes that might occur with exacerbations. | Within 2 years after all data collection has ended |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lung function testing (spirometry) | within 11 weeks of enrollment of subjects |
Inclusion Criteria:
Volunteers who meet all of the following criteria will be eligible for study participation:
Exclusion Criteria:
Volunteers will be excluded from the study if they meet any of the following criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ashley G Henderson, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |