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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The purpose of this research study is to learn about how long hypertonic saline (HS) works in healthy subjects. Inhaled hypertonic saline is one of the medications used to treat Cystic Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus builds up in the lungs. Hypertonic saline and other medications currently being developed may help patients with these lung diseases by speeding up mucus clearance from the lung. For these treatments to be effective, they likely need to be able to act for at lease several hours. Investigators are able to measure how lung treatments like hypertonic saline work by conducting a Mucociliary Clearance (MCC) scan. Currently, the investigators do not know how long hypertonic saline works in people who do not have CF. Investigators plan to use this information to improve the design and testing of new treatments for patients with chronic bronchitis.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Hypertonic Saline Effect | Experimental | 2.8% NaCl inhaled 30 minutes before Mucociliary Clearance measured. |
|
| Sustained Hypertonic Saline Effect | Active Comparator | 2.8% NaCl inhaled 4 hours before Mucociliary Clearance measured. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic Saline | Device | 2.8% NaCl x 4ml via nebulizer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Whole Lung Mucociliary Clearance | The primary outcome of mucociliary clearance (MCC) will be depicted by calculating the average rate of isotope clearance (%) from the whole lung compartment, measured for 90 minutes after isotope inhalation (MCC-Ave 90), using data points collected every 10 minutes. Absolute change in MCC-Ave90 from baseline reported for each arm | 30 minutes and 4 hours after inhalation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Donaldson, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypertonic Saline | 2.8% NaCl Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy subjects of any ethnicity between 18-55 years of age, without respiratory or cardiac comorbidities, FEV1 greater than or equal to 80% predicted, FEV1/FVC ratio greater than 70%, non-pregnant female subjects, and subjects who are capable of providing their written informed consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypertonic Saline | 2.8% NaCl Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Whole Lung Mucociliary Clearance | The primary outcome of mucociliary clearance (MCC) will be depicted by calculating the average rate of isotope clearance (%) from the whole lung compartment, measured for 90 minutes after isotope inhalation (MCC-Ave 90), using data points collected every 10 minutes. Absolute change in MCC-Ave90 from baseline reported for each arm | Per Protocol | Posted | Mean | Standard Deviation | % Clearance | 30 minutes and 4 hours after inhalation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acute Hypertonic Saline Effect | 2.8% NaCl inhaled 30 minutes before Mucociliary Clearance measured. Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Donaldson | University of North Carolina Chapel Hill | 919-966-9198 | scott_donaldson@med.unc.edu |
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Subjects completed mucociliary clearance measurements (via gamma scintigraphy) at baseline, 30 minutes after inhaling 2.8% NaCl, and 4 hours after inhaling 2.8% NaCl at separate study visits to characterize acute vs. sustained effects of inhaled 2.8% NaCl on this physiologic process.
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Current Smoker | Count of Participants | Participants |
|
2.8% NaCl Inhaled 4 hours before mucociliary clearance measured Hypertonic saline = 2.8% NaCl x 4 ml delivered via Pari LC STAR jet nebulizer |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Sustained Hypertonic Saline Effect | 2.8% NaCl inhaled 4 hours before Mucociliary Clearance measured. Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer | 0 | 12 | 0 | 12 | 0 | 12 |
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