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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
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This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.
This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypertonic bicarbonate | Experimental | subjects will be administered a solution of 8.4% hypertonic bicarbonate by nebulizer |
|
| hypertonic saline | Active Comparator | subjects will be administered a solution of 7% sodium chloride by nebulizer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypertonic bicarbonate | Drug | 8.4% sodium bicarbonate inhaled |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled breath condensate pH change | Change in pH after inhalation of two doses on one day | two time points (baseline and four (4) hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Expectorated sputum change | Change in sputum wet-to-dry ratio ratio after inhalation of two doses on one day | two time points (Baseline and four (4) hours) |
| Spirometry | FEV1 before and after inhalation of two doses on one day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph M PIlewski, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Fallk Clinic | Pittsburgh | Pennsylvania | 15213 | United States | ||
| Children's Hospital of Pittsburgh of UPMC |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D008173 | Lung Diseases, Obstructive |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| sodium chloride | Drug | 7% sodium chloride inhaled |
|
|
| two time points (baseline and four (4) hours) |
| Pittsburgh |
| Pennsylvania |
| 15224 |
| United States |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |