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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL108962-01 | 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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Our aims were to determine if exhaled breath condensate (EBC) could detect differences in ion regulation between cystic fibrosis (CF) and healthy and measure the effect of the albuterol on EBC ions in these populations. We hypothesized EBC chloride and sodium would be lower in CF patients at baseline and that albuterol would decrease EBC sodium and increase EBC chloride.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albuterol | Experimental | 2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer |
|
| Saline (healthy only) | Placebo Comparator | nebulized 3 ml normal saline using a Power Neb2 nebulizer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol | Drug | 2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled Sodium (mmol/L) | We collected exhaled breath condensate (EBC) samples, with subjects breathing on a Jaeger EcoScreen for 20 minutes. EBC samples were collected in cystic fibrosis and healthy subjects before and 30-, 60-, and 90-minutes following albuterol administration. | up to 90-minutes post albuterol |
| Net Exhaled Chloride | The calculation of net chloride efflux was used to account for the paracellular reabsorption of Cl- that will follow the reabsorption of Na+ to maintain electroneutral ion flux. Thus, the net chloride efflux calculation used was the gross chloride concentration plus the absolute value of the percent change in sodium from baseline multiplied by the gross chloride concentration for each time point: Net Cl- efflux - [Cl- X-min post] + (([Na+ X-min post]-[Na+Baseline])/ [Na+Baseline]) x [Cl- X-min post]) | baseline to 90 minutes post albuterol administration |
| Measure | Description | Time Frame |
|---|---|---|
| Diffusion Capacity of the Lungs for Carbon Monoxide | Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects. |
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Inclusion Criteria:
Healthy subjects:
CF subjects:
Exclusion Criteria:
Healthy subjects will be excluded if:
CF subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne J Morgan, MD | Department of Pediatrics- Pulmonology, Allergy and Immunology, University of Arizona, Tucson, Arizona | Principal Investigator |
| Cori M Daines, MD | Department of Pediatrics- Pulmonology, Allergy and Immunology, University of Arizona, Tucson, Arizona | Principal Investigator |
| Eric M Snyder, PhD | Department of Pharmacy Practice and Science, University of Arizona, Tucson, Arizona | Principal Investigator |
| Hanna Phan, PharmD | Department of Pharmacy Practice and Science, University of Arizona, Tucson, Arizona | Principal Investigator |
| Asad Patanwalla, PharmD | Department of Pharmacy Practice and Science, University of Arizona, Tucson, Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pharmacy Practice and Science, University of Arizona, Tucson, Arizona | Tucson | Arizona | 85721 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21889619 | Result | Foxx-Lupo WT, Wheatley CM, Baker SE, Cassuto NA, Delamere NA, Snyder EM. Genetic variation of the alpha subunit of the epithelial Na+ channel influences exhaled Na+ in healthy humans. Respir Physiol Neurobiol. 2011 Dec 15;179(2-3):205-11. doi: 10.1016/j.resp.2011.08.008. Epub 2011 Aug 26. | |
| 21893217 | Result | Baker SE, Wheatley CM, Cassuto NA, Foxx-Lupo WT, Sprissler R, Snyder EM. Genetic variation of alphaENaC influences lung diffusion during exercise in humans. Respir Physiol Neurobiol. 2011 Dec 15;179(2-3):212-8. doi: 10.1016/j.resp.2011.08.007. Epub 2011 Aug 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy | Healthy control subjects |
| FG001 | Cystic Fibrosis | Patients diagnosed with cystic fibrosis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy | Healthy Control subjects |
| BG001 | Cystic Fibrosis | Patients diagnosed with cystic fibrosis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Exhaled Sodium (mmol/L) | We collected exhaled breath condensate (EBC) samples, with subjects breathing on a Jaeger EcoScreen for 20 minutes. EBC samples were collected in cystic fibrosis and healthy subjects before and 30-, 60-, and 90-minutes following albuterol administration. | Posted | Mean | Standard Deviation | mmol/L | up to 90-minutes post albuterol |
|
Within the study visit (~2 hours)
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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 | Healthy | Healthy control subjects |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney Wheatley | University of Arizona | 507-266-2696 | wheatley.courtney@mayo.edu |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo saline |
| Drug |
nebulized 3mL normal saline) using a Power Neb2 nebulizer |
|
| baseline, 30-, 60- and 90-minutes post albuterol administration |
| Diffusion Capacity of the Lungs for Nitric Oxide | Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects. | baseline, 30-, 60- and 90-minutes post albuterol administration |
| Peripheral Oxygen Saturation | A finger pulse oximeter allowed for the measurement of peripheral oxygen saturation at baseline, 30-, 60- and 90-minutes post albuterol in cystic fibrosis and healthy subjects. | baseline, 30-, 60- and 90-minutes post albuterol |
| 21050829 | Result | Wheatley CM, Foxx-Lupo WT, Cassuto NA, Wong EC, Daines CL, Morgan WJ, Snyder EM. Impaired lung diffusing capacity for nitric oxide and alveolar-capillary membrane conductance results in oxygen desaturation during exercise in patients with cystic fibrosis. J Cyst Fibros. 2011 Jan;10(1):45-53. doi: 10.1016/j.jcf.2010.09.006. Epub 2010 Nov 2. |
| 21703359 | Result | Traylor BR, Wheatley CM, Skrentny TT Jr, Foxx-Lupo WT, Phan H, Patanwala AE, Morgan WJ, Daines CL, Sprissler R, Snyder EM. Influence of genetic variation of the beta2-adrenergic receptor on lung diffusion in patients with cystic fibrosis. Pulm Pharmacol Ther. 2011 Oct;24(5):610-6. doi: 10.1016/j.pupt.2011.06.001. Epub 2011 Jun 15. |
| 21923601 | Result | Snyder EM, Wong EC, Foxx-Lupo WT, Wheatley CM, Cassuto NA, Patanwala AE. Effects of an inhaled beta2-agonist on cardiovascular function and sympathetic activity in healthy subjects. Pharmacotherapy. 2011 Aug;31(8):748-56. doi: 10.1592/phco.31.8.748. |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| BMI (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
| BSA (m2) | Mean | Standard Deviation | m2 |
|
| VO2 peak (% predicted) | Mean | Standard Deviation | percent predicted |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Diffusion Capacity of the Lungs for Carbon Monoxide | Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects. | Posted | Mean | Standard Deviation | mL/min/mmHg | baseline, 30-, 60- and 90-minutes post albuterol administration |
|
|
|
| Secondary | Diffusion Capacity of the Lungs for Nitric Oxide | Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects. | Posted | Mean | Standard Deviation | mL/min/mmHg | baseline, 30-, 60- and 90-minutes post albuterol administration |
|
|
|
| Primary | Net Exhaled Chloride | The calculation of net chloride efflux was used to account for the paracellular reabsorption of Cl- that will follow the reabsorption of Na+ to maintain electroneutral ion flux. Thus, the net chloride efflux calculation used was the gross chloride concentration plus the absolute value of the percent change in sodium from baseline multiplied by the gross chloride concentration for each time point: Net Cl- efflux - [Cl- X-min post] + (([Na+ X-min post]-[Na+Baseline])/ [Na+Baseline]) x [Cl- X-min post]) | Posted | Mean | Standard Deviation | mmol/L | baseline to 90 minutes post albuterol administration |
|
|
|
| Secondary | Peripheral Oxygen Saturation | A finger pulse oximeter allowed for the measurement of peripheral oxygen saturation at baseline, 30-, 60- and 90-minutes post albuterol in cystic fibrosis and healthy subjects. | Posted | Mean | Standard Deviation | percent of oxygenated hemoglobin | baseline, 30-, 60- and 90-minutes post albuterol |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Cystic Fibrosis | Patients diagnosed with cystic fibrosis | 0 | 16 | 0 | 16 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| 60 minutes post |
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| 90 minutes post |
|
| 60 minutes post |
|
| 90 minutes post |
|
| 60 minutes post |
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| 90 minutes post |
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| 60 minutes post |
|
| 90 minutes post |
|