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The purpose of this study is to determine if inhaled urea can be used to detect the presence of Pseudomonas Aeruginosa in the lungs
Dose Escalation study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CF patients, 13C urea breath test kit | Experimental | CF patients with Pseudomonas infection tested with 13C urea breath test |
|
| Healthy controls, 13C urea breath test kit | Active Comparator | Healthy subjects using 13C urea breath test kit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13C urea breath test Kit | Device | 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation. | The primary endpoint is the safety of inhaled 13C urea assessed by adverse events including pulmonary findings and changes from baseline in physical examination findings, pulse oximetry results, pulmonary function test results, and vital signs. | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Objective is to Assess the Kinetics of 13C Carbon Dioxide Production by Measuring the Isotopic Ratio of 13C to 12C in Exhaled Carbon Dioxide. | Secondary endpoints are the isotopic ratios of 13C to 12C in exhaled carbon dioxide measured with the POCone detector (Meretek Diagnostics Group of Otsuka America Pharmaceutical, Rockville, MD) at 5, 10, and 15 minutes after study drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hengameh Raissy, PharmD | UNM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CF Patients, 13C Urea Breath Test Kit | CF patients with Pseudomonas infection tested with 13C urea breath test 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas |
| FG001 | Healthy Subjects Using 13C Urea Breath Test Kit | Healthy subjects using 13C urea breath test kit 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CF Patients, 13C Urea Breath Test Kit | CF patients with Pseudomonas infection tested with 13C urea breath test 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas |
| BG001 | Healthy Controls, 13C Urea Breath Test Kit |
| 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 | The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation. | The primary endpoint is the safety of inhaled 13C urea assessed by adverse events including pulmonary findings and changes from baseline in physical examination findings, pulse oximetry results, pulmonary function test results, and vital signs. | Posted | Number | adverse events | 6 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 | CF Patients, 13C Urea Breath Test Kit | CF patients with Pseudomonas infection tested with 13C urea breath test 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hengameh Raissy | University of New Mexico | 5052725484 | hraissy@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 29, 2012 | Jan 26, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 29, 2012 | Jan 26, 2024 | ICF_001.pdf |
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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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| 5 minutes post inhalation |
Healthy subjects using 13C urea breath test kit 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | The Secondary Objective is to Assess the Kinetics of 13C Carbon Dioxide Production by Measuring the Isotopic Ratio of 13C to 12C in Exhaled Carbon Dioxide. | Secondary endpoints are the isotopic ratios of 13C to 12C in exhaled carbon dioxide measured with the POCone detector (Meretek Diagnostics Group of Otsuka America Pharmaceutical, Rockville, MD) at 5, 10, and 15 minutes after study drug administration. | CF patients with infection has a higher 13C urea in their exhaled breath. | Posted | Mean | Full Range | ratio | 5 minutes post inhalation |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Healthy Subjects Using 13C Urea Breath Test Kit | Healthy subjects using 13C urea breath test kit 13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas | 0 | 6 | 0 | 6 | 0 | 6 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| 50 mg |
|
|