Cystic Fibrosis
Conditions
Keywords
CF
Brief summary
The purpose of this study is to determine if inhaled urea can be used to detect the presence of Pseudomonas Aeruginosa in the lungs
Detailed description
Dose Escalation study
Interventions
DEVICE13C urea breath test Kit
20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas
Sponsors
University of New Mexico
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with CF aged 18 years and above colonized with P. aeruginosa * Normal subjects ages 18 and above without CF or p. aeruginosa
Exclusion criteria
* for patients and volunteers will include the presence of asthma, allergic rhinitis, pregnancy, a history of gastric or duodenal ulcer, smoking, and a baseline FEV1 less than 60% of predicted normal value and a pulmonary exacerbation within the last 2 weeks as defined by use of systemic antibiotic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation. | 6 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 5 minutes post inhalation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| Healthy Controls, 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 | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | CF Patients, 13C Urea Breath Test Kit | Healthy Controls, 13C Urea Breath Test Kit | Total |
|---|---|---|---|
| Age, Continuous | 26 years | 32 years | 29 years |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: 6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CF Patients, 13C Urea Breath Test Kit | The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation. | 0 adverse events |
| Healthy Subjects Using 13C Urea Breath Test Kit | The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation. | 0 adverse events |
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.
Time frame: 5 minutes post inhalation
Population: CF patients with infection has a higher 13C urea in their exhaled breath.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CF Patients, 13C Urea Breath Test Kit | 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. | 20 mg | 4 ratio |
| CF Patients, 13C Urea Breath Test Kit | 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. | 50 mg | 10 ratio |
| Healthy Subjects Using 13C Urea Breath Test Kit | 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. | 20 mg | 0.8 ratio |
| Healthy Subjects Using 13C Urea Breath Test Kit | 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. | 50 mg | 2.13 ratio |