Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

Study Overview
=================
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

Official Title
-----------------
Detection of Pseudomonas. Aeruginosa in the Airways of Patients With Cystic Fibrosis Using of Aerosolized 13C-urea

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Device: 13C urea breath test Kit


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CF patients, 13C urea breath test kit<br>CF patients with Pseudomonas infection tested with 13C urea breath test | Device: 13C urea breath test Kit<br>* 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas<br>|
| Active Comparator: Healthy controls, 13C urea breath test kit<br>Healthy subjects using 13C urea breath test kit | Device: 13C urea breath test Kit<br>* 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 5 minutes post inhalation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CF