Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

University of New Mexico12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

13C urea breath test KitDEVICE

20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of New Mexico

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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