Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: 13C urea breath test Kit

• Registration Number: NCT01303068
• Lead Sponsor: University of New Mexico

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

Study Timeline

• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Study Start: 2012-08-15
• Primary Completion: 2014-08
• Study Completion: 2015-08
• Disposition First Submitted: 2015-12-10
• Disposition First Submitted QC: 2015-12-10
• Disposition First Posted: 2016-01-13
• Results First Submitted: 2020-12-15
• Results First Submitted QC: 2021-02-23
• Results First Posted: 2021-03-16
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CF patients, 13C urea breath test kit	13C urea breath test Kit	CF patients with Pseudomonas infection tested with 13C urea breath test
Healthy controls, 13C urea breath test kit	13C urea breath test Kit	Healthy subjects using 13C urea breath test kit

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States