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Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
13C urea breath test Kit
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cystic Fibrosis focused on measuring CF

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of New Mexico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CF patients, 13C urea breath test kit

Healthy controls, 13C urea breath test kit

Arm Description

CF patients with Pseudomonas infection tested with 13C urea breath test

Healthy subjects using 13C urea breath test kit

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 14, 2011
Last Updated
April 19, 2021
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01303068
Brief Title
Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF
Official Title
Detection of Pseudomonas. Aeruginosa in the Airways of Patients With Cystic Fibrosis Using of Aerosolized 13C-urea
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
CF

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CF patients, 13C urea breath test kit
Arm Type
Experimental
Arm Description
CF patients with Pseudomonas infection tested with 13C urea breath test
Arm Title
Healthy controls, 13C urea breath test kit
Arm Type
Active Comparator
Arm Description
Healthy subjects using 13C urea breath test kit
Intervention Type
Device
Intervention Name(s)
13C urea breath test Kit
Intervention Description
20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas
Primary Outcome Measure Information:
Title
The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation.
Description
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 Outcome Measure Information:
Title
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.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hengameh Raissy, PharmD
Organizational Affiliation
UNM
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

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