Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

NCT01303068 | Completed Results

• 1 other identifier: HRRC, 12-521
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Cystic Fibrosis

Keywords

CF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

CF patients, 13C urea breath test kit

EXPERIMENTAL

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

Device: 13C urea breath test Kit

Healthy controls, 13C urea breath test kit

ACTIVE COMPARATOR

Healthy subjects using 13C urea breath test kit

Device: 13C urea breath test Kit

Interventions

13C urea breath test Kit DEVICE

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

CF patients, 13C urea breath test kit; Healthy controls, 13C urea breath test kit

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with CF aged 18 years and above colonized with P. aeruginosa
• Normal subjects ages 18 and above without CF or p. aeruginosa

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Hengameh Raissy
• Organization: University of New Mexico

hraissy@salud.unm.edu

5052725484

Study Officials

• Hengameh Raissy, PharmD

  UNM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor, Pediatrics

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 24, 2011
• Study Start: August 15, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2015
• Last Updated: January 30, 2024
• Results First Posted: March 16, 2021

Record last verified: 2024-01

Locations

US (1)