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Completed

NCT Number: NCT01303068

Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

The purpose of this study is to determine if inhaled urea can be used to detect the presence of Pseudomonas Aeruginosa in the lungs

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

About this study

Dose Escalation study

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

13C urea breath test Kit

Device

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

Primary outcomes

  1. The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation.

    Time frame: 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 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Feb 24, 2011
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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