Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of New Mexico
Sponsor:
Information provided by (Responsible Party):
Hengameh Raissy, Pharm.D., University of New Mexico
ClinicalTrials.gov Identifier:
NCT01303068
First received: February 14, 2011
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Cystic Fibrosis
Device: 13C urea breath test Kit

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Detection of Pseudomonas. Aeruginosa in the Airways of Patients With Cystic Fibrosis Using of Aerosolized 13C-urea

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • The primary objective is to assess the safety of 13C urea administered by inhalation. [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 15
Study Start Date: August 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CF patients, 13C urea breath test kit
CF patients with Pseudomonas infection tested with 13C urea breath test
Device: 13C urea breath test Kit
20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas
Active Comparator: Healthy controls, 13C urea breath test kit
Healthy subjects using 13C urea breath test kit
Device: 13C urea breath test Kit
20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas

Detailed Description:

Dose Escalation study

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303068

Locations
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Franceska Kelly, BS    505-272-9889    fmkelly@salud.unm.edu   
Principal Investigator: Hengameh Raissy, PharmD         
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Hengameh Raissy, PharmD UNM
  More Information

No publications provided

Responsible Party: Hengameh Raissy, Pharm.D., Research Associate Professor, Pediatrics, University of New Mexico
ClinicalTrials.gov Identifier: NCT01303068     History of Changes
Other Study ID Numbers: HRRC, 12-521
Study First Received: February 14, 2011
Last Updated: August 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of New Mexico:
CF

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014