Text Size

Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of New Mexico.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01303068
First received: February 14, 2011
Last updated: February 23, 2011
Last verified: February 2011
History of Changes
  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 Phase
Cystic Fibrosis
 Drug: urea
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • 13CO2 gas [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Determine whether aerosolized 13C-urea (10, 20, and 40 mg) to the lungs of 10 patients with CF colonized with P. aeruginosa will result in an elevated level of 13CO2 in exhaled breath at 2 min, 5 min, 10 min and 15 min post inhalation


Estimated Enrollment: 20
Study Start Date: April 2011
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CF patients Drug: urea
urea nebulizer solution
Drug: urea
10, 20 and 40 mg of urea to be nebulized
Drug: urea
10, 20, 40 mg of urea to be nebulized
Drug: urea
10,20 or 40 mg of ureal to be nebulized
Drug: urea
10,20, 40 mg urea to be nebulized
controls
control groups with no P. aeruginosa infection
 Drug: urea
urea nebulizer solution
Drug: urea
10, 20 and 40 mg of urea to be nebulized
Drug: urea
10, 20, 40 mg of urea to be nebulized
Drug: urea
10,20 or 40 mg of ureal to be nebulized

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with CF aged 12 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303068

Locations
United States, New Mexico
University of New Mexico Not yet 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
  More Information

No publications provided

Responsible Party: Hengameh Raissy, Pharm.D., University of New Mexico
ClinicalTrials.gov Identifier: NCT01303068     History of Changes
Other Study ID Numbers: HRRC, xx-2011
Study First Received: February 14, 2011
Last Updated: February 23, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pseudomonas Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 16, 2013