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Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01303068
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hengameh Raissy, Pharm.D., University of New Mexico

Tracking Information
First Submitted Date  ICMJE February 14, 2011
First Posted Date  ICMJE February 24, 2011
Last Update Posted Date February 5, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
13CO2 gas [ Time Frame: 12 months ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
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 ]
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF
Official Title  ICMJE Detection of Pseudomonas. Aeruginosa in the Airways of Patients With Cystic Fibrosis Using of Aerosolized 13C-urea
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Device: 13C urea breath test Kit
20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas
Study Arms  ICMJE
  • Experimental: CF patients, 13C urea breath test kit
    CF patients with Pseudomonas infection tested with 13C urea breath test
    Intervention: Device: 13C urea breath test Kit
  • Active Comparator: Healthy controls, 13C urea breath test kit
    Healthy subjects using 13C urea breath test kit
    Intervention: Device: 13C urea breath test Kit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2015)
12
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2011)
20
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01303068
Other Study ID Numbers  ICMJE HRRC, 12-521
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hengameh Raissy, Pharm.D., University of New Mexico
Study Sponsor  ICMJE University of New Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hengameh Raissy, PharmD UNM
PRS Account University of New Mexico
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP