NCT01303068
Completed
Not Applicable
Detection of Pseudomonas. Aeruginosa in the Airways of Patients With Cystic Fibrosis Using of Aerosolized 13C-urea
ConditionsCystic Fibrosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis
- Sponsor
- University of New Mexico
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Investigators
Hengameh Raissy, Pharm.D.
Research Associate Professor, Pediatrics
University of New Mexico
Eligibility 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
Outcomes
Primary Outcomes
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
- 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 Sites (1)
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