N/A N=12 Single-blind Diagnostic

Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

Cystic Fibrosis

Bottom Line

View on ClinicalTrials.gov: NCT01303068 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation. — 0; 0 adverse events

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 13C urea breath test Kit (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of New Mexico
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation.	0; 0	—
SECONDARY 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.	4; 0.8; 10; 2.13	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01303068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.