Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

University of New Mexico (UNM)

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Device: 13C urea breath test Kit

Study type: Interventional

Funder types: Other

Identifiers

NCT01303068

HRRC, 12-521

Details and patient eligibility

About

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

Full description

Dose Escalation study

Enrollment: 12 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

CF patients, 13C urea breath test kit

Experimental group

Description:

CF patients with Pseudomonas infection tested with 13C urea breath test

Treatment:

Device: 13C urea breath test Kit

Healthy controls, 13C urea breath test kit

Active Comparator group

Description:

Healthy subjects using 13C urea breath test kit

Treatment:

Device: 13C urea breath test Kit