Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-15

Study Completion Date

2015-08-31

Brief Summary

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

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Detailed Description

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Dose Escalation study

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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CF patients, 13C urea breath test kit

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

Group Type EXPERIMENTAL

13C urea breath test Kit

Intervention Type DEVICE

20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas

Healthy controls, 13C urea breath test kit

Healthy subjects using 13C urea breath test kit

Group Type ACTIVE_COMPARATOR

13C urea breath test Kit

Intervention Type DEVICE

20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas

Interventions

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13C urea breath test Kit

20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes