Volatile Organic Compounds in Cystic Fibrosis

Overview

This experiment is designed to test the effectiveness of a new electronic nose device, which allows a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of bacterial organisms in the lower respiratory tract. It consists of: – A breath collection apparatus for collection of volatile organic compounds in breath onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample of room air. – Analysis of the volatile organic compounds in breath and room air by short acoustic wave/gas chromatography. – Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of lower respiratory tract colonization and infection. This study will test the hypothesis that the investigators can identify the presence of Pseudomonas aeruginosa by sampling the "head space" above culture media of sputum provided by patients with cystic fibrosis. This study will test the additional hypothesis that the investigators can identify the presence of Pseudomonas aeruginosa by sampling exhaled breath from the patient providing the sputum.

Full Title of Study: “Detection of Pulmonary Colonization in Cystic Fibrosis Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2009

Interventions

  • Other: Cystic Fibrosis patients

Arms, Groups and Cohorts

  • Cystic Fibrosis Patients
    • Patients with Cystic Fibrosis, some having Pseudomonas aeruginosa, some not.
  • Control
    • Healthy volunteers

Clinical Trial Outcome Measures

Primary Measures

  • Bacterial Identification
    • Time Frame: six months
    • Patient’s provided breath samples and sputum for culture. Bacterial identification by indices was achieved

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of Cystic Fibrosis – Must be able to give breath and sputum samples Exclusion Criteria:

  • Heavy smoker – Inability to regularly give breath and sputum samples – History of additional pulmonary disease

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Landon Pediatric Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chris Landon, Principal Investigator – Landon Pediatric Foundation

Citations Reporting on Results

http://www.beehive.co.jp/est/samplePDF/CysticFibrosis.pdf

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