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Volatile Organic Compounds in Cystic Fibrosis (VOCCF)

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ClinicalTrials.gov Identifier: NCT01379040
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Chris Landon, Landon Pediatric Foundation

Brief Summary:

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.


Condition or disease Intervention/treatment
Cystic Fibrosis Pseudomonas Aeruginosa Other: Cystic Fibrosis patients

Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Pulmonary Colonization in Cystic Fibrosis Patients
Study Start Date : August 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
Cystic Fibrosis Patients
Patients with Cystic Fibrosis, some having Pseudomonas aeruginosa, some not.
Other: Cystic Fibrosis patients
Control
Healthy volunteers



Primary Outcome Measures :
  1. Bacterial Identification [ Time Frame: six months ]
    Patient's provided breath samples and sputum for culture. Bacterial identification by indices was achieved



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Ages Eligible for Study:   1 Year to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected from Dr. Landon's primary care clinic.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379040


Locations
United States, California
Pediatric Diagnostic Center
Ventura, California, United States, 93003
Sponsors and Collaborators
Landon Pediatric Foundation

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

Responsible Party: Chris Landon, Principal Investigator, Landon Pediatric Foundation
ClinicalTrials.gov Identifier: NCT01379040     History of Changes
Other Study ID Numbers: CF1
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

Keywords provided by Chris Landon, Landon Pediatric Foundation:
Cystic Fibrosis
Pseudomonas aeruginosa
Volatile Organic Compounds
Electronic nose
Gas Chromatography

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pseudomonas Infections
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections