Volatile Organic Compounds in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— VOCCF  

Official title:

Detection of Pulmonary Colonization in Cystic Fibrosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379040
• Other study ID #: CF1
• Status: Completed
• Phase: N/A
• First received: June 21, 2011
• Last updated: August 12, 2014
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2014
• Source: Landon Pediatric Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 40 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Intervention

Other:
• Cystic Fibrosis patients

Locations

Country	Name	City	State
United States	Pediatric Diagnostic Center	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Landon Pediatric Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial Identification	Patient's provided breath samples and sputum for culture. Bacterial identification by indices was achieved	six months	No