Volatile Organic Compounds in Cystic Fibrosis

NCT01379040 | Completed

• 1 other identifier: CF1
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Pseudomonas Aeruginosa

Keywords

Cystic Fibrosis; Pseudomonas aeruginosa; Volatile Organic Compounds; Electronic nose; Gas Chromatography

Outcome Measures

Primary Outcomes (1)

• Bacterial Identification

  Patient's provided breath samples and sputum for culture. Bacterial identification by indices was achieved

  six months

Study Arms (2)

Cystic Fibrosis Patients

Patients with Cystic Fibrosis, some having Pseudomonas aeruginosa, some not.

Other: Cystic Fibrosis patients

Control

Healthy volunteers

Interventions

Cystic Fibrosis patients OTHER

Cystic Fibrosis Patients

Eligibility Criteria

• Age: 1 Year - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from Dr. Landon's primary care clinic.

You may qualify if:

• Clinical diagnosis of Cystic Fibrosis
• Must be able to give breath and sputum samples

You may not qualify if:

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

Sponsors & Collaborators

• Landon Pediatric Foundation: lead

Study Sites (1)

Pediatric Diagnostic Center

Ventura, California, 93003, United States

Location

Related Publications (1)

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

  RESULT

MeSH Terms

Conditions

Cystic Fibrosis; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 23, 2011
• Study Start: August 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

US (1)