Cystic FibrosisVOCCFNCT01379040
Volatile Organic Compounds in Cystic Fibrosis
An observational study of Cystic Fibrosis and Pseudomonas Aeruginosa, run by Landon Pediatric Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Pseudomonas Aeruginosa
- What is being tested?
- Cystic Fibrosis patients
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients will be selected from Dr. Landon's primary care clinic.
Who may be able to join
- Clinical diagnosis of Cystic Fibrosis
- Must be able to give breath and sputum samples
Who cannot join
- Heavy smoker
- Inability to regularly give breath and sputum samples
- History of additional pulmonary disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Diagnostic Center
Ventura, California, 93003
About this study
Official title: Detection of Pulmonary Colonization in Cystic Fibrosis Patients
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
- Being tested
- Cystic Fibrosis patients
- Keywords
- Cystic Fibrosis, Pseudomonas aeruginosa, Volatile Organic Compounds, Electronic nose, Gas Chromatography
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystic Fibrosis patientsOther
| Study group | Role | What they receive |
|---|---|---|
| Cystic Fibrosis Patients | Patients with Cystic Fibrosis, some having Pseudomonas aeruginosa, some not. Receives: Other: Cystic Fibrosis patients | |
| Control | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Identification
Patient's provided breath samples and sputum for culture. Bacterial identification by indices was achieved
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landon Pediatric Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris Landon, Landon Pediatric Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379040
- Sponsor's protocol ID
- CF1
- Acronym
- VOCCF
- Status last verified
- Aug 2014
- First submitted
- 21 Jun 2011
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
http://www.beehive.co.jp/est/samplePDF/CysticFibrosis.pdf
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Pulmonary Colonization in Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT01379040
- Acronym / sponsor ID
- VOCCF / CF1
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa
- Keywords
- Cystic Fibrosis, Pseudomonas aeruginosa, Volatile Organic Compounds, Electronic nose, Gas Chromatography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Landon Pediatric FoundationUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis Patients | – | Other: Cystic Fibrosis patientsPatients with Cystic Fibrosis, some having Pseudomonas aeruginosa, some not. |
| Control | – | –Healthy volunteers |
Who may qualify
- Ages
- 1 year to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients will be selected from Dr. Landon's primary care clinic.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Cystic Fibrosis
- Must be able to give breath and sputum samples
Key exclusion criteria (3 listed)
- Heavy smoker
- Inability to regularly give breath and sputum samples
- History of additional pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cystic Fibrosis patients | Other | Cystic Fibrosis Patients |
Primary outcome
Bacterial Identification
Time frame: six months
Patient's provided breath samples and sputum for culture. Bacterial identification by indices was achieved
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Results publicationhttp://www.beehive.co.jp/est/samplePDF/CysticFibrosis.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Pseudomonas Aeruginosa, run by Landon Pediatric Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Identification (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01379040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.