Cystic FibrosisNCT05944367
The Use of Breath Volatile Organic Compounds in Early Detection of Acute Pulmonary Exacerbations in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a single-centre, prospective observational cohort study assessing the potential utility of the Owlstone Medical "Breath Biopsy" in early diagnosis of pulmonary infections in patients with cystic fibrosis (CF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2021to 23 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Cystic Fibrosis who attend Royal Papworth Cystic Fibrosis Centre
Who may be able to join
- Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels
- F508Del homozygous or heterozygous (F508Del with another severe CFTR mutation)
- Age over 18 years
- Able to provide written informed consent
- Current exacerbation requiring inpatient or outpatient treatment at Royal Papworth Hospital.
- Chronic infection with Pseudomonas aeruginosa, as defined as >50% of sputum culture or cough swabs being positive in the preceding 12 months
- Baseline FEV1 30%-with no predicted upper limit
Who cannot join
- Patients unable to provide written informed consent
- Patients whose clinical status precludes use of the ReCIVA (mask) Breath Sampler due to oxygen dependency or tachypnoea
- Patients who require admission to intensive care
- Lung transplant recipients
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Papworth Hospital
Cambridge, Cambridgeshire, CB2 0AA
About this study
Official title: The Use of Breath Volatile Organic Compounds (VOCs) in Early Detection of Acute Pulmonary Exacerbations in Cystic Fibrosis
This is a single-centre, prospective observational cohort study assessing the potential utility of the Owlstone Medical "Breath Biopsy" in early diagnosis of pulmonary infections in patients with cystic fibrosis (CF). In cystic fibrosis pulmonary infections occur frequently and are associated with decline in lung function and disease progression, therefore a cornerstone of CF management is early identification and treatment of infections. "Breath Biopsy" is a non-invasive novel technology that has been trialled extensively in diagnosis of a variety of medical conditions with promising results. The technology is based the identification of a unique profile of organic compounds in exhaled breath of patients with a certain medical condition. Making the diagnosis of pulmonary infections in patients with CF is clinically challenging and at present relies on imprecise diagnostic tests, and generally requires attendance of patients to hospital or clinic for assessment. Ultimately, this research aims to assess the feasibility of incorporating "Breath Biopsy" into this diagnostic pathway with the advantages of both improving diagnostic certainty and potentially allowing in-home diagnosis of infections related to CF. Furthermore, identification of organic compounds implicated in CF infections will improve the understanding of why these infections occur, which to date remains an area that is poorly understood. Five patients with CF-related pulmonary infections admitted to the inpatient CF unit at the Royal Papworth Hospital will be enrolled, and use "Breath Biopsy" devices provided by Owlstone medical to collect breath samples from these patients in order to determine whether a unique organic compound profile can be identified in CF exacerbations.
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of the Owlstone Breath Biopsy System to Detect Change in Volatile Organic Compounds During and After an Acute Pulmonary Exacerbation in Adults with Cystic Fibrosis, Measured by Mass Spectrometry Analysis of the Collected Breath Sample.
Participants will have a breath biopsy taken by breathing into a fitted mask at the start, during, end of an acute pulmonary exacerbation requiring intravenous antibiotics.
Measured: Change from baseline in Volatile Organic Compounds profile at day 1, 7 and 14 of an acute pulmonary exacerbation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start13 Oct 2021
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944367
- Sponsor's protocol ID
- 20/PR/0175
- Status last verified
- May 2025
- First submitted
- 14 Jun 2023
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Breath Volatile Organic Compounds (VOCs) in Early Detection of Acute Pulmonary Exacerbations in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05944367
- Acronym / sponsor ID
- 20/PR/0175
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 13 Jul 2023 (actual)
- 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 is a single-centre, prospective observational cohort study assessing the potential utility of the Owlstone Medical "Breath Biopsy" in early diagnosis of pulmonary infections in patients with cystic fibrosis (CF). In cystic fibrosis pulmonary infections occur frequently and are associated with decline in lung function and disease progression, therefore a cornerstone of CF management is early identification and treatment of infections. "Breath Biopsy" is a non-invasive novel technology that has been trialled extensively in diagnosis of a variety of medical conditions with promising results. The technology is based the identification of a unique profile of organic compounds in exhaled breath of patients with a certain medical condition. Making the diagnosis of pulmonary infections in patients with CF is clinically challenging and at present relies on imprecise diagnostic tests, and generally requires attendance of patients to hospital or clinic for assessment. Ultimately, this research aims to assess the feasibility of incorporating "Breath Biopsy" into this diagnostic pathway with the advantages of both improving diagnostic certainty and potentially allowing in-home diagnosis of infections related to CF. Furthermore, identification of organic compounds implicated in CF infections will improve the understanding of why these infections occur, which to date remains an area that is poorly understood. Five patients with CF-related pulmonary infections admitted to the inpatient CF unit at the Royal Papworth Hospital will be enrolled, and use "Breath Biopsy" devices provided by Owlstone medical to collect breath samples from these patients in order to determine whether a unique organic compound profile can be identified in CF exacerbations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Cystic Fibrosis who attend Royal Papworth Cystic Fibrosis Centre
Key inclusion criteria (7 listed)
- Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels
- F508Del homozygous or heterozygous (F508Del with another severe CFTR mutation)
- Age over 18 years
- Able to provide written informed consent
- Current exacerbation requiring inpatient or outpatient treatment at Royal Papworth Hospital.
Key exclusion criteria (4 listed)
- Patients unable to provide written informed consent
- Patients whose clinical status precludes use of the ReCIVA (mask) Breath Sampler due to oxygen dependency or tachypnoea
- Patients who require admission to intensive care
- Lung transplant recipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The accuracy of the Owlstone Breath Biopsy System to Detect Change in Volatile Organic Compounds During and After an Acute Pulmonary Exacerbation in Adults with Cystic Fibrosis, Measured by Mass Spectrometry Analysis of the Collected Breath Sample.
Time frame: Change from baseline in Volatile Organic Compounds profile at day 1, 7 and 14 of an acute pulmonary exacerbation.
Participants will have a breath biopsy taken by breathing into a fitted mask at the start, during, end of an acute pulmonary exacerbation requiring intravenous antibiotics.
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 29 May 2025.
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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, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 7 inclusion and 4 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 29 May 2025. 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 Kingdom. 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?
The accuracy of the Owlstone Breath Biopsy System to Detect Change in Volatile Organic Compounds During and After an Acute Pulmonary Exacerbation in Adults with Cystic Fibrosis, Measured by Mass Spectrometry Analysis of the Collected Breath Sample. (time frame: Change from baseline in Volatile Organic Compounds profile at day 1, 7 and 14 of an acute pulmonary exacerbation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2025.