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NCT Number: NCT05944367

The Use of Breath Volatile Organic Compounds 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Papworth Hospital

Cambridge, Cambridgeshire, CB2 0AA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Papworth Hospital NHS Foundation Trust

Other Gov

Registry information

Official study title

The Use of Breath Volatile Organic Compounds (VOCs) in Early Detection of Acute Pulmonary Exacerbations in Cystic Fibrosis

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2023
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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