Study to investigate longitudinal changes in breath biomarkers in idiopathic pulmonary fibrosis

A pilot study to investigate longitudinal changes in breath biomarkers in idiopathic pulmonary fibrosis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN18106574

Enrollment

Registered

2018-09-17

Start date

2018-07-09

Completion date

Unknown

Last updated

2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis Respiratory Other interstitial pulmonary diseases with fibrosis

Interventions

This is an observational study involving the collection of clinical data, 2 breathlessness questionnaires and exhaled breath samples. Breath will be collected using a device called the ReCIVA (Owlston

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 2. Multi-disciplinary team diagnosis of idiopathic pulmonary fibrosis as per international consensus guidelines

Exclusion criteria

Exclusion criteria: 1. Significant respiratory co-morbidity (i.e. where the major respiratory diagnosis is not IPF) 2. FEV1/FVC ratio < 70% on full lung function testing 3. Residual volume = 90 % predicted on full lung function testing 4. Current smoker 5. Received treatment for acute lower respiratory tract infection with last 4 weeks 6. Unwilling to participate in the study

Design outcomes

Primary

Measure	Time frame
Volatile Organic Compounds, measured using mass spectrometry, that can distinguish between IPF patients based on their baseline GAP stage (I, II or III)	—

Secondary

Measure	Time frame
1. Volatile Organic Compounds, measured using mass spectrometry, that can distinguish between patients based on change in FVC after 12 months [defined as non-decliners (relative FVC decline 10%)] 2. Volatile Organic Compounds, measured using mass spectrometry, which can distinguish between patients with an increase in MRC dyspnoea score of 1 or more after 12 months and those without a change 3. Volatile Organic Compounds, measured using mass spectrometry, that can distinguish between patients with an increase in USCD SOBQ scores of 5 or more after 12 months compared to those without a change 4. Volatile Organic Compounds, measured using mass spectrometry, that can distinguish between patients that respond to antifibrotic treatments and those that do not (response defined as less than 10% in relative FVC decline at 12 months) 5. Volatile Organic Compounds, measured using mass spectrometry, that can distinguish between patients having an exacerbation of IPF and those who are not	—

Measure

Time frame

1. Volatile Organic Compounds, measured using mass spectrometry, that can distinguish between patients based on change in FVC after 12 months [defined as non-decliners (relative FVC decline 10%)] 2. Volatile Organic Compounds, measured using mass spectrometry, which can distinguish between patients with an increase in MRC dyspnoea score of 1 or more after 12 months and those without a change 3. Volatile Organic Compounds, measured using mass spectrometry, that can distinguish between patients with an increase in USCD SOBQ scores of 5 or more after 12 months compared to those without a change 4. Volatile Organic Compounds, measured using mass spectrometry, that can distinguish between patients that respond to antifibrotic treatments and those that do not (response defined as less than 10% in relative FVC decline at 12 months) 5. Volatile Organic Compounds, measured using mass spectrometry, that can distinguish between patients having an exacerbation of IPF and those who are not

—

Countries

United Kingdom

Contacts

Public ContactConal Hayton

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026