Study to investigate longitudinal changes in breath biomarkers in idiopathic pulmonary fibrosis
| ISRCTN | ISRCTN18106574 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18106574 |
| Secondary identifying numbers | BI 1199-0311 |
- Submission date
- 26/07/2018
- Registration date
- 17/09/2018
- Last edited
- 15/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Idiopathic pulmonary fibrosis (IPF) is a chronic lung condition associated with poor prognosis and an average life expectancy worse than most cancers. Effective treatment which slows the progression of IPF has recently become available but it is costly and at present is limited to patients who meet specific criteria based on their breathing tests. The breathing tests currently available to monitor progression of the disease are not always reliable and do not predict which patients will respond to treatment. The aim of this study is to use a technique which analyses breath samples to provide a profile of the chemicals which are present in the exhaled breath of patients with IPF. The researchers want to know whether this breath profile differs between patients with IPF depending on the severity of their disease. They also want to know whether the breath profile changes over time and whether this can be used to predict which patients are likely to have rapid progression of their disease. It is hoped that this will provide an accurate way of monitoring the disease and predicting progression. They also plan to look at the breath profile of patients receiving specific disease modifying treatment for IPF to see whether breath analysis can predict which patients will respond to treatment.
Who can participate?
Patients aged 18 and over with IPF
What does the study involve?
Participants attend 4 visits at 3 month intervals to provide breath samples, blood samples and complete a questionnaire. Breath is collected using a device called the ReCIVA (Owlstone Medical, Cambridge, UK). This is a mask which holds four steel tubes containing material which collects breath. Participants breathe into the mask for about 8 minutes. The tubes are transported to a laboratory where the breath samples are analysed.
What are the possible benefits and risks of participating?
The study will not provide specific individual benefit to the participants involved but will help to progress the understanding of IPF and could help to improve management of the condition in the long term. There are no specific risks associated with breath sampling. Sampling requires the use of a face mask which some patients may find uncomfortable, and in the unlikely event that this is the case they will be permitted to stop sampling immediately.
Where is the study run from?
1. Wythenshawe Hospital, Manchester University NHS Foundation Trust (UK)
2. Norfolk and Norwich University Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
February 2017 to July 2020
Who is funding the study?
Boehringer Ingelheim (Germany)
Who is the main contact?
Dr Conal Hayton
Contact information
Public
North West Lung Centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
 ORCID ID |
0000-0001-8907-0643 |
|---|
Study information
| Study design | Observational longitudinal cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Available at www.ipfvoc.org |
| Scientific title | A pilot study to investigate longitudinal changes in breath biomarkers in idiopathic pulmonary fibrosis |
| Study acronym | IPF VOC |
| Study hypothesis | Patients with idiopathic pulmonary fibrosis have different breath profiles based on the severity of their disease. |
| Ethics approval(s) | Wales Research Ethics Committee 6, 27/11/2017, IRAS Project ID: 227743, HRA approval 10/05/2018 |
| Condition | Idiopathic pulmonary fibrosis |
| Intervention | 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 (Owlstone Medical, Cambridge, UK). This is a mask which holds 4 steel tubes containing absorbent material which collect breath. Participants will breathe into the mask for approximately 8 minutes. The tubes will be transported to a laboratory where the breath samples will be analysed using a mass spectrometer to identify volatile organic compounds (VOCs). Breath samples will be taken on each of the visits (maximum of 5 samples). There is also an option to provide serum samples on each visit, which will be stored for later use. |
| Intervention type | Other |
| Primary outcome measure | Volatile Organic Compounds, measured using mass spectrometry, that can distinguish between IPF patients based on their baseline GAP stage (I, II or III) |
| Secondary outcome measures | 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 <5%), slow decliners (relative FVC decline 5-10%), fast 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 |
| Overall study start date | 01/02/2017 |
| Overall study end date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 88 |
| Participant inclusion criteria | 1. Age ≥ 18 2. Multi-disciplinary team diagnosis of idiopathic pulmonary fibrosis as per international consensus guidelines |
| Participant 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 |
| Recruitment start date | 09/07/2018 |
| Recruitment end date | 30/06/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Wythenshawe
Manchester
M23 9LT
United Kingdom
Norwich
NR4 7UY
United Kingdom
Sponsor information
Hospital/treatment centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
England
United Kingdom
"ROR" |
https://ror.org/00he80998 |
|---|
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Boehringer Ingelheim International GmbH
- Location
- Germany
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Protocol will be made available via www.ipfvoc.org. The trialists aim to publish this study in a peer-reviewed scientific journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Conal Hayton. Type of data – all data anonymised, demographic, clinical and VOC data. Data will become available once all primary analysis completed (expected to be 6 months after last participant completes study). Data will be available for 12 months. Data will be available for non-commercial research. |
Editorial Notes
15/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/07/2019 to 30/06/2019.
2. The total final enrolment number was added.
24/06/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2019 to 31/07/2019.
2. The overall trial end date was changed from 31/07/2020 to 31/12/2020.
3. The intention to publish date was changed from 31/07/2021 to 31/12/2021.
09/05/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2019 to 31/05/2019.
2. The overall trial end date was changed from 31/05/2020 to 31/07/2020.
3. The intention to publish date was changed from 31/05/2021 to 31/07/2021.
21/02/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2019 to 30/04/2019.
2. The overall trial end date was changed from 01/01/2020 to 31/05/2020.
3. The intention to publish date was changed from 01/01/2021 to 31/05/2021.
