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Idiopathic Pulmonary FibrosisFIBRINOXNCT04586946

FIBRotic Interstitial Lung Disease and Nocturnal OXygen

An observational study of Idiopathic Pulmonary Fibrosis and Obstructive Sleep Apnea, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Home sleep studies - which allow the measurement of breathing while the person sleeps - will be performed on patients with fibrotic interstitial lung disease attending two of the UK's largest respiratory medicine services.The study will investigate at how symptoms, and breathing and exercise tests differ between these… Read more about this study

Who is it for?
Ages 20 to 90 years
How many people
102 participants
Where
2 sitesUnited Kingdom
Study dates
17 Dec 2018to 30 May 2021
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 20 to 90 years
  • All sexes
  • Adult, Older adult

Study population: Patients with fibrotic interstitial lung disease

Who may be able to join

  • MDT diagnosis of fibrotic interstitial lung disease including but not limited to idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), chronic hypersensitivity pneumonitis (CHP), fibrotic organising pneumonia and unclassifiable fibrotic lung disease.
  • Competent to provide written consent in English

Who cannot join

  • Presence of an underlying connective tissue disease
  • Daytime/resting hypoxaemia with pO2 <8.0
  • Other indication for oxygen therapy
  • 3% ODI >15 events/hour studied or established on CPAP
  • Predominant emphysema on CT
  • Inability to provide informed consent or complete health-related quality of life questionnaires in English
  • Current participation in a research project which might alter lung function or sleep study results

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE19RT

  • Royal Brompton Hospital

    London, sw36np

Other trials in United Kingdom

About this study

Official title: An Observational Study of the Effects of Nocturnal Hypoxaemia on Patients With Fibrotic Interstitial Lung Disease

Home sleep studies - which allow the measurement of breathing while the person sleeps - will be performed on patients with fibrotic interstitial lung disease attending two of the UK's largest respiratory medicine services.The study will investigate at how symptoms, and breathing and exercise tests differ between these two groups after 12 months of study.

Read the detailed description

The interstitial lung diseases are a group of diseases in which patients develop uncontrolled scarring (called fibrosis) within the lung. This causes failure of the lung and patients become progressively more breathless over time. The commonest of these diseases is idiopathic pulmonary fibrosis and this is a devastating condition with a survival of 3-5 years.

Many people with fibrotic interstitial lung diseases have disrupted sleep as well as low oxygen levels at night or obstructive sleep apnoea (OSA - pauses in breathing at night time due to obstruction of the upper airway).

Patients with low oxygen levels at night have a worse quality of life, with fatigue during the day and survive for less long.

102 patients from specialist clinics at Guy's and St Thomas' and the Royal Brompton and Harefield NHS Foundation Trusts will be recruited. This research is funded by a grant from the British Lung Foundation. The investigators aim to compare patients with and without low oxygen levels at night by observing how their disease and quality of life changes over a year.

Patients will be asked to complete a two-night home sleep study which will involve wearing a probe over the finger connected to a sensor on the wrist. Patients will also be provided with a home spirometer to measure their breathing at home daily during the study.

Lung function testing (which is part of normal clinical practice), a six-minute walk test and quality of life questionnaires will be performed at the beginning of the study. These investigations will be repeated at six and twelve months and this will tell us how night time oxygen levels affect the progression of the disease, quality of life, exercise tolerance, hospitalisation frequency and survival of these patients.

Medical subject headings
Idiopathic Pulmonary Fibrosis, Sleep Apnea, Obstructive, Parasomnias

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life measured by King's Brief Interstitial Lung Disease Questionnaire (K-BILD)

    Change in K-BILD score from baseline at 12 months in patients with nocturnal hypoxaemia vs those without (defined as time spent with SpO2<90% of > 10% total sleep time)

    Measured: 0 months,12 months

Secondary outcomes (7)

  1. Forced vital capacity (FVC)

    Annualised decline in FVC in patients with nocturnal hypoxaemia vs those without

    Measured: 12 months

  2. Diffusion capacity of the lung for carbon monoxide (DLCO)

    Change in DLCO from baseline at 6 and 12 months in patients with nocturnal hypoxaemia vs those without

    Measured: 12 months

  3. Pittsburgh Sleep Quality Index (PSQI)

    PSQI score at baseline, and change at 6 and 12 months in patients with nocturnal hypoxaemia vs those without

    Measured: 0 months, 6 months, 12 months

  4. Insomnia Severity Index (ISI)

    ISI score at baseline, and change at 6 and 12 months in patients with nocturnal hypoxaemia vs those without

    Measured: 0 months, 6 months, 12 months

  5. Six-minute walk test (6MWT)

    Total distance (in metres) and minimum oxygen saturation during 6MWT at baseline, 6 and 12 months

    Measured: 0 months 6 months, 12 months

  6. Exacerbation frequency and hospitalisation

    Exacerbation frequency and hospitalisation

    Measured: 12 months

  7. Mortality

    Mortality

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start17 Dec 2018
  3. Primary completion30 May 2021
  4. Study completion30 May 2021

Resources

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
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04586946
Sponsor's protocol ID
Fibrinox 1.0
Acronym
FIBRINOX
Status last verified
Oct 2020
First submitted
17 Dec 2018
Last updated
8 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be collected on paper worksheets filed in the site file and web-based electronic clinical record forms provided by Castor EDC, a secure web database which is compliant with GCP regulations, Annex 11 and 21 CFR part 11. It also complies with EU GDPR. All communication to servers is encrypted using TLS (1.1 or 1.2) through HSTS.

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Pulmonary Fibrosis and Obstructive Sleep Apnea, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites 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 2 inclusion and 7 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 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Quality of life measured by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) (time frame: 0 months,12 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 NCT04586946.

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 8 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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