Interstitial Lung DiseaseFIBRINOX-EXTRANCT06416163
FIBRotic Interstitial Lung Disease With Nocturnal hypOXaemia and EXercise Induced desaTuRAtion
An observational study of Interstitial Lung Disease and Fibrosis Lung, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is an observational clinical research study investigating patients with fibrotic interstitial lung disease (fILD), also known as pulmonary fibrosis. It is not known why some patients with fILD clinically deteriorate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Fibrosis Lung, Pulmonary Hypertension
- What is being tested?
- Prospective
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2024to 1 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with a tertiary ILD centre diagnosis of fibrotic interstitial lung disease
Who may be able to join
- Patients aged 18 year and over
- Tertiary MDT diagnosis of FILD with >10% fibrosis on CT chest as determined by the investigator. Underlying diagnoses to include but not limited to: idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), chronic hypersensitivity pneumonitis (CHP), connective tissue disease-related interstitial lung disease (CTD-ILD), fibrotic organising pneumonia (FOP) and pulmonary sarcoidosis.
- Able to provide informed written consent
Who cannot join
- The use of or any indication for long-term oxygen therapy (LTOT)
- Known moderate or severe obstructive sleep apnoea with an apnoea/hypopnoea index (AHI) or oxygen desaturation index (ODI) over 15 events per hour
- Radiological predominance of emphysema compared with fibrosis on CT chest
- Inability to complete all health status questionnaires as set out in this protocol, with appropriate support
- A confirmed diagnosis of pulmonary hypertension
- Significant cardiovascular comorbidity including severe, uncontrolled hypertension, uncontrolled arrhythmia, recent acute coronary syndrome within 30 days prior to study enrolment, that could mean exercise testing poses a risk to patient health, in the opinion of the investigator
- Musculoskeletal comorbidity that will preclude the participant's ability to reliably complete the complete 6-minute walk test (6MWT)
- Participation in another research project which may confound this study's research findings
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT
About this study
Official title: A Prospective Observational Study Investigating Whether Nocturnal Hypoxaemia and Exercise Induced Desaturation Predict Functional Deterioration in Patients With Fibrotic Interstitial Lung Disease
This is an observational clinical research study investigating patients with fibrotic interstitial lung disease (fILD), also known as pulmonary fibrosis.
It is not known why some patients with fILD clinically deteriorate. This study will investigate whether measuring oxygen levels during sleep or exercise can help identify patients who are at increased risk of clinical deterioration.
Read the detailed description
This work will build upon the FIBRINOX study, previous clinical research conducted by the Guy's and St Thomas' ILD research team. The FIBRINOX study showed that patients with fILD and normal oxygen saturations at rest, but who desaturate whilst asleep or during exercise, have a significantly increased mortality and greater reduction in quality of life compared to patients who do not desaturate at night or during exercise.
The reasons for these differences in mortality and health related quality of life are not known. Data suggests that worsening fILD and the development of pulmonary hypertension, a condition characterised by increased pressure in the pulmonary arteries that is associated with poorer outcomes, may be playing a role.
This clinical research study will recruit approximately 160 patients with a tertiary ILD centre diagnosis of fibrotic interstitial lung disease (fILD). Data from routinely performed investigations as part of tertiary ILD assessment will be systematically recorded.
Investigations will include lung function tests, echocardiography, blood tests, a 6-minute walk test and overnight oximetry. Participants will also complete several quality-of-life questionnaires. These investigations will be performed at baseline, and again at 12 months, with all tests also repeated at 6 months except for an echocardiogram. After the initial 1 year study period, a 3 year post-recruitment mortality and right heart catheter check will be performed using the participants' medical records. Data will be collected from CT scans and right heart catheters if performed during the study period as part of the participants usual clinical care.
This study is designed to establish whether patients with fILD who desaturate during sleep or exercise are more likely to experience functional decline, as well as confirm previous findings of increased mortality and worsening quality of life as demonstrated in the FIBRINOX study. The data generated by this observational study will help generate future hypotheses, research questions and clinical study.
- Being tested
- Prospective
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Fibrosis, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProspectiveOther
Collection of prospective data all ready available for participant
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | All participants will be in one group which is the collection of retrospective data Receives: Other: Prospective |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute walk distance
As measured by 6-minute walk test
Measured: 52 weeks
Secondary outcomes (23)
Mortality
If death occurs during the study period, and the cause of death
Measured: 52 and 156 weeks
Clinical deterioration
Defined by: decline in forced vital capacity (FVC) >10% or death
Measured: 52 weeks
Decline in FVC
Decline in forced vital capacity
Measured: 52 weeks
Decline in TLCO
Decline in total diffusing capacity of the lungs for carbon monoxide
Measured: 52 weeks
Pulmonary hypertension
Right heart catheter confirmed pulmonary hypertension
Measured: 52 and 156 weeks
Change in arterialised capillary blood gas pO2
Arterialised capillary blood gas partial pressure of oxygen
Measured: 52 weeks
Change in arterialised capillary blood gas oxygen saturations
Arterialised capillary blood gas oxygen saturations
Measured: 52 weeks
Change in arterialised capillary blood gas pCO2
Arterialised capillary blood gas partial pressure of carbon dioxide
Measured: 52 weeks
Change in arterialised capillary blood gas HCO3
Arterialised capillary blood gas partial pressure of bicarbonate
Measured: 52 weeks
Change in arterialised capillary blood gas pH
Arterialised capillary blood gas pH
Measured: 52 weeks
Time to first acute exacerbation of fILD
The number of days until the participant requires hospital admission for an acute worsening of their respiratory condition, not attributable to other causes
Measured: 52 weeks
Rate of acute exacerbation of fILD
The number of times the participant requires hospital admission for an acute worsening of their respiratory condition, not attributable to other causes
Measured: 52 weeks
Change in NT-proBNP/BNP level
Change in NT-proBNP/BNP level from baseline
Measured: 52 weeks
Change in troponin level
Change in troponin level from baseline
Measured: 52 weeks
Change in peak TRV
Change in peak tricuspid regurgitation velocity (TRV)
Measured: 52 weeks
Change in cardiac chamber size/area
Change in cardiac chamber size/area
Measured: 52 weeks
Change in cardiac chamber area
Change in cardiac chamber area
Measured: 52 weeks
Change in RV/LV basal diameter area ratio
Change in right ventricle to left ventricle basal diameter area ratio
Measured: 52 weeks
Change in MPA:AA diameter ratio
Change in main pulmonary artery to ascending aorta diameter ratio
Measured: 52 weeks
Change in TAPSE/sPAP ratio
Change in tricuspid annular plane systolic excursion to systolic pulmonary artery pressure ratio
Measured: 52 weeks
Change in European Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) questionnaire score
Change in score of European Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) questionnaire
Measured: 52 weeks
Change in King's Brief Interstitial Lung Disease (KBILD) questionnaire score
Change in score of King's Brief Interstitial Lung Disease (KBILD) questionnaire
Measured: 52 weeks
Change in Living with Pulmonary Fibrosis (L-IPF) questionnaire score
Change in score of Living with Pulmonary Fibrosis (L-IPF) questionnaire
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex West, MBBS, Principal investigator, Guys and St. Thomas NHS Foundation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416163
- Sponsor's protocol ID
- 329843
- Acronym
- FIBRINOX-EXTRA
- Status last verified
- Jul 2024
- First submitted
- 19 Jan 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared or made available to researchers outside of the site research team where the patient is based, and GSTT ILD research team.
Publications
Myall KJ, West AG, Martinovic JL, Lam JL, Roque D, Wu Z, Maher TM, Molyneaux PL, Suh ES, Kent BD. Nocturnal Hypoxemia Associates With Symptom Progression and Mortality in Patients With Progressive Fibrotic Interstitial Lung Disease. Chest. 2023 Nov;164(5):1232-1242. doi: 10.1016/j.chest.2023.05.013. Epub 2023 May 13.
PubMed 37187434
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Investigating Whether Nocturnal Hypoxaemia and Exercise Induced Desaturation Predict Functional Deterioration in Patients With Fibrotic Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT06416163
- Acronym / sponsor ID
- FIBRINOX-EXTRA / 329843
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 16 May 2024 (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 an observational clinical research study investigating patients with fibrotic interstitial lung disease (fILD), also known as pulmonary fibrosis.
It is not known why some patients with fILD clinically deteriorate. This study will investigate whether measuring oxygen levels during sleep or exercise can help identify patients who are at increased risk of clinical deterioration.
Detailed description
This work will build upon the FIBRINOX study, previous clinical research conducted by the Guy's and St Thomas' ILD research team. The FIBRINOX study showed that patients with fILD and normal oxygen saturations at rest, but who desaturate whilst asleep or during exercise, have a significantly increased mortality and greater reduction in quality of life compared to patients who do not desaturate at night or during exercise.
The reasons for these differences in mortality and health related quality of life are not known. Data suggests that worsening fILD and the development of pulmonary hypertension, a condition characterised by increased pressure in the pulmonary arteries that is associated with poorer outcomes, may be playing a role.
This clinical research study will recruit approximately 160 patients with a tertiary ILD centre diagnosis of fibrotic interstitial lung disease (fILD). Data from routinely performed investigations as part of tertiary ILD assessment will be systematically recorded.
Investigations will include lung function tests, echocardiography, blood tests, a 6-minute walk test and overnight oximetry. Participants will also complete several quality-of-life questionnaires. These investigations will be performed at baseline, and again at 12 months, with all tests also repeated at 6 months except for an echocardiogram. After the initial 1 year study period, a 3 year post-recruitment mortality and right heart catheter check will be performed using the participants' medical records. Data will be collected from CT scans and right heart catheters if performed during the study period as part of the participants usual clinical care.
This study is designed to establish whether patients with fILD who desaturate during sleep or exercise are more likely to experience functional decline, as well as confirm previous findings of increased mortality and worsening quality of life as demonstrated in the FIBRINOX study. The data generated by this observational study will help generate future hypotheses, research questions and clinical study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Other: ProspectiveAll participants will be in one group which is the collection of retrospective data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a tertiary ILD centre diagnosis of fibrotic interstitial lung disease
Key inclusion criteria (3 listed)
- Patients aged 18 year and over
- Tertiary MDT diagnosis of FILD with >10% fibrosis on CT chest as determined by the investigator. Underlying diagnoses to include but not limited to: idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), chronic hypersensitivity pneumonitis (CHP), connective tissue disease-related interstitial lung disease (CTD-ILD), fibrotic organising pneumonia (FOP) and pulmonary sarcoidosis.
- Able to provide informed written consent
Key exclusion criteria (8 listed)
- The use of or any indication for long-term oxygen therapy (LTOT)
- Known moderate or severe obstructive sleep apnoea with an apnoea/hypopnoea index (AHI) or oxygen desaturation index (ODI) over 15 events per hour
- Radiological predominance of emphysema compared with fibrosis on CT chest
- Inability to complete all health status questionnaires as set out in this protocol, with appropriate support
- A confirmed diagnosis of pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProspectiveCollection of prospective data all ready available for participant | Other | Retrospective |
Primary outcome
Change in 6-minute walk distance
Time frame: 52 weeks
As measured by 6-minute walk test
23 secondary outcomes
Mortality
Time frame: 52 and 156 weeks
Clinical deterioration
Time frame: 52 weeks
Decline in FVC
Time frame: 52 weeks
Decline in TLCO
Time frame: 52 weeks
Pulmonary hypertension
Time frame: 52 and 156 weeks
Change in arterialised capillary blood gas pO2
Time frame: 52 weeks
Change in arterialised capillary blood gas oxygen saturations
Time frame: 52 weeks
Change in arterialised capillary blood gas pCO2
Time frame: 52 weeks
Change in arterialised capillary blood gas HCO3
Time frame: 52 weeks
Change in arterialised capillary blood gas pH
Time frame: 52 weeks
Time to first acute exacerbation of fILD
Time frame: 52 weeks
Rate of acute exacerbation of fILD
Time frame: 52 weeks
Change in NT-proBNP/BNP level
Time frame: 52 weeks
Change in troponin level
Time frame: 52 weeks
Change in peak TRV
Time frame: 52 weeks
Change in cardiac chamber size/area
Time frame: 52 weeks
Change in cardiac chamber area
Time frame: 52 weeks
Change in RV/LV basal diameter area ratio
Time frame: 52 weeks
Change in MPA:AA diameter ratio
Time frame: 52 weeks
Change in TAPSE/sPAP ratio
Time frame: 52 weeks
Change in European Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) questionnaire score
Time frame: 52 weeks
Change in King's Brief Interstitial Lung Disease (KBILD) questionnaire score
Time frame: 52 weeks
Change in Living with Pulmonary Fibrosis (L-IPF) questionnaire score
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 37187434Myall KJ, West AG, Martinovic JL, Lam JL, Roque D, Wu Z, Maher TM, Molyneaux PL, Suh ES, Kent BD. Nocturnal Hypoxemia Associates With Symptom Progression and Mortality in Patients With Progressive Fibrotic Interstitial Lung Disease. Chest. 2023 Nov;164(5):1232-1242. doi: 10.1016/j.chest.2023.05.013. Epub 2023 May 13.
- Individual participant dataSharing planned: No. No individual participant data will be shared or made available to researchers outside of the site research team where the patient is based, and GSTT ILD research team.
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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.
Alex West, MBBS principal investigator
Guys and St. Thomas NHS Foundation Hospital
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 Interstitial Lung Disease and Fibrosis Lung, run by Guy's and St Thomas' 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 8 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Lawrence, MBBS (02071887188 ext. 58207, alexandra.lawrence@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-minute walk distance (time frame: 52 weeks). 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 NCT06416163, which also lists 1 linked publication.
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 Jul 2024.