FIBRotic Interstitial Lung Disease With Nocturnal hypOXaemia and EXercise Induced desaTuRAtion
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuy's and St Thomas' NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with a tertiary ILD centre diagnosis of fibrotic interstitial lung disease
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Prospective
Other interventionCollection of prospective data all ready available for participant
Treatment groups
160 Participants
are divided into 1 treatment groupGroup A: Retrospective1 intervention
Trial outcomes
Primary outcomes
1
Change in 6-minute walk distance
As measured by 6-minute walk test
Time frame
52 weeksSecondary outcomes
1
Mortality
If death occurs during the study period, and the cause of death
Time frame
52 and 156 weeks2
Clinical deterioration
Defined by: decline in forced vital capacity (FVC) \>10% or death
Time frame
52 weeks3
Decline in FVC
Decline in forced vital capacity
Time frame
52 weeks4
Decline in TLCO
Decline in total diffusing capacity of the lungs for carbon monoxide
Time frame
52 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: