FIBRotic Interstitial Lung Disease With Nocturnal hypOXaemia and EXercise Induced desaTuRAtion

NCT06416163 | Not Yet Recruiting

• 1 other identifier: 329843
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. This study will investigate whether measuring oxygen levels during sleep or exercise can help identify patients who are at increased risk of clinical deterioration.

Conditions

Interstitial Lung Disease; Fibrosis Lung; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute walk distance

  As measured by 6-minute walk test

  52 weeks

Secondary Outcomes (23)

• Mortality

  52 and 156 weeks

• Clinical deterioration

  52 weeks

• Decline in FVC

  52 weeks

• Decline in TLCO

  52 weeks

• Pulmonary hypertension

  52 and 156 weeks

Study Arms (1)

Retrospective

All participants will be in one group which is the collection of retrospective data

Other: Prospective

Interventions

Prospective OTHER

Collection of prospective data all ready available for participant

Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a tertiary ILD centre diagnosis of fibrotic interstitial lung disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37187434 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Fibrosis; Hypertension, Pulmonary

Interventions

Longitudinal Studies

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alex West, MBBS

  Guys and St. Thomas NHS Foundation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Lawrence, MBBS

CONTACT

02071887188; alexandra.lawrence@gstt.nhs.uk

Gillian Radcliffe, BSc

CONTACT

07395285492; gillian.radcliffe@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: May 16, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)