Trials
Search / Trial NCT06416163

FIBRotic Interstitial Lung Disease With Nocturnal hypOXaemia and EXercise Induced desaTuRAtion

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · May 14, 2024

Trial Information

Current as of February 19, 2025

Not yet recruiting

Keywords

ClinConnect Summary

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 hypert...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients aged 18 year and over
  • 2. 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.
  • 3. Able to provide informed written consent
  • Exclusion Criteria:
  • 1. The use of or any indication for long-term oxygen therapy (LTOT)
  • 2. Known moderate or severe obstructive sleep apnoea with an apnoea/hypopnoea index (AHI) or oxygen desaturation index (ODI) over 15 events per hour
  • 3. Radiological predominance of emphysema compared with fibrosis on CT chest
  • 4. Inability to complete all health status questionnaires as set out in this protocol, with appropriate support
  • 5. A confirmed diagnosis of pulmonary hypertension
  • 6. 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
  • 7. Musculoskeletal comorbidity that will preclude the participant's ability to reliably complete the complete 6-minute walk test (6MWT)
  • 8. Participation in another research project which may confound this study's research findings

Trial Officials

Alex West, MBBS

Principal Investigator

Guys and St. Thomas NHS Foundation Hospital

About Guy's And St Thomas' Nhs Foundation Trust

Guy's and St Thomas' NHS Foundation Trust is a leading healthcare organization in the United Kingdom, renowned for its commitment to delivering high-quality patient care, innovative research, and clinical excellence. As a prominent academic health science center, the Trust integrates cutting-edge research with clinical practice, facilitating the translation of scientific discoveries into improved treatment options. With a diverse portfolio of clinical trials across various medical specialties, Guy's and St Thomas' NHS Foundation Trust plays a pivotal role in advancing healthcare knowledge and enhancing patient outcomes, while maintaining the highest ethical standards in research and patient safety.

Locations

London, , United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0