Interstitial Lung Disease Exacerbations Study

NCT06685874 | Active Not Recruiting

• 1 other identifier: 2501703
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 3

Brief Summary

Interstitial lung disease (ILD) is an umbrella term covering numerous conditions that affect the lung tissue, interfering with the ability of the lungs to take up oxygen. Most ILDs get worse gradually, but sometimes patients can experience a sudden worsening in their symptoms called an acute exacerbation (AE-ILD). Most studies in this area have been done in AEs of idiopathic pulmonary fibrosis (AE-IPF), as IPF is the commonest form of ILD. AE-IPF has very poor outcomes, however AEs of other ILDs are less well studied. Furthermore, there is currently no treatment guideline or established standard of care for the management of patients with AE-fILD. The aim of this research project is to gain a better understanding of AE-ILD in a real-world population. By looking at the clinical records of patients with AE-ILD, the study aims to describe the patient population that gets AE-ILD and how these patients are treated in the "real world" setting. The study will also gather information on patient characteristics such as type of ILD and test results at the time of AE-ILD, and see if any of these factors are associated with better/ worse outcomes in AE-ILD. Finally, the study will collect data on the treatment approaches taken, including both medical therapy such as steroid treatment, as well as specialist care team input. This data on treatment will be used to identify associations between individual treatments and outcomes, as well as to evaluate the NHS services being provided to patients with AE-ILD. Overall, this study will enhance understanding of AE-ILD. This study will provide information to help design clinical trials to test treatments for AE-ILD, to help us create evidence-based clinical guidelines for AE-ILD, and improve the management of patients with AE-ILD.

Conditions

Interstitial Lung Disease (ILD); Pulmonary Fibrosis

Keywords

Interstitial lung disease; Exacerbation

Outcome Measures

Primary Outcomes (1)

• Transplant free survival

  Transplant-free survival

  90 days post date of hospital admission

Secondary Outcomes (4)

• Transplant free survival

  Date of discharge from hospital for index admission (Up to 24 hours), 30 days, 90 days (Primary endpoint), 6 months, 1 year

• Pulmonary Function Testing

  6 months and 12 months from date of index admission

• Pulmonary function testing

  6 months and 12 months from date of index admission

• Oxygen

  At the point of discharge from index admission (up to 24 hours)

Study Arms (1)

Patients with exacerbation of fibrotic interstitial lung disease

Patients with exacerbation of fibrotic interstitial lung disease as per inclusion and exclusion criteria

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 fibrotic interstitial lung disease admitted to hospital with exacerbation of pulmonary fibrosis as per inclusion and exclusion criteria

You may qualify if:

• Patients admitted to an acute NHS trust during study period 1st September 2022-31st August 2023 with an underlying or new diagnosis of an ILD (defined by ICD-10 codes in Table 1) with a fibrotic phenotype (established fibrosis on current or previous radiological imaging) AND
• Increasing pulmonary symptoms AND
• No extra-parenchymal cause identified as primary cause of admission
• Segmental or larger pulmonary embolus as main discharge diagnosis in absence of acute exacerbation features on imaging
• Pleural effusion as main discharge diagnosis
• Pneumothorax as main discharge diagnosis in absence of acute exacerbation features on imaging
• Left sided heart failure or volume overload

You may not qualify if:

• No underlying or new diagnosis of ILD with a fibrotic phenotype
• Acute presentation of pneumonitis/ILD without evidence of fibrosis (Table 2)
• Non-respiratory related hospital admission (no increasing pulmonary symptoms)
• Respiratory related hospital admission due to extra-parenchymal cause
• Segmental or larger pulmonary embolus as main discharge diagnosis in absence of acute exacerbation features on imaging
• Pleural effusion as main discharge diagnosis
• Pneumothorax as main discharge diagnosis in absence of acute exacerbation features on imaging
• Left sided heart failure or volume overload
• Participant signatory to NHS National Data Opt Out
• Elective/non-emergency admission
• Admission under non-medical specialty
• In cases where there are \>=1 eligible admissions only the first (index) admission shall be included

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• University Hospitals, Leicester: collaborator
• Nottingham University Hospitals NHS Trust: collaborator
• North Bristol NHS Trust: collaborator
• Papworth Hospital NHS Foundation Trust: collaborator

Study Sites (3)

Royal United Hospitals Bath NHS Foundation Trust

Bath, United Kingdom

Location

North Bristol NHS Trust

Bristol, United Kingdom

Location

Royal Devon University Hospitals NHS Foundation Trust

Exeter, United Kingdom

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Gibbons, MBChB

  Royal Devon and University healthcare trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 13, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)