Clinical Trial

Interstitial Lung Disease Exacerbations Study

Study acronym: INDEX
Active, Not Recruiting
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Record status
This record was last updated May 18, 2025 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-11.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-05-14
Trial Details
NCT Number NCT06685874
Lead Sponsor Royal Devon and Exeter NHS Foundation Trust
Collaborators: University Hospitals, Leicester, Nottingham University Hospitals NHS Trust, North Bristol NHS Trust, Papworth Hospital NHS Foundation Trust
Conditions Interstitial Lung Disease (ILD), Pulmonary Fibrosis
Enrollment 1,500 participants
Start Date 2025-05-01
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-18