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INDEX
Sponsor study identifier
observational
1,500
1 country
3
Study Start
May 1, 2025
Actual (reported)Primary Completion
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2024
Actual (reported)November 13, 2024
Actual (reported)May 1, 2025
Actual (reported)August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Transplant free survival
Transplant-free survival
90 days post date of hospital admission
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)
Patients with exacerbation of fibrotic interstitial lung disease as per inclusion and exclusion criteria
Patients with fibrotic interstitial lung disease admitted to hospital with exacerbation of pulmonary fibrosis as per inclusion and exclusion criteria
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
Royal Devon University Hospitals NHS Foundation Trust
Exeter, United Kingdom
Goodwin AT, Dixon G, White LJ, Virk H, Nadeem I, Saini G, Khan F, Parfrey H, Scotton CJ, Barratt SL, Taylor G, Gibbons M. Protocol for the INterstitial lung Disease EXacerbations (INDEX) Study: a retrospective multicentre cohort study. BMJ Open Respir Res. 2026 Jun 9;13(1):e003949. doi: 10.1136/bmjresp-2025-003949.
Michael Gibbons, MBChB
Royal Devon and University healthcare trust
First Submitted
October 30, 2024
First Posted
November 13, 2024
Study Start
May 1, 2025
Actual (reported)Primary Completion
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
August 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 18, 2025
Record last verified: 2025-04
IPD will not be shared due to lack of informed consent.
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Source: ClinicalTrials.gov.
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