It's Not JUST Idiopathic Pulmonary Fibrosis Study

Idiopathic Pulmonary Fibrosis Clinical Trial

— INJUSTIS  

Official title:

It's Not JUST Idiopathic Pulmonary Fibrosis Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03670576
• Other study ID #: 18014
• Status: Recruiting
• Start date: November 11, 2018
• Est. completion date: November 11, 2022

Study information

• Verified date: July 2021
• Source: University of Nottingham
• Contact: Prof Gisli Jenkins
• Phone: 0115 8231711
• Email: gisli.jenkins[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study of progression of fibrosis in ILD

Description:

The overall aims of this study are

• Identify biomarkers and gene expression profiles that determine progressive fibrotic lung disease regardless of aetiology

• To prospectively assess biomarkers which predict progressive fibrosis in patients with fibrosing lung disease of alternate aetiology, including RA-UIP, Asbestosis, Chronic Hypersensitivity Pneumonitis and Unclassifiable fibrotic lung disease

• Investigate genetic associations and epigenetic modifications which affect fibrotic disease severity and progression

• Prospectively evaluate longitudinal disease behaviour in patients with non IPF-fibrotic lung diseases with a view to developing composite clinical end-points for subsequent use in intervention studies in patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 11, 2022
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Male or female aged = 18 years old

• Able and willing to give written informed consent

• Recently diagnosed [defined as diagnostic CT scan or surgical lung biopsy (if applicable) >1st May 2017]

• An MDT diagnosis of fibrotic interstitial lung disease (reticulation, traction +/- honeycombing)

Sub Groups

• Rheumatoid arthritis (rheumatologist diagnosed with anti-CCP antibodies and/or Rheumatoid Factor positive)

• Asbestosis (appropriate occupational history and radiological evidence of asbestos exposure)

• Chronic HP in accordance with consensus criteria (appropriate exposure history, radiological features +/- avian and fungal precipitins)

• Unclassifiable fibrotic lung disease (fibrotic lung disease otherwise unclassifiable despite extensive clinical and radiological examination)

• IPF in accordance with consensus criteria (ATS/ERS/JRS/ALAT guidelines) as controls

Exclusion Criteria:

• Participating in an interventional clinic trial

• Asymptomatic Interstitial Lung Abnormalities (ILA) and normal lung function.

• Change in clinical phenotype from initial radiological diagnosis to screening

• Acute Hypersensitivity Pneumonitis.

• Participants who do not possess a smartphone or have a valid email address (necessary for the home FVC readings)

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Intervention

Procedure:
• Optional Bronchoscopy
Patients can decide to have an optional bronchoscopy so that samples can be taken for research up to three months from baseline.

Other:
• Quality of Life Questionnaires
MRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months,
• Blood Samples for Biomarkers
a 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months.
• Home Hand Held Spirometry
Patients will download an app and are given a small hand held device to record their own spirometry at home. This is blinded for the first three months of the study and then requested a week before and a week after the three follow up points (3m, 12m, 24m)

Locations

Country	Name	City	State
United Kingdom	Royal United Hospitals Bath NHS Trust	Bath
United Kingdom	University Hospitals Birmingham	Birmingham
United Kingdom	Blackpool Victoria Hospital	Blackpool
United Kingdom	Southmead Hospital North Bristol	Bristol
United Kingdom	Queens Hospital Burton	Burton on Trent	Derbyshire
United Kingdom	University Hospitals Coventry and Warwickshire	Coventry
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	Royal Devon and Exeter Hospital	Exeter
United Kingdom	Medway Maritime Hospital	Gillingham
United Kingdom	Kingston Hospital NHS Foundation Trust	London
United Kingdom	St Georges Hospital	London
United Kingdom	North Manchester General Hospital	Manchester
United Kingdom	Wythenshawe Hospital	Manchester
United Kingdom	Kings Mill Hospital	Mansfield	Nottingham
United Kingdom	Newcastle Upon Tyne NHS Foundation Trust	Newcastle
United Kingdom	Northumbria Healthcare NHS Foundation Trust	Newcastle
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	South Tyneside District Hospital	South Shields
United Kingdom	University Hospital of North Tees	Stockton-on-Tees
United Kingdom	Taunton and Somerset NHS Foundation Trust	Taunton
United Kingdom	Royal Albert and Edward Infirmary	Wigan
United Kingdom	New Cross Hospital	Wolverhampton
United Kingdom	Worcestershire Royal Hospital	Worcester

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	DLco	Diffusing Capacity of the Lung for Carbon Monoxide	Baseline, 3 months, 12 months, 24 months
Other	Quality of Life Questionnaires	Assessment of how the patients well-being may be affected over time by their interstitial lung disease	Baseline, 3 months, 12 months, 24 months.
Other	Domicillary Spirometry	Change in home handheld spirometry values from baseline to 12 weeks	Daily for the first 3 months of study then at 2 week periods around time of planned follow up
Primary	Disease Progression	Disease progression defined as >10% relative decline in FVC (using either hospital spirometry or home hand held spirometry) or death within 12 months.	Within 12 months
Primary	Overall Survival	All patients will be tagged at the central NHS registry in order to provide mortality data. For this reason we will need to keep our datasets active for up to 10 years to allow a complete mortality analysis.	10 years
Secondary	Serum and Plasma Biomarkers	SPD, MUC16, CA199, Nordic Neoepitopes	Baseline, 3 months, 12 months, 24 months