An observational study in Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, sponsored by University of Nottingham. Status unknown at 24 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-02.
Sponsored by University of Nottingham · Observational
Study of progression of fibrosis in ILD
The overall aims of this study are
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 250 is above the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →University of Nottingham is the lead sponsor of 456 studies on the registry; 78 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited from ILD and IPF clinics.
Sub Groups
Exclusion Criteria:
A diagnosis of Fibrotic Lung disease classified in 4 categories, RA-UIP, Asbestosis, Chronic HP and Unclassifiable as agreed by an ILD MDT consensus panel.
Procedure: Optional Bronchoscopy · Other: Quality of Life Questionnaires · Other: Blood Samples for Biomarkers · Other: Home Hand Held Spirometry
Positive control will be frequency matched to cases of ILD and will be people in secondary care who have an MDT diagnosis of Definite IPF.
Procedure: Optional Bronchoscopy · Other: Quality of Life Questionnaires · Other: Blood Samples for Biomarkers · Other: Home Hand Held Spirometry
Patients can decide to have an optional bronchoscopy so that samples can be taken for research up to three months from baseline.
MRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months,
a 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months.
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)
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.
Time frame: Within 12 months
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.
Time frame: 10 years
Serum and Plasma Biomarkers
SPD, MUC16, CA199, Nordic Neoepitopes
Time frame: Baseline, 3 months, 12 months, 24 months
DLco
Diffusing Capacity of the Lung for Carbon Monoxide
Time frame: Baseline, 3 months, 12 months, 24 months
Quality of Life Questionnaires
Assessment of how the patients well-being may be affected over time by their interstitial lung disease
Time frame: Baseline, 3 months, 12 months, 24 months.
Domicillary Spirometry
Change in home handheld spirometry values from baseline to 12 weeks
Time frame: Daily for the first 3 months of study then at 2 week periods around time of planned follow up
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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University of Nottingham