INvestigating SIGnificant Health TrendS in Management of Progressive Fibrosing Interstitial Lung Disease (INSIGHTS-ILD)

INvestigating SIGnificant Health TrendS in Management of Progressive Fibrosing Interstitial Lung Disease (INSIGHTS-ILD) - INSIGHTS-ILD Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027389

Enrollment

1900

Registered

2021-12-07

Start date

2021-12-09

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J84.1

Interventions

Group 1: Study Phase 1.0 (Enrollment until April 2025): Patients with progressive fibrosing interstitial pulmonary fibrosis (PF-ILD) are followed for several years: the diagnosis, the disease itself (

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Phase 1.0 • PF-ILDs, which include all ILD groups including those with IIPs, CTD-ILD, chronic hypersensitivity pneumonitis, asbestosis, sarcoidosis, etc. • Age = 18 years • Interstitial lung disease on HRCT > 10 % of lung parenchyma • DLco = 80 % predicted • On active anti-inflammatory, immunomodulatory, and or anti-fibrotic therapy • Written informed consent Phase 2.0 • Patients with progressive fibrosing interstitial lung diseases (PF-ILD) according to INBUILD/FIBRONEER criteria: all ILD groups, including those with IIPs, CTD-ILD, chronic hypersensitivity pneumonitis, asbestosis, sarcoidosis, etc., • or IPF (per ATS/ERS/JRS/ALAT guidelines 2022). • Age = 18 years • Written informed consent after counseling

Exclusion criteria

Exclusion criteria: • Diagnosis of IPF (only in Phase 1.0) • Concomitant participation in a controlled ILD-related clinical trial, if blinded and/or with investigational drugs

Design outcomes

Primary

Measure	Time frame
Time to progression of disease (any one of the following): • Decrease of FVC > 10 % predicted within one year; • decrease in DLco > 15 % predicted plus initiation of LTOT or permanent increase of oxygen flow when LTOT is established within one year; • decrease of 6-MWD > 50 m within one year; • hospitalization due to respiratory decompensation, • death of any cause; • change of treatment strategy (stop of anti-inflammatory or antifibrotic therapy, initiation of new anti-inflammatory or antifibrotic therapy or a combination of both).	—

Measure

Time frame

Time to progression of disease (any one of the following): • Decrease of FVC > 10 % predicted within one year; • decrease in DLco > 15 % predicted plus initiation of LTOT or permanent increase of oxygen flow when LTOT is established within one year; • decrease of 6-MWD > 50 m within one year; • hospitalization due to respiratory decompensation, • death of any cause; • change of treatment strategy (stop of anti-inflammatory or antifibrotic therapy, initiation of new anti-inflammatory or antifibrotic therapy or a combination of both).

—

Secondary

Measure	Time frame
Drug utilization • Treatment strategy (immunosuppression, antifibrotic therapy) • dose and dosing schedule • duration of treatment (persistence) • switches between treatments • phases without drug treatment (with reasons) • reasons for drug discontinuation Effectiveness: risk factors for progression of disease, factors for treatment success or failure, respectively • Survival • Clinical symptoms • dyspnea • cough • Lung function • Annual DLCO decline • Annual FVC decline • 6-min walk distance • QoL scores over time • Radiographic course: fibrosis on HRCT • Therapy escalation • Clinical events (exacerbations, hospitalisations) Biomarkers to differentiate inflammatory driven from fibrosis driven progress • CRP • LDH • differential blood cell count (lymphocytes, neutrophils, eosinophils, monocytes), • BAL differential cell count (as available). Safety • Adverse Events	—

Measure

Time frame

Drug utilization • Treatment strategy (immunosuppression, antifibrotic therapy) • dose and dosing schedule • duration of treatment (persistence) • switches between treatments • phases without drug treatment (with reasons) • reasons for drug discontinuation Effectiveness: risk factors for progression of disease, factors for treatment success or failure, respectively • Survival • Clinical symptoms • dyspnea • cough • Lung function • Annual DLCO decline • Annual FVC decline • 6-min walk distance • QoL scores over time • Radiographic course: fibrosis on HRCT • Therapy escalation • Clinical events (exacerbations, hospitalisations) Biomarkers to differentiate inflammatory driven from fibrosis driven progress • CRP • LDH • differential blood cell count (lymphocytes, neutrophils, eosinophils, monocytes), • BAL differential cell count (as available). Safety • Adverse Events

—

Countries

Germany

Contacts

Public ContactDavid Pittrow

GWT-TUD GmbH Innovationszentrum Real World Evidence

david.pittrow@g-wt.de0351 25933186

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026