INvestigating SIGnificant Health TrendS in Management of Progressive Fibrosing Interstitial Lung Disease (INSIGHTS-ILD)
Recruiting
- Conditions
- J84.1Other interstitial pulmonary diseases with fibrosis
- Registration Number
- DRKS00027389
- Lead Sponsor
- GWT-TUD GmbH Innovationszentrum Real World Evidence
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 900
Inclusion Criteria
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
Exclusion Criteria
• Diagnosis of IPF
• Concomitant participation in a controlled ILD-related clinical trial, if blinded and/or with investigational drugs
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to progression of disease (any one of the following): <br>• Decrease of FVC > 10 % predicted within one year; <br>• decrease in DLco > 15 % predicted plus initiation of LTOT or permanent increase of oxygen flow when LTOT is established within one year; <br>• decrease of 6-MWD > 50 m within one year; <br>• hospitalization due to respiratory decompensation, <br>• death of any cause; <br>• 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 Outcome Measures
Name Time Method Drug utilization<br>• Treatment strategy (immunosuppression, antifibrotic therapy)<br>• dose and dosing schedule<br>• duration of treatment (persistence)<br>• switches between treatments<br>• phases without drug treatment (with reasons)<br>• reasons for drug discontinuation <br>Effectiveness: risk factors for progression of disease, factors for treatment success or failure, respectively<br>• Survival <br>• Clinical symptoms<br>• dyspnea <br>• cough<br>• Lung function<br>• Annual DLCO decline<br>• Annual FVC decline<br>• 6-min walk distance <br>• QoL scores over time<br>• Radiographic course: fibrosis on HRCT<br>• Therapy escalation<br>• Clinical events (exacerbations, hospitalisations)<br>Biomarkers to differentiate inflammatory driven from fibrosis driven progress <br>• CRP <br>• LDH<br>• differential blood cell count (lymphocytes, neutrophils, eosinophils, monocytes), <br>• BAL differential cell count (as available).<br>Safety<br>• Adverse Events