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

Organizational Data

DRKS-ID:
DRKS00027389
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2021-12-07
Last update in DRKS:
2024-03-25
Registration type:
Prospective

Acronym/abbreviation of the study

INSIGHTS-ILD Registry

URL of the study

http://www.insights-ild.de

Brief summary in lay language

The new INSIGHTS-ILD registry is designed as a "sister" registry of INSIGHTS-IPF. Its objective is to comprehensively document patients with progressive fibrosing interstitial pulmonary fibrosis (PF-ILD) with regard to various aspects of the disease (patient characteristics, diagnostics, type/efficacy/tolerability of therapy, outcomes). The start of the study coincides with a phase in which new treatment options are available for PF-ILD. We hypothesize that PF-ILD represents a broad clinical phenotype differentially influenced by inflammatory and fibrotic pathomechanisms that need to be treated individually with anti-inflammatory and/or anti-fibrotic treatment strategies.

Brief summary in scientific language

To provide comprehensive information on different PF-ILD within routine clinical practice: utilization of medication, efficacy, safety, quality of life and other patient related outcomes (PRO), and economic variables, including post-treatment follow-up.

Health condition or problem studied

ICD10:
J84.1 - Other interstitial pulmonary diseases with fibrosis
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Patients with progressive fibrosing interstitial pulmonary fibrosis (PF-ILD) are followed for several years: the diagnosis, the disease itself (e.g., symptoms, diagnosis date), the use of medications (especially antifibrotic), their efficacy, safety, quality of life, and other patient-reported outcomes (PROs), and economic variables.Data are taken from the medical record, and no data are documented outside of the clinical routine.

Endpoints

Primary outcome:
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 outcome:
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

Study Design

Purpose:
Prognosis
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Longitudinal study
Study type non-interventional:
Epidemiological study

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center LMU Medizinische Klinik V Müchen
  • Medical center Medizinische Hochschule Hanover
  • Medical center Asklepios Fachkliniken Gauting
  • Medical center Vivantes Neukölln
  • Medical center Thoraxklinik Heidelberg
  • Medical center Universiätsklinik Bonn
  • Medical center CIMS Bamberg
  • Medical center Städtisches Krankenhaus München-Bogenhausen
  • Medical center Schillerhöhe Gerlingen
  • Medical center Fachkrankenhaus Coswig Coswig
  • Medical center Klinikum Bethanien Solingen

Recruitment period and number of participants

Planned study start date:
2021-12-20
Actual study start date:
2021-12-09
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
900
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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

Addresses

Primary Sponsor

GWT-TUD GmbH Innovationszentrum Real World Evidence
Prof. Dr. med. David Pittrow
Freiberger Str. 33
01067 Dresden
Germany
Telephone:
0351 25933186
Fax:
No Entry
Contact per E-Mail
URL:
http://www.g-wt.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Ludwig-Maximilian-Universität, Med. Klinik V
Prof. Dr. med. habil. Jürgen Behr
Marcchioninistr. 15
81377 München
Germany
Telephone:
+49 89 440075310
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

GWT-TUD GmbH Innovationszentrum Real World Evidence
Prof. Dr. med. David Pittrow
Freiberger Str. 33
01067 Dresden
Germany
Telephone:
0351 25933186
Fax:
No Entry
Contact per E-Mail
URL:
http://www.g-wt.de

Principal Investigator

Ludwig-Maximilian-Universität, Med. Klinik V
Prof. Dr. med. habil. Jürgen Behr
Marcchioninistr. 15
81377 München
Germany
Telephone:
+49 89 440075310
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Boehringer Ingelheim Pharma GmbH & Co. KGHP Country Medical Affairs
Binger Straße 173
55216 Ingelheim
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://www.boehringer-ingelheim.de/unser-unternehmen/gesellschaften-in-deutschland

Ethics Committee

Address Ethics Committee

Sächsische Landesärztekammer Ethikkommission
Schützenhöhe 16
01099 Dresden
Germany
Telephone:
+49-351-8267333
Fax:
+40-351-8267332
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-10-21
Ethics committee number:
EK-BR-125/21-1
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-12-02

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
Publikation der Methoden (=Zusammenfassung des Protokolls): Behr et al. BMC Pulm Med. 2023 Feb 11;23(1):64. doi: 10.1186/s12890-023-02333-7.
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry