Interstitial Lung Disease Registry Study: Prospective and... | NCT06522334

Studies
Interstitial Lung Disease Registry Study: Prospective and Retrospective Observational Study in Austria

NCT06522334

Sponsor

Ludwig Boltzmann Institute for Lung Health

Status

Recruiting

Last Update Posted

Mar 14, 2025Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Interstitial Lung Disease

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2024Actual

Primary Completion Date

Feb 28, 2034Estimated

Completion Date

Feb 28, 2034Estimated

First Submitted Date

Jul 22, 2024

First Submission Date that Met QC Criteria

Jul 22, 2024

First Posted Date

Jul 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2025

Last Update Posted Date

Mar 14, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robab Breyer-Kohansal, Head of Department for Internal Medicine and Pneumology Clinic Hietzing, Ludwig Boltzmann Institute for Lung HealthPrincipal Investigator

Lead Sponsor

Ludwig Boltzmann Institute for Lung HealthOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this registry is to systematically record epidemiological and clinical data throughout the whole interstitial lung disease course - starting with the diagnosis, therapy, follow up of lung function, symptom control, adverse events, medication, survival and death.

There are no additional interventions regarding this registry.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Mortality caused by interstitial lung disease	10 years
Loss of lung function	FVC and DLCO loss within 24 months	2 years

Secondary Outcomes

Measure	Description	Time Frame
Prevalence	Prevalence of the different interstitial lung diseases in Austria	10 years
Response to drugs	Response to immunosuppressive/immunomodulating/antifibrotic drugs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of interstitial lung disease
written informed consent

Exclusion Criteria:

to not comprehend and rightfully judge participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Everybody with a diagnosis of interstitial lung disease, over 18 years old will be asked to participate.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik Hietzing	Recruiting	Vienna		1130	Austria

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided