Investigating Significant Health Trends in Idiopathic Pul... | NCT01695408

Studies
Investigating Significant Health Trends in Idiopathic Pulmonary Fibrosis

NCT01695408

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Jul 27, 2022Actual

Enrollment

1,232Actual

Phase

Not provided

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Not provided

Countries

Germany

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

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Sep 26, 2012

First Submission Date that Met QC Criteria

Sep 27, 2012

First Posted Date

Sep 28, 2012Estimated

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

Jul 25, 2022

Last Update Posted Date

Jul 27, 2022Actual

Name	Class
GWT-TUD GmbH	OTHER
Boehringer Ingelheim	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Idiopathic pulmonary fibrosis (IPF), a manifestation of chronic progressive fibrosing interstitial pneumonia,ia a rare disease. Current treatment options are limited, and the mean survival time of the newly diagnosed (mostly elderly) patients is only about 2-3 years. As in Europe data are limited on the characteristics and management of such patients, INSIGHTS-IPF was initiated as a new registry that documents newly diagnosed (incident) and prevalent patients with confirmed IPF diagnosis prospectively.The registry will contribute to the optimization of the management of IPF patients in the long term.

Detailed Description

INSIGHTS-IPF will report current and comprehensive data on Idiopathic Pulmonary Fibrosis (IPF) in the long-term.

Baseline (cross-sectional part): Description of characteristics of IPF patients in terms of

key (socio-) demographic data
IPF risk factors, comorbidities
methods used for IPF diagnosis
IPF disease severity and manifestation (including lung function, cardiopulmonary exercise testing and/or exercise capacity if available, laboratory values, biomarkers)
IPF treatment (detailed information on prescribed drugs and doses; non-pharmacological treatment; listing and score for lung transplantation)
assessment of patient-related outcomes (PRO) such as quality of life

Follow-up (prospectively up to at least 2 years after inclusion):

Clinical course of IPF (e.g. in terms of symptoms, lung function, exercise capacity if available)
Documentation of treatment pathways (switch/add-on/discontinuation of medication), and of non-pharmacological treatment (e.g. start of long term oxygen therapy; new listing for lung transplantation)Outcomes/events (such as acute respiratory worsening, exacerbations, hospitalisation due to any cause and due to IPF, other complications, survival)
Patient-related outcomes such as quality of life, assessed once a year(for comparison with baseline)
Resource use for pharmacoeconomic analyses.

Conditions Module

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Drug Treatment
Treatment pathways
Clinical routine
Registry
Outcomes
Survival
Patient-related outcomes
Quality of life
Steroids
Azathioprine
N-Acetylcysteine
Pirfenidone
Tyrosine kinase inhibitors
Nintedanib
multicenter
Germany
Safety
Adverse event

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,232Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical course of IPF (in terms of symptoms, lung function, survival)		up to 5 years after inclusion

Secondary Outcomes

Measure	Description	Time Frame
Characteristics of patients with IPF		up to 5 years after inclusion
Treatment pathways		up to 5 years after inclusion
Functionality and quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 18 years of age
Written informed consent for participation in the registry
Newly diagnosed (incident) or known (prevalent) IPF (based on diagnosis of treating physician)

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Idiopathic Pulmonary Fibrosis (confirmed diagnosis according to current ATS/ERS guidelines)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juergen Behr, MD, PhD	Ludwig-Maximilian University (LMU) Munich, Med. Clinic V	Principal Investigator
David Pittrow, MD, PhD	Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Clinical Pharmacology, Medical Faculty, Technical University		Dresden		01307	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23188642	Background	Behr J, Hoeper MM, Kreuter M, Klotsche J, Wirtz H, Pittrow D. [Characteristics and management of idiopathic pulmonary fibrosis: INSIGHTS-IPF registry]. Dtsch Med Wochenschr. 2012 Dec;137(49):2586-8. doi: 10.1055/s-0032-1327244. Epub 2012 Nov 27. German.
25478169	Background	Behr J, Hoeper MM, Kreuter M, Klotsche J, Wirtz H, Pittrow D. Investigating significant health trends in idiopathic pulmonary fibrosis (INSIGHTS-IPF): rationale, aims and design of a nationwide prospective registry. BMJ Open Respir Res. 2014 Jan 3;1(1):e000010. doi: 10.1136/bmjresp-2013-000010. eCollection 2014.

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases