The PROspective German NOn-CF bronchiectaSIS Patient Registry

Bronchiectasis Clinical Trial

— PROGNOSIS  

Official title:

The PROspective German NOn-CF bronchiectaSIS Patient Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02574143
• Other study ID #: PROGNOSIS
• Status: Recruiting
• Start date: July 2015
• Est. completion date: July 2021

Study information

• Verified date: October 2020
• Source: Hannover Medical School
• Contact: Grit Barten
• Phone: +49 511 5324434
• Email: prognosis[@]capnetz.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to study the epidemiology of non-CF bronchiectasis (NCFB) and to provide an estimate of the distribution (prevalence) of NCFB etiologies across all different levels of health care as well as real-life data regarding the current management of NCFB in Germany.

Description:

• To study the epidemiology of non-CF bronchiectasis (NCFB) and to provide an estimate of the distribution (prevalence) of NCFB etiologies across all different levels of health care as well as real-life data regarding the current management of NCFB in Germany

• To establish feasible investigational strategies in order to establish the etiology of NCFB

• To perform observational research into bronchiectasis, particularly in areas where single center datasets are underpowered, such as in rare etiologies or determining markers of prognosis

• To promote collaborative clinical, basic and translational research in NCFB between German (and European) centers

• To provide a registry of well phenotyped patients with NCFB in clinical centers potentially eligible for enrolment into clinical trials

• To track access to healthcare and cost of caring for patients with NCFB over time

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: July 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A clinical history consistent with bronchiectasis

• (High resolution) computed tomography (CT) scan of the chest demonstrating bronchiectasis affecting 1 or more lobes

Exclusion Criteria:

• Bronchiectasis due to known cystic fibrosis (CF)

• Age <18 years

• Interstitial lung disease

• Prior lung or heart-lung transplantation

Related Conditions & MeSH terms

• Bronchiectasis

Locations

Country	Name	City	State
Germany	Helios Klinikum Emil von Behring - Lungenklinik Heckeshorn	Berlin
Germany	Augusta-Kranken-Anstalt Bochum -Klinik für Pneumologie, Beatmungsmedizin und Infektiologie	Bochum
Germany	Fachkrankenhaus Coswig	Coswig
Germany	Klinik Donaustauf - Zentrum für Pneumologie	Donaustauf
Germany	Klinikum Dortmund Medizinische Klinik Nord - Pneumologie, Infektiologie und Internistische Intensivmedizin	Dortmund
Germany	Universitätsklinikum Carl Gustav Carus an der TU Dresden Medizinische Klinik und Poliklinik I, Bereich Pulmologie	Dresden
Germany	Florence-Nightingale-Krankenhaus Klinik für Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin	Düsseldorf
Germany	Praxis am Maingau Krankenhaus Gemeinschaftspraxis für Innere Medizin, Lungen- und Bronchialheilkunde, Allergologie	Frankfurt
Germany	Universitätsklinikum Freiburg Abteilung für Klinische Infektiologie	Freiburg
Germany	UKGM - Standort Gießen Medizinische Klinik und Poliklinik II	Giessen
Germany	LungenClinic Großhansdorf	Großhansdorf
Germany	Medizinische Hochschule Hannover-Klinik für Pneumologie	Hannover
Germany	Universitätsklinikum Heidelberg und Thoraxklinik Heidelberg	Heidelberg
Germany	Universitätsklinikum Jena Zentrum für Infektionsmedizin und Krankenhaushygiene	Jena
Germany	Universitätsklinikum Schleswig-Holstein Medizinische Klinik III - Pneumologie / Infektiologie	Lübeck
Germany	Klinikum Lüdenscheid Klinik für Pneumologie, Infektiologie, Schlafmedizin und Internistische Intensivmedizin	Lüdenscheid
Germany	Klinikum der Philipps-University Marburg	Marburg
Germany	Klinikum der Ludwig-Maximilians-Universität München	München
Germany	Diakoniekrankenhaus Rotenburg Zentrum für Pneumologie	Rotenburg

Sponsors (3)

Lead Sponsor	Collaborator
Hannover Medical School	CAPNETZ Stiftung, German Center for Lung Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with non-CF bronchiectasis (NCFB) across all different levels of health care regarding the current management of NCFB in Germany	To establish a national, representative, prospective, observational and longitudinal NCFB database and collaborative research network with a database including a minimum of 750 patients from a minimum of 25 centers from all levels of healthcare across Germany after a period of 3 years.	three years
Secondary	Prevalence of non-CF bronchiectasis (NCFB) etiologies (composite outcome measures) across all different levels of health care	Distribution (prevalence) of underlying conditions/etiologies; Clinical presentation of NCFB; Predictors of lung function decline in patients with NCFB; Diagnostics employed in determining the etiology of NCFB; Microbiology of NCFB; Radiology of NCFB; Comorbidity in patients with NCFB; Impact of exacerbations and hospitalizations on the clinical course of NCFB; Prescription patterns of pharmacological respiratory treatments for NCFB; Usage and benefit of surgical procedures in NCFB; Physical therapy and rehabilitation; Healthcare utilization and associated costs in NCFB; QOL(Questions of Life) among patients with NCFB; survival/mortality of NCFB	three years

External Links

•   PROGNOSIS - das deutsche Bronchiektasen-Register