The PROspective German NOn-CF bronchiectaSIS Patient Registry

• Conditions: Bronchiectasis

• Registration Number: NCT02574143
• Lead Sponsor: Hannover Medical School

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-27
• Primary Completion: 2020-11
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• A clinical history consistent with bronchiectasis
• (High resolution) computed tomography (CT) scan of the chest demonstrating bronchiectasis affecting 1 or more lobes

Read More

Exclusion Criteria

• Bronchiectasis due to known cystic fibrosis (CF)
• Age <18 years
• Interstitial lung disease
• Prior lung or heart-lung transplantation

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with non-CF bronchiectasis (NCFB) across all different levels of health care regarding the current management of NCFB in Germany	three years	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence of non-CF bronchiectasis (NCFB) etiologies (composite outcome measures) across all different levels of health care	three years	* 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

Trial Locations

Locations (19)

Helios Klinikum Emil von Behring - Lungenklinik Heckeshorn; 🇩🇪 Berlin, 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

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

Universitätsklinikum Freiburg Abteilung für Klinische Infektiologie; 🇩🇪 Freiburg, Germany

Medizinische Hochschule Hannover-Klinik für Pneumologie; 🇩🇪 Hannover, Germany

LungenClinic Großhansdorf; 🇩🇪 Großhansdorf, 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

Diakoniekrankenhaus Rotenburg Zentrum für Pneumologie; 🇩🇪 Rotenburg, Germany

Klinikum der Ludwig-Maximilians-Universität München; 🇩🇪 München, Germany

UKGM - Standort Gießen Medizinische Klinik und Poliklinik II; 🇩🇪 Giessen, Germany

Klinikum der Philipps-University Marburg; 🇩🇪 Marburg, Germany