NCT02574143

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

19 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

5.3 years

First QC Date

July 17, 2015

Last Update Submit

October 26, 2020

Conditions

Keywords

PrognosisProspective StudyQuality of LifeRadiologyRehabilitationRegistry;Signs and SymptomsTherapyBronchiectiasisDiagnosisEpidemiologyEtiologyLongitudinal StudyMicrobiology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Prevalence of non-CF bronchiectasis (NCFB) etiologies (composite outcome measures) across all different levels of health care

    three years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with non-CF bronchiectasis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Helios Klinikum Emil von Behring - Lungenklinik Heckeshorn

Berlin, Germany

NOT YET RECRUITING

Augusta-Kranken-Anstalt Bochum -Klinik für Pneumologie, Beatmungsmedizin und Infektiologie

Bochum, Germany

NOT YET RECRUITING

Fachkrankenhaus Coswig

Coswig, Germany

NOT YET RECRUITING

Klinik Donaustauf - Zentrum für Pneumologie

Donaustauf, Germany

NOT YET RECRUITING

Klinikum Dortmund Medizinische Klinik Nord - Pneumologie, Infektiologie und Internistische Intensivmedizin

Dortmund, Germany

NOT YET RECRUITING

Universitätsklinikum Carl Gustav Carus an der TU Dresden Medizinische Klinik und Poliklinik I, Bereich Pulmologie

Dresden, Germany

NOT YET RECRUITING

Florence-Nightingale-Krankenhaus Klinik für Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin

Düsseldorf, Germany

NOT YET RECRUITING

Praxis am Maingau Krankenhaus Gemeinschaftspraxis für Innere Medizin, Lungen- und Bronchialheilkunde, Allergologie

Frankfurt, Germany

NOT YET RECRUITING

Universitätsklinikum Freiburg Abteilung für Klinische Infektiologie

Freiburg im Breisgau, Germany

NOT YET RECRUITING

UKGM - Standort Gießen Medizinische Klinik und Poliklinik II

Giessen, Germany

NOT YET RECRUITING

LungenClinic Großhansdorf

Großhansdorf, Germany

NOT YET RECRUITING

Medizinische Hochschule Hannover-Klinik für Pneumologie

Hanover, Germany

RECRUITING

Universitätsklinikum Heidelberg und Thoraxklinik Heidelberg

Heidelberg, Germany

NOT YET RECRUITING

Universitätsklinikum Jena Zentrum für Infektionsmedizin und Krankenhaushygiene

Jena, Germany

NOT YET RECRUITING

Universitätsklinikum Schleswig-Holstein Medizinische Klinik III - Pneumologie / Infektiologie

Lübeck, Germany

NOT YET RECRUITING

Klinikum Lüdenscheid Klinik für Pneumologie, Infektiologie, Schlafmedizin und Internistische Intensivmedizin

Lüdenscheid, Germany

NOT YET RECRUITING

Klinikum der Philipps-University Marburg

Marburg, Germany

NOT YET RECRUITING

Klinikum der Ludwig-Maximilians-Universität München

München, Germany

NOT YET RECRUITING

Diakoniekrankenhaus Rotenburg Zentrum für Pneumologie

Rotenburg (Wümme), Germany

NOT YET RECRUITING

Related Publications (1)

  • Ewen R, Pink I, Sutharsan S, Aries SP, Grunewaldt A, Shoemark A, Sommerwerck U, Staar BO, Wege S, Mertsch P, Rademacher J, Ringshausen FC; PROGNOSIS Study Group. Primary Ciliary Dyskinesia in Adult Bronchiectasis: Data from the German Bronchiectasis Registry PROGNOSIS. Chest. 2024 Nov;166(5):938-950. doi: 10.1016/j.chest.2024.05.023. Epub 2024 Jun 15.

Related Links

MeSH Terms

Conditions

BronchiectasisSigns and SymptomsDisease

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Jessica Rademacher

    CAPNETZ STIFTUNG; Medizinische Hochschule Hannover

    STUDY CHAIR
  • Felix C. Ringshausen

    CAPNETZ STIFTUNG; Medizinische Hochschule Hannover

    STUDY CHAIR
  • Andrés de Roux

    Pneumologische Praxis Berlin

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2015

First Posted

October 12, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2020

Study Completion

July 1, 2021

Last Updated

October 27, 2020

Record last verified: 2020-10

Locations