The PROspective German NOn-CF bronchiectaSIS Patient Registry (PROGNOSIS)

October 26, 2020 updated by: Hannover Medical School
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Berlin, Germany
        • Not yet recruiting
        • Helios Klinikum Emil von Behring - Lungenklinik Heckeshorn
      • Bochum, Germany
        • Not yet recruiting
        • Augusta-Kranken-Anstalt Bochum -Klinik für Pneumologie, Beatmungsmedizin und Infektiologie
      • Coswig, Germany
        • Not yet recruiting
        • Fachkrankenhaus Coswig
      • Donaustauf, Germany
        • Not yet recruiting
        • Klinik Donaustauf - Zentrum für Pneumologie
      • Dortmund, Germany
        • Not yet recruiting
        • Klinikum Dortmund Medizinische Klinik Nord - Pneumologie, Infektiologie und Internistische Intensivmedizin
      • Dresden, Germany
        • Not yet recruiting
        • Universitätsklinikum Carl Gustav Carus an der TU Dresden Medizinische Klinik und Poliklinik I, Bereich Pulmologie
      • Düsseldorf, Germany
        • Not yet recruiting
        • Florence-Nightingale-Krankenhaus Klinik für Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin
      • Frankfurt, Germany
        • Not yet recruiting
        • Praxis am Maingau Krankenhaus Gemeinschaftspraxis für Innere Medizin, Lungen- und Bronchialheilkunde, Allergologie
      • Freiburg, Germany
        • Not yet recruiting
        • Universitätsklinikum Freiburg Abteilung für Klinische Infektiologie
      • Giessen, Germany
        • Not yet recruiting
        • UKGM - Standort Gießen Medizinische Klinik und Poliklinik II
      • Großhansdorf, Germany
        • Not yet recruiting
        • LungenClinic Grosshansdorf
      • Hannover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover-Klinik für Pneumologie
      • Heidelberg, Germany
        • Not yet recruiting
        • Universitätsklinikum Heidelberg und Thoraxklinik Heidelberg
      • Jena, Germany
        • Not yet recruiting
        • Universitätsklinikum Jena Zentrum für Infektionsmedizin und Krankenhaushygiene
      • Lübeck, Germany
        • Not yet recruiting
        • Universitätsklinikum Schleswig-Holstein Medizinische Klinik III - Pneumologie / Infektiologie
      • Lüdenscheid, Germany
        • Not yet recruiting
        • Klinikum Lüdenscheid Klinik für Pneumologie, Infektiologie, Schlafmedizin und Internistische Intensivmedizin
      • Marburg, Germany
        • Not yet recruiting
        • Klinikum der Philipps-University Marburg
      • München, Germany
        • Not yet recruiting
        • Klinikum der Ludwig-Maximilians-Universität München
      • Rotenburg, Germany
        • Not yet recruiting
        • Diakoniekrankenhaus Rotenburg Zentrum für Pneumologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with non-CF bronchiectasis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with non-CF bronchiectasis (NCFB) across all different levels of health care regarding the current management of NCFB in Germany
Time Frame: 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.
three years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of non-CF bronchiectasis (NCFB) etiologies (composite outcome measures) across all different levels of health care
Time Frame: 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
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hannover Medical School

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Center for Lung Research
Capnetz Stiftung

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PROGNOSIS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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