BronchiectasisPROGNOSISNCT02574143
The PROspective German NOn-CF bronchiectaSIS Patient Registry
An observational study of Bronchiectasis, run by Hannover Medical School at 19 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- How many people
- 750 participants
- Where
- 19 sitesGermany
- Study dates
- Jul 2015to Jul 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-CF bronchiectasis
Who may be able to join
- A clinical history consistent with bronchiectasis
- (High resolution) computed tomography (CT) scan of the chest demonstrating bronchiectasis affecting 1 or more lobes
Who cannot join
- Bronchiectasis due to known cystic fibrosis (CF)
- Age <18 years
- Interstitial lung disease
- Prior lung or heart-lung transplantation
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Germany19 sites, 19 recruiting
- Not yet recruiting
Helios Klinikum Emil von Behring - Lungenklinik Heckeshorn
Berlin
- Not yet recruiting
Augusta-Kranken-Anstalt Bochum -Klinik für Pneumologie, Beatmungsmedizin und Infektiologie
Bochum
- Not yet recruiting
Fachkrankenhaus Coswig
Coswig
- Not yet recruiting
Klinik Donaustauf - Zentrum für Pneumologie
Donaustauf
- Not yet recruiting
Klinikum Dortmund Medizinische Klinik Nord - Pneumologie, Infektiologie und Internistische Intensivmedizin
Dortmund
- Not yet recruiting
Universitätsklinikum Carl Gustav Carus an der TU Dresden Medizinische Klinik und Poliklinik I, Bereich Pulmologie
Dresden
- Not yet recruiting
Florence-Nightingale-Krankenhaus Klinik für Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin
Düsseldorf
- Not yet recruiting
Praxis am Maingau Krankenhaus Gemeinschaftspraxis für Innere Medizin, Lungen- und Bronchialheilkunde, Allergologie
Frankfurt
- Not yet recruiting
Universitätsklinikum Freiburg Abteilung für Klinische Infektiologie
Freiburg im Breisgau
- Not yet recruiting
UKGM - Standort Gießen Medizinische Klinik und Poliklinik II
Giessen
- Not yet recruiting
LungenClinic Großhansdorf
Großhansdorf
- Recruiting
Medizinische Hochschule Hannover-Klinik für Pneumologie
Hanover
- Not yet recruiting
Universitätsklinikum Heidelberg und Thoraxklinik Heidelberg
Heidelberg
- Not yet recruiting
Universitätsklinikum Jena Zentrum für Infektionsmedizin und Krankenhaushygiene
Jena
- Not yet recruiting
Universitätsklinikum Schleswig-Holstein Medizinische Klinik III - Pneumologie / Infektiologie
Lübeck
- Not yet recruiting
Klinikum Lüdenscheid Klinik für Pneumologie, Infektiologie, Schlafmedizin und Internistische Intensivmedizin
Lüdenscheid
- Not yet recruiting
Klinikum der Philipps-University Marburg
Marburg
- Not yet recruiting
Klinikum der Ludwig-Maximilians-Universität München
München
- Not yet recruiting
Diakoniekrankenhaus Rotenburg Zentrum für Pneumologie
Rotenburg (Wümme)
About this study
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.
Read the 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
- Conditions
- Bronchiectasis
- Keywords
- Prognosis, Prospective Study, Quality of Life, Radiology, Rehabilitation, Registry;, Signs and Symptoms, Therapy, Bronchiectiasis, Diagnosis, Epidemiology, Etiology, Longitudinal Study, Microbiology
- Medical subject headings
- Bronchiectasis, Signs and Symptoms, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three years
Secondary outcomes (1)
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
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Capnetz Stiftung, German Center for Lung Research
- Responsible party
- Sponsor
- Investigators
- Jessica Rademacher, Study chair, CAPNETZ STIFTUNG; Medizinische Hochschule HannoverFelix C. Ringshausen, Study chair, CAPNETZ STIFTUNG; Medizinische Hochschule HannoverAndrés de Roux, Study chair, Pneumologische Praxis Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574143
- Sponsor's protocol ID
- PROGNOSIS
- Acronym
- PROGNOSIS
- Status last verified
- Oct 2020
- First submitted
- 17 Jul 2015
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38880279
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PROspective German NOn-CF bronchiectaSIS Patient Registry
- ClinicalTrials.gov ID
- NCT02574143
- Acronym / sponsor ID
- PROGNOSIS / PROGNOSIS
- Conditions
- Bronchiectasis
- Keywords
- Prognosis, Prospective Study, Quality of Life, Radiology, Rehabilitation, Registry;, Signs and Symptoms, Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Capnetz Stiftung, German Center for Lung Research
- Study start
- Jul 2015
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-CF bronchiectasis
Key inclusion criteria (2 listed)
- A clinical history consistent with bronchiectasis
- (High resolution) computed tomography (CT) scan of the chest demonstrating bronchiectasis affecting 1 or more lobes
Key exclusion criteria (4 listed)
- Bronchiectasis due to known cystic fibrosis (CF)
- Age <18 years
- Interstitial lung disease
- Prior lung or heart-lung transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Prevalence of non-CF bronchiectasis (NCFB) etiologies (composite outcome measures) across all different levels of health care
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Derived from this study: PubMed 38880279Ewen 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.
- PROGNOSIS - das deutsche Bronchiektasen-RegisterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Rademacher study chair
CAPNETZ STIFTUNG; Medizinische Hochschule Hannover
Felix C. Ringshausen study chair
CAPNETZ STIFTUNG; Medizinische Hochschule Hannover
Andrés de Roux study chair
Pneumologische Praxis Berlin
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Hannover Medical School at 19 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grit Barten (+49 511 5324434, prognosis@capnetz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.