PROGNOSIS - THE PROSPECTIVE GERMAN NON-CF BRONCHIECTASIS PATIENT REGISTRY
The PROGNOSIS-Register-Study means a German-wide, national, representative, prospective, observed and longitudinal database is constructed. In a time span of 3 years, at least 750 patients are included within the non-CF bronchiectasis register at 25 study centers.
PROGNOSIS works in close cooperation with the European bronchiectasis register EMBARC (The European Multicentre Bronchiectasis Audit and Research Collaboration, www.bronchiectasis.eu) which in turn is funded by the European specialist association the European Respiratory Society (ERS), as the Clinical Research Collaboration. The data from PROGNOSIS represents Germany within the European bronchiectasis register EMBARC.
The subject of non-CF bronchiectasis is highly rated at the Hannover Medical School (MHH), and the building-up of the PROGNOSIS register is significantly initiated and coordinated by the medical staff at the MHH .The team leaders for the planning and implementation of the register studies therefore, have competent support in their activities.
Support for the marketing and PR work concerning the project comes from BREATH (Biomedical Research in Endstage and Obstructive Lung Disease Hannover), the home of the German centre for lung research (DZL) at the MHH.
The DZL-partner, the CAPNETZ STIFTUNG supports the German Bronchiectasis-Register PROGNOSIS within the framework of programming the study data bank, for clinical data acquisition, the submitting of study documentation to the authorities, the recruiting of participating centres management and the collaboration of the participating centers within the scientific network.
The intensive collaboration of affected patients of non-CF-bronchiectasis is of special importance to PROGNOSIS as also the patient’s organisations the German Respiratory League and the German Patients League for Respiratory Diseases (Deutsche Atemwegsliga e. V., Deutsche Patientenliga Atemwegserkrankungen e. V.) and a group of patients who advise the Register. PROGNOSIS offers affected patients a contact point at which suitable information is on offer and which supports them in organizing themselves in order to favourably influence the course of the disease.
Further information can be found on the PROGNOSIS bronchiektasis register public homepage: www.bronchiektasen-register.de
Non-CF Bronchiectasis – Study Situation
Not through a cysticfibrosis (CF) caused bronchiectasis (Non-CF-bronchiectasis)...
Because of the excessive lack of epidemiological, basic scientific and clinical studies on CF-bronchiectasis the data situation for most of the applied therapies is insubstantial. This can be particularly expressed in the fact that in 2015 no approved pharmacological treatments exist for this indication and necessary regulations besides the actual authorization ("off-label") must take place.
- constitutes heterogeneous disease complexes with many fundamental causes and corresponding frequent diagnostic and therapeutic challenges
- are characterized by permanent dilation of the bronchi and bronchioles and the never ending circle of chronic infection and inflammation, secretion behavior and damage to the respiratory tracts
- concerns causes of substantial clinical complaints and chronic progressive courses, the extraordinary burdens and constraints of the every-day life of the affected patients.
Aims of PROGNOSIS
The German Bronchiectasis-Register PROGNOSIS (The Prospective German Non-CF-Bronchiectasis Registry) began to recruit the first patients in the third quarter of 2015. Among other things the aims of PROGNOSIS are:
Recruiting within the PROGNOSIS project begins first of all at the 17 foundation centers with the aim of gaining 250 adult patients in the first year. One of the next steps should be at least 10 -20 further centres also including pneumological practices to be initiated in order to achieve the recruitment target of 750 patients in 3 years.
- The building up and expansion of a Germany wide, representative, prospective, observing (non-interventional) and longitudinal patient register, in which the database will include 750 adult patients recruited from 25-35 centres with overlapping sectors, meaning, from pneumological practices up to university clinics within a period of 3 years.
- Answering important epidemiological questions for example the distribution of aetiologies and the acquisition of non-bronchiectasis current care realities – (including quality of life, health economy and pharma-coepidemiology).
- Establishing a schema for differential diagnosis as also prognostic markers for non bronchiectasis.
- Facilitating the access to future clinical studies for participating centers,
- The creation of German-speaking guidelines for the diagnosis and management of non-CF-bronchiectasis in collaboration with the German Association for Pneumology and Respiratory Medicine (DGP)
- Support for the building-up of a translational research network concerning non-CF-Bronchiectasis in Germany and Europe.
- CAPNETZ STIFTUNG
- Hannover Medical School (Medizinische Hochschule Hannover (MHH))
- German Association for Pneumology (Deutsche Gesellschaft für Pneumologie (DGP))
- German Respiratory League (Deutsche Atemwegsliga e. V.)
- German Patient’s League for Respiratory Tract Diseases (Deutsche Patientenliga Atemwegserkrankungen e. V. (DPLA))
- European Respiratory Society (ERS)