Register Schweres Asthma - German Asthma Net e.V.
- Conditions
- Severe Asthma
- Registration Number
- NCT06035289
- Lead Sponsor
- German Asthma Net e.V.
- Brief Summary
The German Asthma Net e.V. focusses on science and research in patients with severe asthma. This includes, in particular, the optimization of medical care and treatment for patients with severe asthma as well as the elucidation and information. An unavoidable basis for a better understanding of severe asthma is the registration and comprehensive characterization of a large patient population. To date, there are only few reliable data on incidence, prevalence, phenotypes and treatment of patients with severe asthma. For this reason, the German Asthma Net e.V. was established in December 2011 as a clinical registry for patients with severe asthma, initially set up on a national basis.
- Detailed Description
Sociodemographic parameters (e.g., gender, date of birth) and medical parameters (diagnosis, therapy) are entered in the register. In addition, data on lung function, laboratory values (IgE and eosinophil granulocytes), asthma control (symptoms, nocturnal awakenings, on-demand medication, exacerbations), smoking status, and concomitant therapy (inhalable corticosteroids, bronchodilators, and systemic steroids) are collected. This information will be collected at the baseline visit, and then once a year at a follow up visit, for fifteen years.
Participants will be assigned a unique study ID to protect the confidentiality of their personal health care information. Personal data and register data are on separate servers and thus meet the requirements of data protection.
The primary purpose is to establish a clinical registry for patients with severe asthma. The number of patients with severe asthma at a single center or practice is usually small, so several centers (clinics and practices) in Germany have joined together to form the German Asthma Net e.V. to optimize the diagnostic evaluation and treatment of patients with severe asthma.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptom Control Baseline, four months, yearly for up to 15 years Changes in symptom control at baseline and during the follow-up period and at study end using the Asthma Control Test (ACT).
- Secondary Outcome Measures
Name Time Method Asthma Control Questionnaire Baseline, yearly for up to 15 years Asthma Control Questionnaire ACQ: 5 questions, scale 0 to 6, min score 0, max score 30, the lower the score the better the Asthma control)
Fraction of exhaled nitric oxide (FeNo) Baseline, 4 months, yearly for up to 15 years Changes in FeNo in ppb
Eosinophilic granulocytes Baseline, 4 months, yearly for up to 15 years Changes in Eosinophilic granulocytes in µl or %
Exacerbations Baseline, four months, yearly for up to 15 years Number of exacerbation with/without hospitalization
Utilization of the health care system Baseline, yearly for up to 15 years Number of visits at a pneumologist/ specialist, number of emergency consultations, number of hospitalizations, number of rehabilitation stays
Quality of Life Questionnaire Baseline, yearly for up to 15 years Mini Asthma Quality of Life Questionnaire (Mini-AQLQ: 15 questions, scale 1 to 7, min score 15, max score 105, the higher the score, the better the quality of life)
Symptoms and health-related quality of life Baseline, yearly for up to 15 years Asthma Control Test (ACT: 5 questions, scale 1- 5, min score 5, max score 25, the lower the score the better the Asthma control)
Neutrophilic granulocytes Baseline, 4 months, yearly for up to 15 years Changes in Neutrophilic granulocytes in nl or %
CO diffusion capacity Baseline, yearly for up to 15 years Changes in mmol/min/kPa/ %
Forced Vital Capacity (FVC) Baseline, 4 months, yearly for up to 15 years FVC at consultation, FEV1 last 2 years, changes in FEV1 in liter from the target value
Changes in dose in mg 4 months, yearly for up to 15 years Changes in dose in mg
Forced Exhaled Volume in 1 second (FEV1) Baseline, 4 months, yearly for up to 15 years FEV1 at consultation, FEV1 last 2 years, changes in FEV1 in liter from the target value
Changes in medication Baseline, 4 months, yearly for up to 15 years changes in substances if there is a new drug used.
Blood Gas analysis Baseline, 4 months, yearly for up to 15 years Blood-oxygen saturation in %
Leucocytes Baseline, 4 months, yearly for up to 15 years Changes in leucocytes in nl
Trial Locations
- Locations (45)
Praxis Dr. Grün
🇩🇪Bad Windsheim, Germany
Evangelisches Klinikum Bethel v. Bodelschwinghsche Stiftungen Bethel
🇩🇪Bielefeld, Germany
Zentrum für Kinderheilkunde, Klinik und Poliklinik für Allgemeine Pädiatrie, Allergieabteilung
🇩🇪Bonn, Germany
MECS Cottbus
🇩🇪Cottbus, Germany
Pneumologie am Schelztor Esslingen
🇩🇪Esslingen, Germany
Universitätsmedizin Essen
🇩🇪Essen, Germany
ALB FILS Kliniken
🇩🇪Göppingen, Germany
CIMS Studienzentrum Bamberg
🇩🇪Bamberg, Germany
Universitätsnedizin Bonn
🇩🇪Bonn, Germany
Medizinische Hochschule Hannover
🇩🇪Hanover, Germany
Lunge im Zentrum
🇩🇪Erlangen, Germany
LMU Klinikum der Universität München, Ambulanz für Schweres Asthma (Erwachsene)
🇩🇪München, Germany
Helios Lungen- und Allergiezentrum Bonn
🇩🇪Bonn, Germany
Lungenpraxis Konstanz
🇩🇪Konstanz, Germany
Kardiologische und fachinternistische ÜBAG Dr. Sandrock und Partner
🇩🇪Altdorf, Germany
Lungenpraxis Tegel
🇩🇪Berlin, Germany
Pneumologische Gemeinschaftspraxis
🇩🇪Koblenz, Germany
Lungenpraxis Medicum Böblingen
🇩🇪Böblingen, Germany
Evangelisches Krankenhaus Düsseldorf
🇩🇪Düsseldorf, Germany
Lungenarztpraxis Dr. Hubatsch
🇩🇪Heilbronn, Germany
IKF Pneumologie GmbH & Co. KG
🇩🇪Mainz, Germany
Lungenfacharztpraxis Dr. Gall
🇩🇪Mainz, Germany
Uniklinik Ulm, Sektion Pneumologie, Klinik für Innere Medizin II
🇩🇪Ulm, Germany
Praxis Dr. Herden
🇩🇪Freising, Germany
Internistische Gemeinschaftspraxis Bitburg-Trier
🇩🇪Trier, Germany
Universitätsklinikum Augsburg Kinderpulmologie und -allergologie
🇩🇪Augsburg, Germany
Prof.-Hess-Kinderklinik Bremen-Mitte
🇩🇪Bremen, Germany
Hamburger Institut für Therapieforschung GmbH
🇩🇪Hamburg, Germany
Praxisgmeinschaft Dr. Abenhardt und Jochen Hinrichs-Pavlik
🇩🇪Heidelberg, Germany
Atemwegszentrum Kaiserslautern
🇩🇪Kaiserslautern, Germany
Lungenfacharztpraxis Dr. C. Lüttecke-Hecht
🇩🇪Mainz, Germany
MVZ Klinikum Kempten
🇩🇪Kempten, Germany
Thoraxklinik Heidelberg gGmbH
🇩🇪Heidelberg, Germany
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau
🇩🇪Landau an der Isar, Germany
Asthma Allergiezentrum
🇩🇪Leverkusen, Germany
Lungenfachklinik Medizinische Klinik I, Pneumologie
🇩🇪Löwenstein, Germany
Univsersitätsmedizin Mainz
🇩🇪Mainz, Germany
Dr. von Haunersches Kinderspital
🇩🇪München, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Lungenpraxis Schleswig/ Respiratio
🇩🇪Schleswig, Germany
Universitätsmedizin Rostock, Med. Klinik I, Abt. Pneumologie & Interdiszipl. Internistische Intensivmedizin
🇩🇪Rostock, Germany
Ambulante Pneumologie mit Allergiezentrum (BAG)
🇩🇪Stuttgart, Germany
RBK Lungenzentrum Stuttgart
🇩🇪Stuttgart, Germany
Fachkliniken Wangen
🇩🇪Wangen Im Allgäu, Germany
Marien-Hospital, Klinik für Kinder- und Jugendmedizin
🇩🇪Wesel, Germany