Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4500 participants
OBSERVATIONAL
2011-11-01
2026-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
1. Maintenance treatment with high doses of ICS (\>400 μg budesonide or equivalent / ≥ 200 μg of fluticasone as monotherapy) or
2. Maintenance treatment with medium to high doses of ICS (≥400 μg budesonide or equivalent / ≥ 200 μg fluticasone) combined with LABA and/or LTRA and/or theophylline or
3. Treatment with oral steroids for ≥ 3 months (vii) Poor asthma control:
a. Inadequate symptom in the past 4 weeks: i. asthma symptoms ≥3 x / week or use of rescue medication ≥3 x / week; or ii. activity limitations due to asthma; or iii. any nighttime asthma symptoms; or b. ≥ 1 exacerbation in the last year with ≥ 3 days of OCS treatment or hospitalisation or b. Poor lung function with reduced Tiffeneau index or FEV1 at inclusion (viii) written informed consent (parent or legal guardian)
Exclusion Criteria
Definition: Severe asthma in adults
High level of treatment (A), i.e. step 5 of GINA guideline or (B) medium level of treatment and poor symptom control:
(A) High level of treatment:
1. Maintenance treatment with high-dose inhaled corticosteroids (≥ 1000 μg beclomethasone (BDP, powder) or equivalent) in combination with LABA or LTRA or theophylline or
2. Maintenance treatment with oral corticosteroids (OCS) for ≥3 months independent of other asthma treatments or
3. Treatment with monoclonal antibodies independent of other asthma treatments
B) Medium level of treatment and poor symptom control:
1. Maintenance treatment with medium to high doses of ICS (≥ 500 μg BDP (powder) or equivalent) in combination with LABA or LTRA or theophylline and
2. Poor symptom control:
(i) asthma symptoms ≥ 3 x / week or use of rescue medication ≥ 3 x / week; or (ii) activities limited due to asthma; or (iii) any nighttime asthma symptoms; or (iv) ≥ 1 exacerbation in the last year with ≥ 3 days of OCS treatment or (v) FEV1\<80% of predicted
6 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
GlaxoSmithKline
INDUSTRY
Sanofi
INDUSTRY
Chiesi Farmaceutici S.p.A.
INDUSTRY
German Asthma Net e.V.
OTHER
Responsible Party
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Locations
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Kardiologische und fachinternistische ÜBAG Dr. Sandrock und Partner
Altdorf, , Germany
Universitätsklinikum Augsburg Kinderpulmologie und -allergologie
Augsburg, , Germany
Praxis Dr. Grün
Bad Windsheim, , Germany
CIMS Studienzentrum Bamberg
Bamberg, , Germany
Lungenpraxis Tegel
Berlin, , Germany
Evangelisches Klinikum Bethel v. Bodelschwinghsche Stiftungen Bethel
Bielefeld, , Germany
Helios Lungen- und Allergiezentrum Bonn
Bonn, , Germany
Universitätsnedizin Bonn
Bonn, , Germany
Zentrum für Kinderheilkunde, Klinik und Poliklinik für Allgemeine Pädiatrie, Allergieabteilung
Bonn, , Germany
Lungenpraxis Medicum Böblingen
Böblingen, , Germany
Prof.-Hess-Kinderklinik Bremen-Mitte
Bremen, , Germany
MECS Cottbus
Cottbus, , Germany
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, , Germany
Lunge im Zentrum
Erlangen, , Germany
Universitätsmedizin Essen
Essen, , Germany
Pneumologie am Schelztor Esslingen
Esslingen am Neckar, , Germany
Praxis Dr. Herden
Freising, , Germany
ALB FILS Kliniken
Göppingen, , Germany
Hamburger Institut für Therapieforschung GmbH
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Praxisgmeinschaft Dr. Abenhardt und Jochen Hinrichs-Pavlik
Heidelberg, , Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, , Germany
Lungenarztpraxis Dr. Hubatsch
Heilbronn, , Germany
Atemwegszentrum Kaiserslautern
Kaiserslautern, , Germany
MVZ Klinikum Kempten
Kempten, , Germany
Pneumologische Gemeinschaftspraxis
Koblenz, , Germany
Lungenpraxis Konstanz
Konstanz, , Germany
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau
Landau an der Isar, , Germany
Asthma Allergiezentrum
Leverkusen, , Germany
Lungenfachklinik Medizinische Klinik I, Pneumologie
Löwenstein, , Germany
IKF Pneumologie GmbH & Co. KG
Mainz, , Germany
Lungenfacharztpraxis Dr. C. Lüttecke-Hecht
Mainz, , Germany
Lungenfacharztpraxis Dr. Gall
Mainz, , Germany
Univsersitätsmedizin Mainz
Mainz, , Germany
Dr. von Haunersches Kinderspital
München, , Germany
LMU Klinikum der Universität München, Ambulanz für Schweres Asthma (Erwachsene)
München, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Universitätsmedizin Rostock, Med. Klinik I, Abt. Pneumologie & Interdiszipl. Internistische Intensivmedizin
Rostock, , Germany
Lungenpraxis Schleswig/ Respiratio
Schleswig, , Germany
Ambulante Pneumologie mit Allergiezentrum (BAG)
Stuttgart, , Germany
RBK Lungenzentrum Stuttgart
Stuttgart, , Germany
Internistische Gemeinschaftspraxis Bitburg-Trier
Trier, , Germany
Uniklinik Ulm, Sektion Pneumologie, Klinik für Innere Medizin II
Ulm, , Germany
Fachkliniken Wangen
Wangen, , Germany
Marien-Hospital, Klinik für Kinder- und Jugendmedizin
Wesel, , Germany
Countries
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Central Contacts
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Facility Contacts
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Markus Gasplmayr
Role: primary
Borghild Grün, Dr.
Role: primary
Joachim Kirschner, Dr.
Role: primary
Thomas Hering
Role: primary
Eckard Hamelmann, Prof.
Role: primary
Marcus Joest
Role: primary
Dirk Skowasch, Prof.
Role: primary
Stefan Veitshans, Dr.
Role: primary
Petra Kaiser-Labusch
Role: primary
Frank Käßner, Dr.
Role: primary
Monika Gappa, Prof.
Role: primary
Sabine Lampert, Dr.
Role: primary
Silke Hellmich, Dr.
Role: primary
Markus Herden, Dr.
Role: primary
Timo Deininger, Dr.
Role: primary
Margret Jandl, Dr.
Role: primary
Hendrik Suhling, PD Dr.
Role: primary
Birgit Abenhardt, Dr.
Role: primary
Felix Herdt, Prof.
Role: primary
Florian Schmitz, Dr.
Role: primary
Kim Husemann, Dr.
Role: primary
Olaf Schmidt, Dr.
Role: primary
Christian Geltner, Dr.
Role: primary
Norbert Mülleneisen
Role: primary
Monika Stephan, Dr.
Role: primary
Stephanie Korn, Prof.
Role: primary
Camilla Lüttecke-Hecht, Dr.
Role: primary
Roland Buhl, Prof.
Role: primary
Bianca Schaub, Prof.
Role: primary
Katrin Milger-Kneidinger, PD Dr.
Role: primary
Christian Schulz, Prof.
Role: primary
Andreas Deimling, Dr.
Role: primary
Rainer Ehmann
Role: primary
Claus Neurohr, Dr.
Role: primary
Patrick Albrecht, Dr.
Role: primary
Cornelia Kropf-Sanchen
Role: primary
Susanne Hirschmann
Role: primary
Cordula Körner-Rettberg, Dr.
Role: primary
References
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Bal C, Pohl W, Milger K, Skowasch D, Schulz C, Gappa M, Koerner-Rettberg C, Jandl M, Schmidt O, Zehetmayer S, Taube C, Hamelmann E, Buhl R, Korn S, Idzko M; German Asthma Net (GAN) study group. Characterization of Obesity in Severe Asthma in the German Asthma Net. J Allergy Clin Immunol Pract. 2023 Nov;11(11):3417-3424.e3. doi: 10.1016/j.jaip.2023.06.049. Epub 2023 Jul 4.
Milger K, Suhling H, Skowasch D, Holtdirk A, Kneidinger N, Behr J, Timmermann H, Schulz C, Schmidt O, Ehmann R, Hamelmann E, Idzko M, Taube C, Lommatzsch M, Buhl R, Korn S. Response to Biologics and Clinical Remission in the Adult German Asthma Net Severe Asthma Registry Cohort. J Allergy Clin Immunol Pract. 2023 Sep;11(9):2701-2712.e2. doi: 10.1016/j.jaip.2023.05.047. Epub 2023 Jun 8.
Korn S, Milger K, Skowasch D, Schulz C, Mohrlang C, Wernitz M, Paulsson T, Hennig M, Buhl R. Real-World Experience on the Use of Mepolizumab from the Severe Asthma Registry of the German Asthma Net (MepoGAN-Study). J Asthma Allergy. 2023 May 11;16:541-552. doi: 10.2147/JAA.S403286. eCollection 2023.
Milger K, Skowasch D, Hamelmann E, Mummler C, Idzko M, Gappa M, Jandl M, Korner-Rettberg C, Ehmann R, Schmidt O, Taube C, Holtdirk A, Timmermann H, Buhl R, Korn S. Bronchodilator Reversibility in the GAN Severe Asthma Cohort. J Investig Allergol Clin Immunol. 2023 Dec 14;33(6):446-456. doi: 10.18176/jiaci.0850. Epub 2022 Aug 24.
Bal C, Idzko M, Skrgat S, Koch A, Milger K, Schulz C, Zehetmayer S, Hamelmann E, Buhl R, Korn S; collaborators from the German Asthma Net (GAN). Fraction of exhaled nitric oxide is associated with disease burden in the German Asthma Net severe asthma cohort. Eur Respir J. 2022 Jun 2;59(6):2101233. doi: 10.1183/13993003.01233-2021. Print 2022 Jun.
Related Links
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Website
Other Identifiers
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2018-13614
Identifier Type: -
Identifier Source: org_study_id
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