Register Schweres Asthma - German Asthma Net e.V.

NCT06035289 | Recruiting

• 1 other identifier: 2018-13614
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 45

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.

Conditions

Severe Asthma

Keywords

Registry; Biological

Outcome Measures

Primary Outcomes (1)

• Symptom Control

  Changes in symptom control at baseline and during the follow-up period and at study end using the Asthma Control Test (ACT).

  Baseline, four months, yearly for up to 15 years

Secondary Outcomes (16)

• Exacerbations

  Baseline, four months, yearly for up to 15 years

• Utilization of the health care system

  Baseline, yearly for up to 15 years

• Symptoms and health-related quality of life

  Baseline, yearly for up to 15 years

• Quality of Life Questionnaire

  Baseline, yearly for up to 15 years

• Asthma Control Questionnaire

  Baseline, yearly for up to 15 years

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to participating study center (pulmonologists in private practice or in pulmonary departments in hospital)

You may not qualify if:

• 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:
• Maintenance treatment with high-dose inhaled corticosteroids (≥ 1000 μg beclomethasone (BDP, powder) or equivalent) in combination with LABA or LTRA or theophylline or
• Maintenance treatment with oral corticosteroids (OCS) for ≥3 months independent of other asthma treatments or
• Treatment with monoclonal antibodies independent of other asthma treatments
• B) Medium level of treatment and poor symptom control:
• Maintenance treatment with medium to high doses of ICS (≥ 500 μg BDP (powder) or equivalent) in combination with LABA or LTRA or theophylline and
• 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

Sponsors & Collaborators

• German Asthma Net e.V.: lead
• AstraZeneca: collaborator
• GlaxoSmithKline: collaborator
• Sanofi: collaborator
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (45)

Kardiologische und fachinternistische ÜBAG Dr. Sandrock und Partner

Altdorf, Germany

RECRUITING

Universitätsklinikum Augsburg Kinderpulmologie und -allergologie

Augsburg, Germany

ACTIVE NOT RECRUITING

Praxis Dr. Grün

Bad Windsheim, Germany

RECRUITING

CIMS Studienzentrum Bamberg

Bamberg, Germany

RECRUITING

Lungenpraxis Tegel

Berlin, Germany

RECRUITING

Evangelisches Klinikum Bethel v. Bodelschwinghsche Stiftungen Bethel

Bielefeld, Germany

RECRUITING

Helios Lungen- und Allergiezentrum Bonn

Bonn, Germany

RECRUITING

Universitätsnedizin Bonn

Bonn, Germany

RECRUITING

Zentrum für Kinderheilkunde, Klinik und Poliklinik für Allgemeine Pädiatrie, Allergieabteilung

Bonn, Germany

ACTIVE NOT RECRUITING

Lungenpraxis Medicum Böblingen

Böblingen, Germany

RECRUITING

Prof.-Hess-Kinderklinik Bremen-Mitte

Bremen, Germany

RECRUITING

MECS Cottbus

Cottbus, Germany

RECRUITING

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, Germany

RECRUITING

Lunge im Zentrum

Erlangen, Germany

RECRUITING

Universitätsmedizin Essen

Essen, Germany

ACTIVE NOT RECRUITING

Pneumologie am Schelztor Esslingen

Esslingen am Neckar, Germany

RECRUITING

Praxis Dr. Herden

Freising, Germany

RECRUITING

ALB FILS Kliniken

Göppingen, Germany

RECRUITING

Hamburger Institut für Therapieforschung GmbH

Hamburg, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, Germany

RECRUITING

Praxisgmeinschaft Dr. Abenhardt und Jochen Hinrichs-Pavlik

Heidelberg, Germany

RECRUITING

Thoraxklinik Heidelberg gGmbH

Heidelberg, Germany

RECRUITING

Lungenarztpraxis Dr. Hubatsch

Heilbronn, Germany

ACTIVE NOT RECRUITING

Atemwegszentrum Kaiserslautern

Kaiserslautern, Germany

RECRUITING

MVZ Klinikum Kempten

Kempten, Germany

RECRUITING

Pneumologische Gemeinschaftspraxis

Koblenz, Germany

RECRUITING

Lungenpraxis Konstanz

Konstanz, Germany

ACTIVE NOT RECRUITING

DONAUISAR Klinikum Deggendorf-Dingolfing-Landau

Landau an der Isar, Germany

RECRUITING

Asthma Allergiezentrum

Leverkusen, Germany

RECRUITING

Lungenfachklinik Medizinische Klinik I, Pneumologie

Löwenstein, Germany

RECRUITING

IKF Pneumologie GmbH & Co. KG

Mainz, Germany

RECRUITING

Lungenfacharztpraxis Dr. C. Lüttecke-Hecht

Mainz, Germany

RECRUITING

Lungenfacharztpraxis Dr. Gall

Mainz, Germany

ACTIVE NOT RECRUITING

Univsersitätsmedizin Mainz

Mainz, Germany

RECRUITING

Dr. von Haunersches Kinderspital

München, Germany

RECRUITING

LMU Klinikum der Universität München, Ambulanz für Schweres Asthma (Erwachsene)

München, Germany

RECRUITING

Universitätsklinikum Regensburg

Regensburg, Germany

RECRUITING

Universitätsmedizin Rostock, Med. Klinik I, Abt. Pneumologie & Interdiszipl. Internistische Intensivmedizin

Rostock, Germany

ACTIVE NOT RECRUITING

Lungenpraxis Schleswig/ Respiratio

Schleswig, Germany

RECRUITING

Ambulante Pneumologie mit Allergiezentrum (BAG)

Stuttgart, Germany

RECRUITING

RBK Lungenzentrum Stuttgart

Stuttgart, Germany

RECRUITING

Internistische Gemeinschaftspraxis Bitburg-Trier

Trier, Germany

RECRUITING

Uniklinik Ulm, Sektion Pneumologie, Klinik für Innere Medizin II

Ulm, Germany

RECRUITING

Fachkliniken Wangen

Wangen, Germany

RECRUITING

Marien-Hospital, Klinik für Kinder- und Jugendmedizin

Wesel, Germany

RECRUITING

Related Publications (5)

• 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.

  PMID: 37406803 RESULT

• 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.

  PMID: 37301433 RESULT

• 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.

  PMID: 37197193 RESULT

• 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.

  PMID: 36000830 RESULT

• 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.

  PMID: 35273030 RESULT

Related Links

• Website

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Stephanie Korn, Prof.

CONTACT

+49 (0)1577-6948673; info@german-asthma-net.de

Mandy Seefeldt

CONTACT

+49 (0)1577-6948673; mandy.seefeldt@german-asthma-net.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: September 13, 2023
• Study Start: November 1, 2011
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

DE (45)