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Severe AsthmaNCT06035289

Register Schweres Asthma - German Asthma Net e.V.

An observational study of Severe Asthma, run by German Asthma Net e.V. at 45 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Severe Asthma
How many people
4,500 participants
Where
45 sitesGermany
Study dates
1 Nov 2011to 1 Nov 2026
How long will I take part?
1 Year
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 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

None listed.

Who cannot join

  • Diagnosis of other obstructive or systemic pulmonary diseases (e.g. cystic fibrosis, COPD) despite BPD at inclusion (ii) Other congenital lung diseases or pulmonary malformations (iii) Other significant chronic diseases (iv) Congenital or acquired heart defects with significant functional limitations
  • 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:
  • 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
Show all 11Show fewer
  • Treatment with monoclonal antibodies independent of other asthma treatments
  • 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:
  • 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

Trial locations and contacts

45 sites in 1 country.

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

45 sites in 1 country

Germany45 sites, 38 recruiting

  • Kardiologische und fachinternistische ÜBAG Dr. Sandrock und Partner

    Altdorf

    Markus Gasplmayr

    Recruiting

  • Universitätsklinikum Augsburg Kinderpulmologie und -allergologie

    Augsburg

    Active, not recruiting

  • Praxis Dr. Grün

    Bad Windsheim

    Borghild Grün, Dr.

    Recruiting

  • CIMS Studienzentrum Bamberg

    Bamberg

    Joachim Kirschner, Dr.

    Recruiting

  • Lungenpraxis Tegel

    Berlin

    Thomas Hering

    Recruiting

  • Evangelisches Klinikum Bethel v. Bodelschwinghsche Stiftungen Bethel

    Bielefeld

    Eckard Hamelmann, Prof.

    Recruiting

  • Lungenpraxis Medicum Böblingen

    Böblingen

    Stefan Veitshans, Dr.

    Recruiting

  • Helios Lungen- und Allergiezentrum Bonn

    Bonn

    Marcus Joest

    Recruiting

  • Universitätsnedizin Bonn

    Bonn

    Dirk Skowasch, Prof.

    Recruiting

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

    Bonn

    Active, not recruiting

  • Prof.-Hess-Kinderklinik Bremen-Mitte

    Bremen

    Petra Kaiser-Labusch

    Recruiting

  • MECS Cottbus

    Cottbus

    Frank Käßner, Dr.

    Recruiting

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf

    Monika Gappa, Prof.

    Recruiting

  • Lunge im Zentrum

    Erlangen

    Sabine Lampert, Dr.

    Recruiting

  • Universitätsmedizin Essen

    Essen

    Active, not recruiting

  • Pneumologie am Schelztor Esslingen

    Esslingen am Neckar

    Silke Hellmich, Dr.

    Recruiting

  • Praxis Dr. Herden

    Freising

    Markus Herden, Dr.

    Recruiting

  • ALB FILS Kliniken

    Göppingen

    Timo Deininger, Dr.

    Recruiting

  • Hamburger Institut für Therapieforschung GmbH

    Hamburg

    Margret Jandl, Dr.

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover

    Hendrik Suhling, PD Dr.

    Recruiting

  • Praxisgmeinschaft Dr. Abenhardt und Jochen Hinrichs-Pavlik

    Heidelberg

    Birgit Abenhardt, Dr.

    Recruiting

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg

    Felix Herdt, Prof.

    Recruiting

  • Lungenarztpraxis Dr. Hubatsch

    Heilbronn

    Active, not recruiting

  • Atemwegszentrum Kaiserslautern

    Kaiserslautern

    Florian Schmitz, Dr.

    Recruiting

  • MVZ Klinikum Kempten

    Kempten

    Kim Husemann, Dr.

    Recruiting

  • Pneumologische Gemeinschaftspraxis

    Koblenz

    Olaf Schmidt, Dr.

    Recruiting

  • Lungenpraxis Konstanz

    Konstanz

    Active, not recruiting

  • DONAUISAR Klinikum Deggendorf-Dingolfing-Landau

    Landau an der Isar

    Christian Geltner, Dr.

    Recruiting

  • Asthma Allergiezentrum

    Leverkusen

    Norbert Mülleneisen

    Recruiting

  • Lungenfachklinik Medizinische Klinik I, Pneumologie

    Löwenstein

    Monika Stephan, Dr.

    Recruiting

  • IKF Pneumologie GmbH & Co. KG

    Mainz

    Stephanie Korn, Prof.

    Recruiting

  • Lungenfacharztpraxis Dr. C. Lüttecke-Hecht

    Mainz

    Camilla Lüttecke-Hecht, Dr.

    Recruiting

  • Lungenfacharztpraxis Dr. Gall

    Mainz

    Active, not recruiting

  • Univsersitätsmedizin Mainz

    Mainz

    Roland Buhl, Prof.

    Recruiting

  • Dr. von Haunersches Kinderspital

    München

    Bianca Schaub, Prof.

    Recruiting

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

    München

    Katrin Milger-Kneidinger, PD Dr.

    Recruiting

  • Universitätsklinikum Regensburg

    Regensburg

    Christian Schulz, Prof.

    Recruiting

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

    Rostock

    Active, not recruiting

  • Lungenpraxis Schleswig/ Respiratio

    Schleswig

    Andreas Deimling, Dr.

    Recruiting

  • Ambulante Pneumologie mit Allergiezentrum (BAG)

    Stuttgart

    Rainer Ehmann

    Recruiting

  • RBK Lungenzentrum Stuttgart

    Stuttgart

    Claus Neurohr, Dr.

    Recruiting

  • Internistische Gemeinschaftspraxis Bitburg-Trier

    Trier

    Patrick Albrecht, Dr.

    Recruiting

  • Uniklinik Ulm, Sektion Pneumologie, Klinik für Innere Medizin II

    Ulm

    Cornelia Kropf-Sanchen

    Recruiting

  • Fachkliniken Wangen

    Wangen

    Susanne Hirschmann

    Recruiting

  • Marien-Hospital, Klinik für Kinder- und Jugendmedizin

    Wesel

    Cordula Körner-Rettberg, Dr.

    Recruiting

Other trials in Germany

About this study

Official title: Klinisches Register Schweres Asthma

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.

Read the 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.

Conditions
Severe Asthma
Keywords
Registry, Biological
Medical subject headings
Asthma

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline, four months, yearly for up to 15 years

Secondary outcomes (16)

  1. Exacerbations

    Number of exacerbation with/without hospitalization

    Measured: Baseline, four months, yearly for up to 15 years

  2. Utilization of the health care system

    Number of visits at a pneumologist/ specialist, number of emergency consultations, number of hospitalizations, number of rehabilitation stays

    Measured: Baseline, yearly for up to 15 years

  3. Symptoms and health-related quality of life

    Asthma Control Test (ACT: 5 questions, scale 1- 5, min score 5, max score 25, the lower the score the better the Asthma control)

    Measured: Baseline, yearly for up to 15 years

  4. Quality of Life Questionnaire

    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)

    Measured: Baseline, yearly for up to 15 years

  5. Asthma Control Questionnaire

    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)

    Measured: Baseline, yearly for up to 15 years

  6. Forced Exhaled Volume in 1 second (FEV1)

    FEV1 at consultation, FEV1 last 2 years, changes in FEV1 in liter from the target value

    Measured: Baseline, 4 months, yearly for up to 15 years

  7. Forced Vital Capacity (FVC)

    FVC at consultation, FEV1 last 2 years, changes in FEV1 in liter from the target value

    Measured: Baseline, 4 months, yearly for up to 15 years

  8. Changes in medication

    changes in substances if there is a new drug used.

    Measured: Baseline, 4 months, yearly for up to 15 years

  9. Changes in dose in mg

    Changes in dose in mg

    Measured: 4 months, yearly for up to 15 years

  10. Fraction of exhaled nitric oxide (FeNo)

    Changes in FeNo in ppb

    Measured: Baseline, 4 months, yearly for up to 15 years

  11. Blood Gas analysis

    pO2 in kPa/ mmHg, pCO2 in kPa/ mmHg

    Measured: Baseline, 4 months, yearly for up to 15 years

  12. Blood Gas analysis

    Blood-oxygen saturation in %

    Measured: Baseline, 4 months, yearly for up to 15 years

  13. Leucocytes

    Changes in leucocytes in nl

    Measured: Baseline, 4 months, yearly for up to 15 years

  14. Neutrophilic granulocytes

    Changes in Neutrophilic granulocytes in nl or %

    Measured: Baseline, 4 months, yearly for up to 15 years

  15. Eosinophilic granulocytes

    Changes in Eosinophilic granulocytes in µl or %

    Measured: Baseline, 4 months, yearly for up to 15 years

  16. CO diffusion capacity

    Changes in mmol/min/kPa/ %

    Measured: Baseline, yearly for up to 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start1 Nov 2011
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
4,500 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06035289
Sponsor's protocol ID
2018-13614
Other IDs
2018
Status last verified
Oct 2024
First submitted
25 Jul 2023
Last updated
2 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37406803

  • 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.

    PubMed 37301433

  • 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.

    PubMed 37197193

  • 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.

    PubMed 36000830

  • 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.

    PubMed 35273030

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Asthma, run by German Asthma Net e.V. at 45 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 0 inclusion and 11 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 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 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 Stephanie Korn, Prof. (+49 (0)1577-6948673, info@german-asthma-net.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom Control (time frame: Baseline, four months, yearly for up to 15 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 NCT06035289, which also lists 5 linked publications.

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 2 Oct 2024.

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