Register Schweres Asthma - German Asthma Net e.V.
Recruiting · NCT06035289 · Observational (researchers observe without assigning treatment) · Lead sponsor: German Asthma Net e.V.
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
6 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Eligibility criteria (as published)
Definition: Severe asthma in children and adolescents
Poor symptom control in the last year despite (medium to) high doses of anti-inflammatory maintenance treatment:
(i) Age 6-18 years (at inclusion) (ii) Asthma diagnosis made by a medical doctor (iii) Potential differential diagnoses excluded (iv) Good compliance and trained inhalation technique (v) Evidence of:
a. Positive bronchodilator reversibility testing (≥ 12% increase in FEV1 after SABA) or b. Significant bronchial hyperreactivity (BHR) after unspecific provocation test (e.g. methacholine challenge or treadmill) according to ATS criteria (Am J Respir Crit Care Med 2000) (vi) High level of treatment:
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:
(i) 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:
(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
Where it is running
45 locations listed.
- 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
- Prof.-Hess-Kinderklinik Bremen-Mitte - Bremen, Germany
- Lungenpraxis Medicum Böblingen - Böblingen, 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