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RECRUITINGOBSERVATIONAL

Register Schweres Asthma - German Asthma Net e.V.

Klinisches Register Schweres Asthma

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

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 willing to sign a consent form (parent or legal guardian) Who Should NOT Join This Trial: (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: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Locations (20)

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