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NCT06035289 | RECRUITING | Severe Asthma

Severe Asthma Register - German Asthma Net e.V.
Sponsor:

German Asthma Net e.V.

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.

Condition or disease

Severe Asthma

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 4500 participants
Official Title : Clinical Registry Severe Asthma
Actual Study Start Date : 2011-11-01
Estimated Primary Completion Date : 2026-11-01
Estimated Study Completion Date : 2026-11-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
    • Severe Asthma Register - German Asthma Net e.V.

    Location Details

    NCT06035289

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    Germany,

    Cardiology and internal medicine ÜBAG Dr. Sandrock and partners

    Altdorf, Germany,

    ACTIVE NOT RECRUITING

    Germany,

    Augsburg University Hospital Pediatric Pulmonology and Allergology

    Augsburg, Germany,

    RECRUITING

    Germany,

    Practice Dr. Green

    Bad Windsheim, Germany,

    RECRUITING

    Germany,

    CIMS Study Center Bamberg

    Bamberg, Germany,

    RECRUITING

    Germany,

    Tegel Lung Practice

    Berlin, Germany,

    RECRUITING

    Germany,

    Evangelical Hospital Bethel v. Bodelschwinghsche Foundations Bethel

    Bielefeld, Germany,

    RECRUITING

    Germany,

    Helios Lung and Allergy Center Bonn

    Bonn, Germany,

    RECRUITING

    Germany,

    Bonn University Medical Center

    Bonn, Germany,

    ACTIVE NOT RECRUITING

    Germany,

    Center for Pediatrics, Clinic and Polyclinic for General Pediatrics, Allergy Department

    Bonn, Germany,

    RECRUITING

    Germany,

    Lung practice Medicum Böblingen

    Böblingen, Germany,

    RECRUITING

    Germany,

    Prof. Hess Children's Clinic Bremen-Mitte

    Bremen, Germany,

    RECRUITING

    Germany,

    MECS Cottbus

    Cottbus, Germany,

    RECRUITING

    Germany,

    Evangelical Hospital Düsseldorf

    Düsseldorf, Germany,

    RECRUITING

    Germany,

    Lung in the center

    Erlangen, Germany,

    ACTIVE NOT RECRUITING

    Germany,

    University Medicine Essen

    Essen, Germany,

    RECRUITING

    Germany,

    Pulmonology at Schelztor Esslingen

    Esslingen am Neckar, Germany,

    RECRUITING

    Germany,

    Practice Dr. herds

    Freising, Germany,

    RECRUITING

    Germany,

    ALB FILS clinics

    Göppingen, Germany,

    RECRUITING

    Germany,

    Hamburg Institute for Therapy Research GmbH

    Hamburg, Germany,

    RECRUITING

    Germany,

    Hannover Medical School

    Hanover, Germany,

    RECRUITING

    Germany,

    Practice group Dr. Abenhardt and Jochen Hinrichs-Pavlik

    Heidelberg, Germany,

    RECRUITING

    Germany,

    Thoraxklinik Heidelberg gGmbH

    Heidelberg, Germany,

    ACTIVE NOT RECRUITING

    Germany,

    Pulmonary practice Dr. Hubatsch

    Heilbronn, Germany,

    RECRUITING

    Germany,

    Kaiserslautern Respiratory Center

    Kaiserslautern, Germany,

    RECRUITING

    Germany,

    MVZ Kempten Clinic

    Kempten, Germany,

    RECRUITING

    Germany,

    Pulmonological group practice

    Koblenz, Germany,

    ACTIVE NOT RECRUITING

    Germany,

    Lung practice Konstanz

    Constancy, Germany,

    RECRUITING

    Germany,

    DONAUISAR Clinic Deggendorf-Dingolfing-Landau

    There is the land of the sharars?, Germany,

    RECRUITING

    Germany,

    Asthma Allergy Center

    Leverkusen, Germany,

    RECRUITING

    Germany,

    Pulmonary Clinic Medical Clinic I, Pulmonology

    Löwenstein, Germany,

    RECRUITING

    Germany,

    Ukf pneumologie gmbh & co. Kg

    Mainz, Germany,

    RECRUITING

    Germany,

    Lung specialist practice Dr. C. Lüttecke-Hecht

    Mainz, Germany,

    ACTIVE NOT RECRUITING

    Germany,

    Lung specialist practice Dr. Gall

    Mainz, Germany,

    RECRUITING

    Germany,

    Mainz University Medical Center

    Mainz, Germany,

    RECRUITING

    Germany,

    Dr. from Haunersches Children's Hospital

    München, Germany,

    RECRUITING

    Germany,

    LMU Hospital of the University of Munich, Outpatient Clinic for Severe Asthma (Adults)

    München, Germany,

    RECRUITING

    Germany,

    Regensburg University Hospital

    Regensburg, Germany,

    ACTIVE NOT RECRUITING

    Germany,

    University Medical Center Rostock, Medical Clinic I, Dept. Pulmonology & Interdisciplinary. Internal intensive care medicine

    Rostock, Germany,

    RECRUITING

    Germany,

    Pulmonary Practice Schleswig/ Respiratio

    Schleswig, Germany,

    RECRUITING

    Germany,

    Ambulant Pneumology with Allergy Sergetum (BAG)

    Stuttgart, Germany,

    RECRUITING

    Germany,

    RBK Lungenzentrum Stuttgart

    Stuttgart, Germany,

    RECRUITING

    Germany,

    Internal medicine group practice Bitburg-Trier

    Trier, Germany,

    RECRUITING

    Germany,

    Ulm University Hospital, Pulmonology Section, Department of Internal Medicine II

    Ulm, Germany,

    RECRUITING

    Germany,

    Specialist clinics Wangen

    cheeks, Germany,

    RECRUITING

    Germany,

    Marien Hospital, Clinic for Pediatric and Adolescent Medicine

    Wesel, Germany,