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Status:

RECRUITING

Register Schweres Asthma - German Asthma Net e.V.

Lead Sponsor:

German Asthma Net e.V.

Collaborating Sponsors:

AstraZeneca

GlaxoSmithKline

Conditions:

Severe Asthma

Eligibility:

All Genders

6+ years

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...

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 eosino...

Eligibility Criteria

Inclusion

  • 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:
  • Maintenance treatment with high doses of ICS (\>400 μg budesonide or equivalent / ≥ 200 μg of fluticasone as monotherapy) or
  • 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
  • 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:
  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2011

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    November 1 2026

    Estimated Enrollment :

    4500 Patients enrolled

    Trial Details

    Trial ID

    NCT06035289

    Start Date

    November 1 2011

    End Date

    November 1 2026

    Last Update

    October 2 2024

    Active Locations (45)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 12 (45 locations)

    1

    Kardiologische und fachinternistische ÜBAG Dr. Sandrock und Partner

    Altdorf, Germany

    2

    Universitätsklinikum Augsburg Kinderpulmologie und -allergologie

    Augsburg, Germany

    3

    Praxis Dr. Grün

    Bad Windsheim, Germany

    4

    CIMS Studienzentrum Bamberg

    Bamberg, Germany