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Registry for patients with severe asthma in Germany

Klinisches Register Schweres Asthma

Observational German Asthma Net e.V. · NCT06035289

This study is collecting health information from kids and teens with severe asthma to see how well their treatment is working and improve care for them over the next fifteen years.

Quick facts

Study typeObservational
Enrollment4500 (estimated)
Ages6 Years and up
SexAll
SponsorGerman Asthma Net e.V. Academic / other
Locations45 sites (Altdorf and 44 other locations)
Trial IDNCT06035289 on ClinicalTrials.gov

What this trial studies

The German Asthma Net e.V. focuses on optimizing medical care and treatment for patients with severe asthma through a comprehensive clinical registry. This observational study collects sociodemographic and medical parameters, including lung function and asthma control data, from participants aged 6-18 years who have poor symptom control despite high doses of maintenance treatment. Data will be collected at baseline and annually for fifteen years to better understand the incidence, prevalence, and treatment of severe asthma. The registry aims to enhance the diagnostic evaluation and treatment strategies by pooling data from multiple centers across Germany.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 6-18 years with severe asthma who have poor symptom control despite high doses of anti-inflammatory treatment.

Not a fit: Patients with well-controlled asthma or those not meeting the criteria for severe asthma may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could lead to improved treatment strategies and better management of severe asthma in patients.

How similar studies have performed: Other similar registries have shown success in improving understanding and management of chronic conditions, indicating potential for this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Altdorf and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Severe AsthmaRegistryBiological
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.