An observational study in Severe Asthma, sponsored by German Asthma Net e.V.. Recruiting at 45 sites in Germany. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by German Asthma Net e.V. · Observational
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 4,500 is above the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →This is the only study on the registry with German Asthma Net e.V. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients presenting to participating study center (pulmonologists in private practice or in pulmonary departments in hospital)
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:
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:
B) Medium level of treatment 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
Symptom Control
Changes in symptom control at baseline and during the follow-up period and at study end using the Asthma Control Test (ACT).
Time frame: Baseline, four months, yearly for up to 15 years
Exacerbations
Number of exacerbation with/without hospitalization
Time frame: Baseline, four months, yearly for up to 15 years
Utilization of the health care system
Number of visits at a pneumologist/ specialist, number of emergency consultations, number of hospitalizations, number of rehabilitation stays
Time frame: Baseline, yearly for up to 15 years
Symptoms and health-related quality of life
Asthma Control Test (ACT: 5 questions, scale 1- 5, min score 5, max score 25, the lower the score the better the Asthma control)
Time frame: Baseline, yearly for up to 15 years
Quality of Life Questionnaire
Mini Asthma Quality of Life Questionnaire (Mini-AQLQ: 15 questions, scale 1 to 7, min score 15, max score 105, the higher the score, the better the quality of life)
Time frame: Baseline, yearly for up to 15 years
Asthma Control Questionnaire
Asthma Control Questionnaire ACQ: 5 questions, scale 0 to 6, min score 0, max score 30, the lower the score the better the Asthma control)
Time frame: Baseline, yearly for up to 15 years
Forced Exhaled Volume in 1 second (FEV1)
FEV1 at consultation, FEV1 last 2 years, changes in FEV1 in liter from the target value
Time frame: Baseline, 4 months, yearly for up to 15 years
Forced Vital Capacity (FVC)
FVC at consultation, FEV1 last 2 years, changes in FEV1 in liter from the target value
Time frame: Baseline, 4 months, yearly for up to 15 years
Changes in medication
changes in substances if there is a new drug used.
Time frame: Baseline, 4 months, yearly for up to 15 years
Changes in dose in mg
Changes in dose in mg
Time frame: 4 months, yearly for up to 15 years
Fraction of exhaled nitric oxide (FeNo)
Changes in FeNo in ppb
Time frame: Baseline, 4 months, yearly for up to 15 years
Blood Gas analysis
pO2 in kPa/ mmHg, pCO2 in kPa/ mmHg
Time frame: Baseline, 4 months, yearly for up to 15 years
Blood Gas analysis
Blood-oxygen saturation in %
Time frame: Baseline, 4 months, yearly for up to 15 years
Leucocytes
Changes in leucocytes in nl
Time frame: Baseline, 4 months, yearly for up to 15 years
Neutrophilic granulocytes
Changes in Neutrophilic granulocytes in nl or %
Time frame: Baseline, 4 months, yearly for up to 15 years
Eosinophilic granulocytes
Changes in Eosinophilic granulocytes in µl or %
Time frame: Baseline, 4 months, yearly for up to 15 years
CO diffusion capacity
Changes in mmol/min/kPa/ %
Time frame: Baseline, yearly for up to 15 years
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