Register Schweres Asthma - German Asthma Net e.V.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Klinisches Register Schweres Asthma

Conditions
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Severe Asthma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Control | Changes in symptom control at baseline and during the follow-up period and at study end using the Asthma Control Test (ACT). | Baseline, four months, yearly for up to 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbations | Number of exacerbation with/without hospitalization | 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 | 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) | 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) | 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) | 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 | 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 | Baseline, 4 months, yearly for up to 15 years | 
| Changes in medication | changes in substances if there is a new drug used. | Baseline, 4 months, yearly for up to 15 years | 
| Changes in dose in mg | Changes in dose in mg | 4 months, yearly for up to 15 years | 
| Fraction of exhaled nitric oxide (FeNo) | Changes in FeNo in ppb | Baseline, 4 months, yearly for up to 15 years | 
| Blood Gas analysis | pO2 in kPa/ mmHg, pCO2 in kPa/ mmHg | Baseline, 4 months, yearly for up to 15 years | 
| Blood Gas analysis | Blood-oxygen saturation in % | Baseline, 4 months, yearly for up to 15 years | 
| Leucocytes | Changes in leucocytes in nl | Baseline, 4 months, yearly for up to 15 years | 
| Neutrophilic granulocytes | Changes in Neutrophilic granulocytes in nl or % | Baseline, 4 months, yearly for up to 15 years | 
| Eosinophilic granulocytes | Changes in Eosinophilic granulocytes in µl or % | Baseline, 4 months, yearly for up to 15 years | 
| CO diffusion capacity | Changes in mmol/min/kPa/ % | Baseline, yearly for up to 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registry, Biological