Severe Asthma
Conditions
Keywords
Registry, Biological
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.
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.
Interventions
None listed
Sponsors
AstraZeneca
GlaxoSmithKline
Sanofi
Chiesi Farmaceutici S.p.A.
German Asthma Net e.V.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Control | Baseline, four months, yearly for up to 15 years | Changes in symptom control at baseline and during the follow-up period and at study end using the Asthma Control Test (ACT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Utilization of the health care system | Baseline, yearly for up to 15 years | Number of visits at a pneumologist/ specialist, number of emergency consultations, number of hospitalizations, number of rehabilitation stays |
| Symptoms and health-related quality of life | Baseline, yearly for up to 15 years | Asthma Control Test (ACT: 5 questions, scale 1- 5, min score 5, max score 25, the lower the score the better the Asthma control) |
| Quality of Life Questionnaire | Baseline, yearly for up to 15 years | 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) |
| Asthma Control Questionnaire | Baseline, yearly for up to 15 years | 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) |
| Forced Exhaled Volume in 1 second (FEV1) | Baseline, 4 months, yearly for up to 15 years | FEV1 at consultation, FEV1 last 2 years, changes in FEV1 in liter from the target value |
| Forced Vital Capacity (FVC) | Baseline, 4 months, yearly for up to 15 years | FVC at consultation, FEV1 last 2 years, changes in FEV1 in liter from the target value |
| Changes in medication | Baseline, 4 months, yearly for up to 15 years | changes in substances if there is a new drug used. |
| Exacerbations | Baseline, four months, yearly for up to 15 years | Number of exacerbation with/without hospitalization |
| Fraction of exhaled nitric oxide (FeNo) | Baseline, 4 months, yearly for up to 15 years | Changes in FeNo in ppb |
| Blood Gas analysis | Baseline, 4 months, yearly for up to 15 years | pO2 in kPa/ mmHg, pCO2 in kPa/ mmHg |
| Leucocytes | Baseline, 4 months, yearly for up to 15 years | Changes in leucocytes in nl |
| Neutrophilic granulocytes | Baseline, 4 months, yearly for up to 15 years | Changes in Neutrophilic granulocytes in nl or % |
| Eosinophilic granulocytes | Baseline, 4 months, yearly for up to 15 years | Changes in Eosinophilic granulocytes in µl or % |
| CO diffusion capacity | Baseline, yearly for up to 15 years | Changes in mmol/min/kPa/ % |
| Changes in dose in mg | 4 months, yearly for up to 15 years | Changes in dose in mg |
Countries
Germany
Contacts
Primary ContactStephanie Korn, Prof.
Backup ContactMandy Seefeldt
Outcome results
None listed