Register Schweres Asthma - German Asthma Net e.V.

Official title

Klinisches Register Schweres Asthma

Overview

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.

Primary outcome measures

• Symptom Control [Time frame: Baseline, four months, yearly for up to 15 years]

Secondary outcome measures (12)

• Exacerbations [Time frame: Baseline, four months, yearly for up to 15 years]
• Utilization of the health care system [Time frame: Baseline, yearly for up to 15 years]
• Symptoms and health-related quality of life [Time frame: Baseline, yearly for up to 15 years]
• Quality of Life Questionnaire [Time frame: Baseline, yearly for up to 15 years]
• Asthma Control Questionnaire [Time frame: Baseline, yearly for up to 15 years]
• Forced Exhaled Volume in 1 second (FEV1) [Time frame: Baseline, 4 months, yearly for up to 15 years]
• Forced Vital Capacity (FVC) [Time frame: Baseline, 4 months, yearly for up to 15 years]
• Changes in medication [Time frame: Baseline, 4 months, yearly for up to 15 years]
• Changes in dose in mg [Time frame: 4 months, yearly for up to 15 years]
• Fraction of exhaled nitric oxide (FeNo) [Time frame: Baseline, 4 months, yearly for up to 15 years]
• Blood Gas analysis [Time frame: Baseline, 4 months, yearly for up to 15 years]
• Blood Gas analysis [Time frame: Baseline, 4 months, yearly for up to 15 years]

Eligibility 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:

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 45 centers

• Kardiologische und fachinternistische ÜBAG Dr. Sandrock und Partner — Altdorf
• Universitätsklinikum Augsburg Kinderpulmologie und -allergologie — Augsburg
• Praxis Dr. Grün — Bad Windsheim
• CIMS Studienzentrum Bamberg — Bamberg
• Lungenpraxis Tegel — Berlin
• Evangelisches Klinikum Bethel v. Bodelschwinghsche Stiftungen Bethel — Bielefeld
• Helios Lungen- und Allergiezentrum Bonn — Bonn
• Universitätsnedizin Bonn — Bonn
• … and 37 more centers

Publications

• Bal C, Pohl W, Milger K, Skowasch D, Schulz C, Gappa M, Koerner-Rettberg C, Jandl M, Schmidt O, Zehetmayer S, Taube C, Hamelmann E, Buhl R, Korn S, Idzko M; German Asthma Net (GAN) study group. Characterization of Obesity in Severe Asthma in the German Asthma Net. J Allergy Clin Immunol Pract. 2023 Nov;11(11):3417-3424.e3. doi: 10.1016/j.jaip.2023.06.049. Epub 2023 Jul 4. PMID 37406803
• Milger K, Suhling H, Skowasch D, Holtdirk A, Kneidinger N, Behr J, Timmermann H, Schulz C, Schmidt O, Ehmann R, Hamelmann E, Idzko M, Taube C, Lommatzsch M, Buhl R, Korn S. Response to Biologics and Clinical Remission in the Adult German Asthma Net Severe Asthma Registry Cohort. J Allergy Clin Immunol Pract. 2023 Sep;11(9):2701-2712.e2. doi: 10.1016/j.jaip.2023.05.047. Epub 2023 Jun 8. PMID 37301433
• Korn S, Milger K, Skowasch D, Schulz C, Mohrlang C, Wernitz M, Paulsson T, Hennig M, Buhl R. Real-World Experience on the Use of Mepolizumab from the Severe Asthma Registry of the German Asthma Net (MepoGAN-Study). J Asthma Allergy. 2023 May 11;16:541-552. doi: 10.2147/JAA.S403286. eCollection 2023. PMID 37197193
• Milger K, Skowasch D, Hamelmann E, Mummler C, Idzko M, Gappa M, Jandl M, Korner-Rettberg C, Ehmann R, Schmidt O, Taube C, Holtdirk A, Timmermann H, Buhl R, Korn S. Bronchodilator Reversibility in the GAN Severe Asthma Cohort. J Investig Allergol Clin Immunol. 2023 Dec 14;33(6):446-456. doi: 10.18176/jiaci.0850. Epub 2022 Aug 24. PMID 36000830
• Bal C, Idzko M, Skrgat S, Koch A, Milger K, Schulz C, Zehetmayer S, Hamelmann E, Buhl R, Korn S; collaborators from the German Asthma Net (GAN). Fraction of exhaled nitric oxide is associated with disease burden in the German Asthma Net severe asthma cohort. Eur Respir J. 2022 Jun 2;59(6):2101233. doi: 10.1183/13993003.01233-2021. Print 2022 Jun. PMID 35273030

Identifiers

NCT: NCT06035289 · 2018-13614

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗