Clinical trial NCT06035289: Register Schweres Asthma - German Asthma Net e.V.
Official title: Klinisches Register Schweres Asthma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Asthma
Keywords: Registry
Biological
Lead sponsor: German Asthma Net e.V.
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: GlaxoSmithKline
name: Sanofi
name: Chiesi Farmaceutici S.p.A.
First posted: 2023-09-13
Enrollment: 4500
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to participating study center (pulmonologists in private practice or in pulmonary departments in hospital)

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.

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:

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

Primary outcomes:
measure: Symptom Control
timeFrame: Baseline, four months, yearly for up to 15 years
Secondary outcomes:
measure: Exacerbations
timeFrame: Baseline, four months, yearly for up to 15 years
measure: Utilization of the health care system
timeFrame: Baseline, yearly for up to 15 years
measure: Symptoms and health-related quality of life
timeFrame: Baseline, yearly for up to 15 years
measure: Quality of Life Questionnaire
timeFrame: Baseline, yearly for up to 15 years
measure: Asthma Control Questionnaire
timeFrame: Baseline, yearly for up to 15 years
measure: Forced Exhaled Volume in 1 second (FEV1)
timeFrame: Baseline, 4 months, yearly for up to 15 years
measure: Forced Vital Capacity (FVC)
timeFrame: Baseline, 4 months, yearly for up to 15 years
measure: Changes in medication
timeFrame: Baseline, 4 months, yearly for up to 15 years
measure: Changes in dose in mg
timeFrame: 4 months, yearly for up to 15 years
measure: Fraction of exhaled nitric oxide (FeNo)
timeFrame: Baseline, 4 months, yearly for up to 15 years
measure: Blood Gas analysis
timeFrame: Baseline, 4 months, yearly for up to 15 years
measure: Blood Gas analysis
timeFrame: Baseline, 4 months, yearly for up to 15 years
measure: Leucocytes
timeFrame: Baseline, 4 months, yearly for up to 15 years
measure: Neutrophilic granulocytes
timeFrame: Baseline, 4 months, yearly for up to 15 years
measure: Eosinophilic granulocytes
timeFrame: Baseline, 4 months, yearly for up to 15 years
measure: CO diffusion capacity
timeFrame: Baseline, yearly for up to 15 years
Other outcomes:
Locations:
city: Altdorf
country: Germany
facility: Kardiologische und fachinternistische ÜBAG Dr. Sandrock und Partner
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg Kinderpulmologie und -allergologie
city: Bad Windsheim
country: Germany
facility: Praxis Dr. Grün
city: Bamberg
country: Germany
facility: CIMS Studienzentrum Bamberg
city: Berlin
country: Germany
facility: Lungenpraxis Tegel
city: Bielefeld
country: Germany
facility: Evangelisches Klinikum Bethel v. Bodelschwinghsche Stiftungen Bethel
city: Bonn
country: Germany
facility: Helios Lungen- und Allergiezentrum Bonn
city: Bonn
country: Germany
facility: Universitätsnedizin Bonn
city: Bonn
country: Germany
facility: Zentrum für Kinderheilkunde, Klinik und Poliklinik für Allgemeine Pädiatrie, Allergieabteilung
city: Bremen
country: Germany
facility: Prof.-Hess-Kinderklinik Bremen-Mitte
city: Böblingen
country: Germany
facility: Lungenpraxis Medicum Böblingen
city: Cottbus
country: Germany
facility: MECS Cottbus
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
city: Erlangen
country: Germany
facility: Lunge im Zentrum
city: Essen
country: Germany
facility: Universitätsmedizin Essen
city: Esslingen
country: Germany
facility: Pneumologie am Schelztor Esslingen
city: Freising
country: Germany
facility: Praxis Dr. Herden
city: Göppingen
country: Germany
facility: ALB FILS Kliniken
city: Hamburg
country: Germany
facility: Hamburger Institut für Therapieforschung GmbH
city: Hanover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Praxisgmeinschaft Dr. Abenhardt und Jochen Hinrichs-Pavlik
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
city: Heilbronn
country: Germany
facility: Lungenarztpraxis Dr. Hubatsch
city: Kaiserslautern
country: Germany
facility: Atemwegszentrum Kaiserslautern
city: Kempten
country: Germany
facility: MVZ Klinikum Kempten
city: Koblenz
country: Germany
facility: Pneumologische Gemeinschaftspraxis
city: Konstanz
country: Germany
facility: Lungenpraxis Konstanz
city: Landau an der Isar
country: Germany
facility: DONAUISAR Klinikum Deggendorf-Dingolfing-Landau
city: Leverkusen
country: Germany
facility: Asthma Allergiezentrum
city: Löwenstein
country: Germany
facility: Lungenfachklinik Medizinische Klinik I, Pneumologie
city: Mainz
country: Germany
facility: IKF Pneumologie GmbH & Co. KG
city: Mainz
country: Germany
facility: Lungenfacharztpraxis Dr. C. Lüttecke-Hecht
city: Mainz
country: Germany
facility: Lungenfacharztpraxis Dr. Gall
city: Mainz
country: Germany
facility: Univsersitätsmedizin Mainz
city: München
country: Germany
facility: Dr. von Haunersches Kinderspital
city: München
country: Germany
facility: LMU Klinikum der Universität München, Ambulanz für Schweres Asthma (Erwachsene)
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock, Med. Klinik I, Abt. Pneumologie & Interdiszipl. Internistische Intensivmedizin
city: Schleswig
country: Germany
facility: Lungenpraxis Schleswig/ Respiratio
city: Stuttgart
country: Germany
facility: Ambulante Pneumologie mit Allergiezentrum (BAG)
city: Stuttgart
country: Germany
facility: RBK Lungenzentrum Stuttgart
city: Trier
country: Germany
facility: Internistische Gemeinschaftspraxis Bitburg-Trier
city: Ulm
country: Germany
facility: Uniklinik Ulm, Sektion Pneumologie, Klinik für Innere Medizin II
city: Wangen Im Allgäu
country: Germany
facility: Fachkliniken Wangen
city: Wesel
country: Germany
facility: Marien-Hospital, Klinik für Kinder- und Jugendmedizin
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.