Register Schweres Asthma - German Asthma Net e.V.

Severe Asthma Clinical Trial

Official title:

Klinisches Register Schweres Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035289
• Other study ID #: 2018-13614
• Status: Recruiting
• Start date: November 1, 2011
• Est. completion date: November 1, 2026

Study information

• Verified date: September 2023
• Source: German Asthma Net e.V.
• Contact: Stephanie Korn, Prof.
• Phone: +49 (0)1577-6948673
• Email: info[@]german-asthma-net.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Locations

Country	Name	City	State
Germany	Kardiologische und fachinternistische ÜBAG Dr. Sandrock und Partner	Altdorf
Germany	Universitätsklinikum Augsburg Kinderpulmologie und -allergologie	Augsburg
Germany	Praxis Dr. Grün	Bad Windsheim
Germany	CIMS Studienzentrum Bamberg	Bamberg
Germany	Lungenpraxis Tegel	Berlin
Germany	Evangelisches Klinikum Bethel v. Bodelschwinghsche Stiftungen Bethel	Bielefeld
Germany	Lungenpraxis Medicum Böblingen	Böblingen
Germany	Helios Lungen- und Allergiezentrum Bonn	Bonn
Germany	Universitätsnedizin Bonn	Bonn
Germany	Zentrum für Kinderheilkunde, Klinik und Poliklinik für Allgemeine Pädiatrie, Allergieabteilung	Bonn
Germany	Prof.-Hess-Kinderklinik Bremen-Mitte	Bremen
Germany	MECS Cottbus	Cottbus
Germany	Evangelisches Krankenhaus Düsseldorf	Düsseldorf
Germany	Lunge im Zentrum	Erlangen
Germany	Universitätsmedizin Essen	Essen
Germany	Pneumologie am Schelztor Esslingen	Esslingen
Germany	Praxis Dr. Herden	Freising
Germany	ALB FILS Kliniken	Göppingen
Germany	Hamburger Institut für Therapieforschung GmbH	Hamburg
Germany	Medizinische Hochschule Hannover	Hanover
Germany	Praxisgmeinschaft Dr. Abenhardt und Jochen Hinrichs-Pavlik	Heidelberg
Germany	Thoraxklinik Heidelberg gGmbH	Heidelberg
Germany	Lungenarztpraxis Dr. Hubatsch	Heilbronn
Germany	Atemwegszentrum Kaiserslautern	Kaiserslautern
Germany	MVZ Klinikum Kempten	Kempten
Germany	Pneumologische Gemeinschaftspraxis	Koblenz
Germany	Lungenpraxis Konstanz	Konstanz
Germany	DONAUISAR Klinikum Deggendorf-Dingolfing-Landau	Landau an der Isar
Germany	Asthma Allergiezentrum	Leverkusen
Germany	Lungenfachklinik Medizinische Klinik I, Pneumologie	Löwenstein
Germany	IKF Pneumologie GmbH & Co. KG	Mainz
Germany	Lungenfacharztpraxis Dr. C. Lüttecke-Hecht	Mainz
Germany	Lungenfacharztpraxis Dr. Gall	Mainz
Germany	Univsersitätsmedizin Mainz	Mainz
Germany	Dr. von Haunersches Kinderspital	München
Germany	LMU Klinikum der Universität München, Ambulanz für Schweres Asthma (Erwachsene)	München
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Universitätsmedizin Rostock, Med. Klinik I, Abt. Pneumologie & Interdiszipl. Internistische Intensivmedizin	Rostock
Germany	Lungenpraxis Schleswig/ Respiratio	Schleswig
Germany	Ambulante Pneumologie mit Allergiezentrum (BAG)	Stuttgart
Germany	RBK Lungenzentrum Stuttgart	Stuttgart
Germany	Internistische Gemeinschaftspraxis Bitburg-Trier	Trier
Germany	Uniklinik Ulm, Sektion Pneumologie, Klinik für Innere Medizin II	Ulm
Germany	Fachkliniken Wangen	Wangen Im Allgäu
Germany	Marien-Hospital, Klinik für Kinder- und Jugendmedizin	Wesel

Sponsors (5)

Lead Sponsor	Collaborator
German Asthma Net e.V.	AstraZeneca, Chiesi Farmaceutici S.p.A., GlaxoSmithKline, Sanofi

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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 coho — View 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 As — View 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 — View 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 Immu — View 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 — View Citation

Outcome

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

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