Register Schweres Asthma - German Asthma Net e.V.

September 12, 2023 updated by: German Asthma Net e.V.

Klinisches Register Schweres Asthma

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

4500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Altdorf, Germany
        • Recruiting
        • Kardiologische und fachinternistische ÜBAG Dr. Sandrock und Partner
        • Contact:
          • Markus Gasplmayr
      • Augsburg, Germany
        • Active, not recruiting
        • Universitätsklinikum Augsburg Kinderpulmologie und -allergologie
      • Bad Windsheim, Germany
        • Recruiting
        • Praxis Dr. Grün
        • Contact:
          • Borghild Grün, Dr.
      • Bamberg, Germany
        • Recruiting
        • CIMS Studienzentrum Bamberg
        • Contact:
          • Joachim Kirschner, Dr.
      • Berlin, Germany
        • Recruiting
        • Lungenpraxis Tegel
        • Contact:
          • Thomas Hering
      • Bielefeld, Germany
        • Recruiting
        • Evangelisches Klinikum Bethel v. Bodelschwinghsche Stiftungen Bethel
        • Contact:
          • Eckard Hamelmann, Prof.
      • Bonn, Germany
        • Recruiting
        • Helios Lungen- und Allergiezentrum Bonn
        • Contact:
          • Marcus Joest
      • Bonn, Germany
        • Recruiting
        • Universitätsnedizin Bonn
        • Contact:
          • Dirk Skowasch, Prof.
      • Bonn, Germany
        • Active, not recruiting
        • Zentrum für Kinderheilkunde, Klinik und Poliklinik für Allgemeine Pädiatrie, Allergieabteilung
      • Bremen, Germany
        • Recruiting
        • Prof.-Hess-Kinderklinik Bremen-Mitte
        • Contact:
          • Petra Kaiser-Labusch
      • Böblingen, Germany
        • Recruiting
        • Lungenpraxis Medicum Böblingen
        • Contact:
          • Stefan Veitshans, Dr.
      • Cottbus, Germany
        • Recruiting
        • MECS Cottbus
        • Contact:
          • Frank Käßner, Dr.
      • Düsseldorf, Germany
        • Recruiting
        • Evangelisches Krankenhaus Düsseldorf
        • Contact:
          • Monika Gappa, Prof.
      • Erlangen, Germany
        • Recruiting
        • Lunge im Zentrum
        • Contact:
          • Sabine Lampert, Dr.
      • Essen, Germany
        • Active, not recruiting
        • Universitätsmedizin Essen
      • Esslingen, Germany
        • Recruiting
        • Pneumologie am Schelztor Esslingen
        • Contact:
          • Silke Hellmich, Dr.
      • Freising, Germany
        • Recruiting
        • Praxis Dr. Herden
        • Contact:
          • Markus Herden, Dr.
      • Göppingen, Germany
        • Recruiting
        • ALB FILS Kliniken
        • Contact:
          • Timo Deininger, Dr.
      • Hamburg, Germany
        • Recruiting
        • Hamburger Institut für Therapieforschung GmbH
        • Contact:
          • Margret Jandl, Dr.
      • Hanover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Hendrik Suhling, PD Dr.
      • Heidelberg, Germany
        • Recruiting
        • Praxisgmeinschaft Dr. Abenhardt und Jochen Hinrichs-Pavlik
        • Contact:
          • Birgit Abenhardt, Dr.
      • Heidelberg, Germany
        • Recruiting
        • Thoraxklinik Heidelberg gGmbH
        • Contact:
          • Felix Herdt, Prof.
      • Heilbronn, Germany
        • Active, not recruiting
        • Lungenarztpraxis Dr. Hubatsch
      • Kaiserslautern, Germany
        • Recruiting
        • Atemwegszentrum Kaiserslautern
        • Contact:
          • Florian Schmitz, Dr.
      • Kempten, Germany
        • Recruiting
        • MVZ Klinikum Kempten
        • Contact:
          • Kim Husemann, Dr.
      • Koblenz, Germany
        • Recruiting
        • Pneumologische Gemeinschaftspraxis
        • Contact:
          • Olaf Schmidt, Dr.
      • Konstanz, Germany
        • Active, not recruiting
        • Lungenpraxis Konstanz
      • Landau an der Isar, Germany
        • Recruiting
        • DONAUISAR Klinikum Deggendorf-Dingolfing-Landau
        • Contact:
          • Christian Geltner, Dr.
      • Leverkusen, Germany
        • Recruiting
        • Asthma Allergiezentrum
        • Contact:
          • Norbert Mülleneisen
      • Löwenstein, Germany
        • Recruiting
        • Lungenfachklinik Medizinische Klinik I, Pneumologie
        • Contact:
          • Monika Stephan, Dr.
      • Mainz, Germany
        • Recruiting
        • IKF Pneumologie GmbH & Co. KG
        • Contact:
          • Stephanie Korn, Prof.
      • Mainz, Germany
        • Recruiting
        • Lungenfacharztpraxis Dr. C. Lüttecke-Hecht
        • Contact:
          • Camilla Lüttecke-Hecht, Dr.
      • Mainz, Germany
        • Active, not recruiting
        • Lungenfacharztpraxis Dr. Gall
      • Mainz, Germany
        • Recruiting
        • Univsersitätsmedizin Mainz
        • Contact:
          • Roland Buhl, Prof.
      • München, Germany
        • Recruiting
        • Dr. Von Haunersches Kinderspital
        • Contact:
          • Bianca Schaub, Prof.
      • München, Germany
        • Recruiting
        • LMU Klinikum der Universität München, Ambulanz für Schweres Asthma (Erwachsene)
        • Contact:
          • Katrin Milger-Kneidinger, PD Dr.
      • Regensburg, Germany
        • Recruiting
        • Universitätsklinikum Regensburg
        • Contact:
          • Christian Schulz, Prof.
      • Rostock, Germany
        • Active, not recruiting
        • Universitätsmedizin Rostock, Med. Klinik I, Abt. Pneumologie & Interdiszipl. Internistische Intensivmedizin
      • Schleswig, Germany
        • Recruiting
        • Lungenpraxis Schleswig/ Respiratio
        • Contact:
          • Andreas Deimling, Dr.
      • Stuttgart, Germany
        • Recruiting
        • Ambulante Pneumologie mit Allergiezentrum (BAG)
        • Contact:
          • Rainer Ehmann
      • Stuttgart, Germany
        • Recruiting
        • RBK Lungenzentrum Stuttgart
        • Contact:
          • Claus Neurohr, Dr.
      • Trier, Germany
        • Recruiting
        • Internistische Gemeinschaftspraxis Bitburg-Trier
        • Contact:
          • Patrick Albrecht, Dr.
      • Ulm, Germany
        • Recruiting
        • Uniklinik Ulm, Sektion Pneumologie, Klinik für Innere Medizin II
        • Contact:
          • Cornelia Kropf-Sanchen
      • Wangen Im Allgäu, Germany
        • Recruiting
        • Fachkliniken Wangen
        • Contact:
          • Susanne Hirschmann
      • Wesel, Germany
        • Recruiting
        • Marien-Hospital, Klinik für Kinder- und Jugendmedizin
        • Contact:
          • Cordula Körner-Rettberg, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to participating study center (pulmonologists in private practice or in pulmonary departments in hospital)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Control
Time Frame: 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).
Baseline, four months, yearly for up to 15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exacerbations
Time Frame: Baseline, four months, yearly for up to 15 years
Number of exacerbation with/without hospitalization
Baseline, four months, yearly for up to 15 years
Utilization of the health care system
Time Frame: 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
Baseline, yearly for up to 15 years
Symptoms and health-related quality of life
Time Frame: 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)
Baseline, yearly for up to 15 years
Quality of Life Questionnaire
Time Frame: 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)
Baseline, yearly for up to 15 years
Asthma Control Questionnaire
Time Frame: 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)
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
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)
Time Frame: 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
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 substances if there is a new drug used.
Baseline, 4 months, yearly for up to 15 years
Changes in dose in mg
Time Frame: 4 months, yearly for up to 15 years
Changes in dose in mg
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
Changes in FeNo in ppb
Baseline, 4 months, yearly for up to 15 years
Blood Gas analysis
Time Frame: Baseline, 4 months, yearly for up to 15 years
pO2 in kPa/ mmHg, pCO2 in kPa/ mmHg
Baseline, 4 months, yearly for up to 15 years
Blood Gas analysis
Time Frame: Baseline, 4 months, yearly for up to 15 years
Blood-oxygen saturation in %
Baseline, 4 months, yearly for up to 15 years
Leucocytes
Time Frame: Baseline, 4 months, yearly for up to 15 years
Changes in leucocytes in nl
Baseline, 4 months, yearly for up to 15 years
Neutrophilic granulocytes
Time Frame: Baseline, 4 months, yearly for up to 15 years
Changes in Neutrophilic granulocytes in nl or %
Baseline, 4 months, yearly for up to 15 years
Eosinophilic granulocytes
Time Frame: Baseline, 4 months, yearly for up to 15 years
Changes in Eosinophilic granulocytes in µl or %
Baseline, 4 months, yearly for up to 15 years
CO diffusion capacity
Time Frame: Baseline, yearly for up to 15 years
Changes in mmol/min/kPa/ %
Baseline, yearly for up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2011

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Severe Asthma

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