Register Schweres Asthma - German Asthma Net e.V.

Recruiting

• Conditions: Severe Asthma

• Registration Number: NCT06035289
• Lead Sponsor: German Asthma Net e.V.

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.

Study Timeline

• Study Start: 2011-11-01
• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (45)

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

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

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