Actively Recruiting

Age: 1Year +
All Genders
NCT03984253

Swiss Severe Asthma Register

Led by Prof. Dr. Jörg Leuppi · Updated on 2025-03-12

600

Participants Needed

10

Research Sites

772 weeks

Total Duration

On this page

Sponsors

P

Prof. Dr. Jörg Leuppi

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

Asthma is one of the most common chronic diseases. Asthma is characterized by chronic airway inflammation and associated with airway hyperresponsiveness and reversible airflow obstruction. The variability of airway obstruction is triggered by different factors that lead to a variety of different asthma phenotypes and subtypes. The various classification options for asthma (e.g. severity, by the predominantly existing inflammation or according to triggers), reflect its heterogeneity. Despite improved therapeutic methods, the prevalence and morbidity of asthma has increased worldwide in the last years. Asthma is a serious and growing global health problem with around 300 million people affected, independent of age or sex. Estimated 250'000 people die prematurely each year due to their asthma. Based on the SAPALDIA-study, the prevalence of Asthma in Switzerland is approximately 2-8%. Asthma is considered as a major factor in healthcare cost with up to CHF 1.2 billion per year. Asthma is not only a financial burden to a system; it affects the individual Quality of life negatively. Often health care professionals and patients underestimate the severity of the disease and overestimate asthma control. Severe asthma should not be equated with uncontrolled asthma. To reach a satisfying asthma control numerous factors need to be taken into consideration. Severe asthma is often associated with a high risk of frequent, severe exacerbations, which can even lead to death. Several severe asthma cohorts and registries already exists and are reported in the literature. The aim of such registries is in general data collection and a better understanding of the disease. So far, most epidemiological studies on severe asthma are cross-sectional with no follow up measures. Only a few studies did repeated measures using the same methods. Approximately 5% of all Asthma Patients suffers from severe asthma. These patients require systematic assessment and specialist care in dedicated respiratory centres. These centres have a key role in improving the outcome for severe asthma patients. At the same time they act as gatekeepers to ensure appropriate access to new, expensive therapies, this includes antibody treatment and interventional methods such as thermoplasty. These treatments require careful monitoring. It is important to ensure that they are given to the right population. Special assessment to monitor the efficacy and to prevent inappropriate prescribing, exposure of patients to unnecessary risks and excessive costs is indicated. For all the mentioned reasons a Swiss Severe Asthma Register and a collaboration with an already existing register is needed to prospectively collect data about severe asthma in Switzerland.

CONDITIONS

Official Title

Swiss Severe Asthma Register

Who Can Participate

Age: 1Year +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients can be inpatients or outpatients
  • Age 0 years or older
  • Signed informed consent
  • Adults with asthma requiring high-level therapy (high-dose ICS with LABA or leukotriene modifier/theophylline) for the previous year, or daily long-term systemic corticosteroids for at least 50% of the previous year, or monoclonal antibody therapy
  • Adults on medium-level therapy with medium to high-dose ICS plus other asthma medications with uncontrolled asthma defined by poor symptom control, frequent severe exacerbations, hospitalization, airflow limitation, or worsening on tapering therapy
  • Children and adolescents aged 0-18 years with physician-diagnosed bronchial asthma and insufficient symptom control despite medium/high anti-inflammatory long-term therapy
  • Children treated with approved biological therapy or with positive bronchodilation test or significant bronchial hyperresponsiveness
  • Children on prolonged high-dose inhaled steroids or medium to high-dose ICS in combination with other asthma medications or oral steroids for at least 3 months
  • Children with insufficient asthma control including symptoms at least 3 times weekly, activity limitation, night symptoms, or exacerbations requiring systemic steroids or inpatient treatment
  • Children with limited lung function at inclusion
  • Written consent from parent or legal guardian
Not Eligible

You will not qualify if you...

  • Life expectancy less than 6 months
  • Insufficient knowledge of the project language

AI-Screening

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Trial Site Locations

Total: 10 locations

1

Cantonal Hospital Baselland Liestal

Liestal, Basel-Landschaft, Switzerland, 4410

Actively Recruiting

2

Universitätsklinik für Pneumologie, Inselspital

Bern, Switzerland

Actively Recruiting

3

Pneumologie, Kantonsspital Graubünden

Chur, Switzerland

Actively Recruiting

4

Klinik für Pneumologie, Hochgebirgsklinik Davos

Davos, Switzerland

Actively Recruiting

5

Hôpitaux Universitaires Genève

Geneva, Switzerland

Actively Recruiting

6

Centre hospitalier universitaire vaudoise

Lausanne, Switzerland

Actively Recruiting

7

Pneumologia, Ospedale Civico

Lugano, Switzerland

Actively Recruiting

8

Klinik für Pneumologie und Schlafmedizin, Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Actively Recruiting

9

Hôpital du valais, sion

Sion, Switzerland

Actively Recruiting

10

Klinik für Pneumologie, Universitätsspital Zürich

Zurich, Switzerland

Actively Recruiting

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Research Team

J

Jörg Leuppi

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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