Swiss Severe Asthma Register

NCT03984253 | Recruiting

• 1 other identifier: 2018-01553
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 10

Brief Summary

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

Severe Asthma

Keywords

Asthma; Severe; Register

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Exacerbations

  Baseline, four months, yearly for up to 15 years

• Utilization of the health care system

  Baseline, four months, yearly for up to 15 years

• Quality of Life Questionnaire

  Baseline, four months, yearly for up to 15 years

• Symptoms and health-related quality of life

  Baseline, four months, yearly for up to 15 years

• Changes in Medication

  Baseline, four months, yearly for up to 15 years

Study Arms (1)

Severe Asthma

All patients with severe asthma who will be treated in the participating centers should be continuously enrolled in the register.

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• In- and outpatients
• Age ≥ 0 year
• Informed consent as documented by signature
• Adults:
• "Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 asthma:
• High level therapy:
• high dose ICS with ≥ 1000 μg beclomethasone (powder) or equivalent in combination with LABA or leukotriene modifier/theophylline) for the previous year or
• Daily long-term therapy with systemic corticosteroids (CS) for ≥50% of the previous year to prevent it from becoming "uncontrolled" or which remains "uncontrolled" despite this therapy or
• Therapy with monoclonal antibodies independent from the co-therapy
• Middle level therapy:
• Protokollsynopsis SAR Version 01 16.01.2019 Seite 4/10 a) Daily long-term therapy with medium-to high-dose ICS (≥500 μg Beclomethason (powder) or equivalent in combination with LABA or leukotriene modifier/theophylline) for the previous year and uncontrolled asthma defined as at least one of the following:
• Poor symptom control: ACQ consistently \>1.5, ACT \<20 (or "not well controlled" by NAEPP/GINA guidelines).
• Frequent severe exacerbations: two or more bursts of systemic CS (\>3 days each) in the previous year.
• Serious exacerbations: at least one hospitalization, ICU stay or mechanical ventilation in the previous year.
• Airflow limitation: after appropriate bronchodilator withhold FEV1 \<80% predicted (in the face of reduced FEV1/FVC defined as less than the lower limit of normal).

You may not qualify if:

• Life-expectancy \<6 months
• Insufficient knowledge of project language
• Children:
• The criteria for severe or difficult asthma in children and adolescents are considered fulfilled in the case of insufficient symptom control in the last year despite medium/high antiinflammatory long-term therapy:
• diagnosis of bronchial asthma made by a physician
• differential diagnoses excluded
• good compliance and trained inhalation technique
• treatment with biological approved for the treatment of severe asthma (currently only omalizumab) or
• Proof of:
• a) Positive Bronchodilation-test (≥12% increase in FEV1 after SABA) or b) Significant bronchial hyperresponsiveness after nonspecific provocation (e.g., with Methacholine or treadmill) according to ATS criteria (AJRCCM 2000)
• High level of therapy:
• Prolonged therapy with high dose inhaled steroid (ICS) (\> 400 μg Budesonide equivalent /\> 200 μg fluticasone alone); or
• Daily long-term therapy with medium- to high-dose ICS (≥ 400 μg Budesonide equivalent / ≥200 μg fluticasone) in combination with long-acting betaagonists and / or leukotriene receptor antagonist and / or theophylline; or
• Therapy with oral steroids fixed ≥3 last months.
• Insufficient asthma control

Sponsors & Collaborators

• Prof. Dr. Jörg Leuppi: lead
• AstraZeneca: collaborator
• GlaxoSmithKline: collaborator
• Lungenliga Schweiz: collaborator
• Novartis: collaborator

Study Sites (10)

Cantonal Hospital Baselland Liestal

Liestal, Basel-Landschaft, 4410, Switzerland

RECRUITING

Universitätsklinik für Pneumologie, Inselspital

Bern, Switzerland

RECRUITING

Pneumologie, Kantonsspital Graubünden

Chur, Switzerland

RECRUITING

Klinik für Pneumologie, Hochgebirgsklinik Davos

Davos, Switzerland

RECRUITING

Hôpitaux Universitaires Genève

Geneva, Switzerland

RECRUITING

Centre hospitalier universitaire vaudoise

Lausanne, Switzerland

RECRUITING

Pneumologia, Ospedale Civico

Lugano, Switzerland

RECRUITING

Klinik für Pneumologie und Schlafmedizin, Kantonsspital St.Gallen

Sankt Gallen, Switzerland

RECRUITING

Hôpital du valais, sion

Sion, Switzerland

RECRUITING

Klinik für Pneumologie, Universitätsspital Zürich

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Asthma; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• Jörg Leuppi

  Kantonsspital Baselland Liestal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jörg Leuppi

CONTACT

+41619252181; Joerg.leuppi@ksbl.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: June 12, 2019
• Study Start: May 13, 2019
• Primary Completion (Estimated): February 28, 2034
• Study Completion (Estimated): February 28, 2034
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

CH (10)