Swiss Severe Asthma Register
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.
• 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).
• Controlled asthma that worsens on tapering of these high doses of ICS or systemic CS (or additional biologics). The presence of any one of the following exclusion criteria will lead to exclusion of the patients:
• 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:
• age 0-18 years, at time of inclusion
• 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
• a) Inadequate symptom control after NVL in the last 4 weeks: Protokollsynopsis SAR Version 01 16.01.2019 Seite 5/10
⁃ ≥3 x weekly asthma symptoms or use of ondemand medication; Or:
⁃ limited activity due to asthma; Or:
⁃ any symptoms at night; or b. Exacerbation(s) ≥1 last year that required treatment with systemic steroids and / or inpatient treatment c. limited lung function:
⁃ pathological Tiffeneau quotient or FEV1 at inclusion.
• Submission of a written consent (parent/ legal guardian).