Swiss Severe Asthma Register

ConditionSevere Asthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorProf. Dr. Jörg Leuppi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

In- and outpatients

Age ≥ 0 year

Informed consent as documented by signature

high dose ICS with ≥ 1000 μg beclomethasone (powder) or equivalent in combination with LABA or leukotriene modifier/theophylline) for the previous year or

Disqualifiers

Life-expectancy <6 months

Insufficient knowledge of project language

age 0-18 years, at time of inclusion

diagnosis of bronchial asthma made by a physician

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 1 trial group
Group A: Severe Asthma

Trial outcomes

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).

Time frame
Baseline, four months, yearly for up to 15 years

Secondary outcomes

1

Exacerbations

Number of exacerbation with/without hospitalization

Time frame
Baseline, four months, yearly for up to 15 years
2

Utilization of the health care system

Number of Visits at one's general practitioner (GP) Number of Visits at a pneumologist/ specialist Number of emergency consultations Number of hospitalizations Number of rehabilitation stays

Time frame
Baseline, four months, yearly for up to 15 years
3

Quality of Life Questionnaire

Mini Asthma Quality of Life Questionnaire(Mini-AQLQ) * 15 Questions, Scale 1 to 7 , Minimum Score 15, Maximum Score 105. * The higher the Score is, the better the quality of life

Time frame
Baseline, four months, yearly for up to 15 years
4

Symptoms and health-related quality of life

Asthma Control Test 5 Questions, Scale 1- 5, Minimum score 5, max 25, the smaller the score the better is the Asthma control

Time frame
Baseline, four months, yearly for up to 15 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prof. Dr. Jörg Leuppi

Lead sponsor

Cantonal Hosptal, Baselland

Sponsor institution

AstraZeneca

Collaborator

GlaxoSmithKline

Collaborator

Lungenliga Schweiz

Collaborator

Novartis

Collaborator