Register for patients with severe asthma

Swiss Severe Asthma Register

This study is creating a registry for people with severe asthma in Switzerland to collect important information that can help improve their treatment and care over the next 15 years.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 1 Year and up
• Sex: All
• Sponsor: Cantonal Hosptal, Baselland (other)
• Drugs / interventions: omalizumab
• Locations: 10 sites (Liestal, Basel-Landschaft and 9 other locations)
• Trial ID: NCT03984253 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish a clinical register for patients suffering from severe asthma across multiple centers in Switzerland. By collecting comprehensive data on the frequency, phenotype, and treatment of severe asthma, the study seeks to optimize diagnostic evaluations and therapeutic approaches. Patients will be followed for up to 15 years, with regular assessments of their asthma control using the Asthma Control Test (ACT) and other relevant parameters. The study addresses the significant gap in reliable information regarding severe asthma management.

Who should consider this trial

Good fit: Ideal candidates include patients of any age with severe asthma requiring high-level therapy as per GINA guidelines.

Not a fit: Patients with mild or well-controlled asthma may not receive any benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of severe asthma, ultimately enhancing patient outcomes.

How similar studies have performed: While there have been studies on asthma management, this specific multi-center register approach is relatively novel and aims to fill existing knowledge gaps.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. high dose ICS with ≥ 1000 μg beclomethasone (powder) or equivalent in combination with LABA or leukotriene modifier/theophylline) for the previous year or
  2. 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
  3. 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:

  1. Prolonged therapy with high dose inhaled steroid (ICS) (\> 400 μg Budesonide equivalent /\> 200 μg fluticasone alone); or
  2. 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
  3. 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).

Exclusion Criteria:

* Life-expectancy \<6 months · Insufficient knowledge of project language

Where this trial is running

Liestal, Basel-Landschaft and 9 other locations

• Cantonal Hospital Baselland Liestal — Liestal, Basel-Landschaft, 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)

Study contacts

• Principal investigator: Jörg Leuppi — Kantonsspital Baselland Liestal
• Study coordinator: Jörg Leuppi

Conditions: Severe Asthma, Asthma, Severe, Register