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Swiss Severe Asthma Register

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ClinicalTrials.gov Identifier: NCT03984253
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
AstraZeneca
GlaxoSmithKline
Lungenliga Schweiz
Novartis
Information provided by (Responsible Party):
Prof. Dr. Jörg Leuppi, Cantonal Hosptal, Baselland

Brief Summary:

Asthma is one of the most common chronic diseases. It is characterized by chronic inflammation of the airways 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. It is not about a single entity, but different diseases or symptoms that overlap in a variety of ways. The various classification options of asthma, for example, according to severity, by degree of asthma, by the predominantly existing pattern of inflammation (allergic or intrinsic) or according to triggers, reflect this heterogeneity. Despite improved therapy, the prevalence and morbidity of asthma has increased worldwide in recent years. Asthma is a serious and growing global health problem with around 300 million people of all ages affected in all countries. It is estimated that approximately 250'000 people die prematurely each year due to their asthma. Based on the SAPALDIA-study, the prevalence of asthma in Switzerland is estimated to be around 2-8%. Asthma is found to be a major healthcare cost factor for Switzerland, estimated to CHF 1'200 million per year. Despite existing guidelines and effective medication, asthma is not only a major burden to the health care system but also to the patients, because health care professionals and patients underestimate disease severity, overestimate asthma control or do not adhere to recommended management. Further, severe asthma should not be equated with uncontrolled asthma since in the latter disease control is often not attained because of too poor inhaler technique, poor medication adherence, comorbidities, complications as well as repeated exposure to sensitizing or irritant agents. Severe asthma is often associated with a high risk of experiencing severe exacerbations which can even lead to death, and represent a large part of the total costs for asthma care.

Several severe asthma cohorts and registries are already existing and reported in the literature, which aimed to collect data and information about patients with severe asthma. Most epidemiological studies on severe asthma are limited to onetime cross-sectional studies. There is little data available on new surveys using the same methodology and in the same collectives at a later time. The treatment and care situation of severe asthma is not only in Switzerland insufficient. The data of such a register offers a fascinating opportunity to describe the day-to-day care of these patients in a descriptive way and thus making the treatment and care transparent and optimizing it. A small proportion of patients, estimated at less than 5% of all people with asthma, have severe asthma. Patients with severe asthma require systematic assessment and specialist care in dedicated respiratory centers. The key role of these centers is to improve outcomes for patients with severe asthma and to act as gatekeepers to ensure appropriate access to novel high cost therapies including biologicals and interventional therapies such as thermoplasty. These treatments will require careful monitoring to ensure that they are prescribed to the correct patient population with specialist assessment of efficacy to prevent inappropriate prescribing, exposure of patients to unnecessary risks and excessive costs. Therefore, a Swiss Severe Asthma Register or collaboration with an already existing register is needed to prospectively collect data about severe asthma in Switzerland.


Condition or disease
Severe Asthma

Detailed Description:

The overall objective is to establish a clinical register for patients with severe asthma. Since the number of patients with severe asthma at a single center is usually low, it will be important to collect data in a multi-center system to optimize the diagnostic evaluation and treatment of patients with severe asthma. So far, there is little reliable information about the frequency, phenotype and therapy of patients with severe asthma. The construction of a clinical register should close this gap. The primary objective is to show changes in symptoms control during follow up period and at study end by using the Asthma Control Test (ACT). Secondary endpoints are to collect data to better understand asthma's natural history in patients with severe asthma. The examination will be based on the assessment of the parameters specified under "outcomes".

Patients presenting to participating study center (pulmonologists in private practice or in pulmonary departments in hospital within Switzerland) with severe asthma will be asked to take part in this study when corresponding to the eligibility criteria. All patients with severe asthma will be included in the register only after detailed information and written consent. After four months (for specific therapies) and after 12 months, patients should be re-evaluated for up to 15 years. These follow-up data will also be recorded in the register. During the follow-up visits, the same parameters will be collected as during the initial Baselineexamination (some parameters will be omitted, for example, therapy received or requested for the defined period of the last 12 months, etc.). Severe asthma patients receiving a new specific therapy, e.g. obtained with antibodies, but who cannot be included in the register with the complete parameter profile due to time or capacity reasons of the centers, should be recorded at least with defined basic data and a reduced number of parameters in the register. These parameters include according to the specific asthma approved specific therapies, socio-demographic data, lung function values, laboratory values, parameters of asthma control, smoking status and add-on- therapy. This should make it possible to record a subgroup of severe asthmatics that are suitable for antibody therapy and at the same time offer the attending physician the opportunity to adequately document these complex and expensive therapies by recording the defined parameters. In these patients, an evaluation of the therapy response should be carried out after four months and documented in the register. Thereafter, there is an annual follow-up. At any time, these patients can be transferred to the full version of the register by entering the missing parameters. Patients for whom only the basic data is available (basic version) as well as patients with complete parameter profile in the register are kept in the same database and can be evaluated together. In general, no register-specific examinations will be carried out, but only parameters anyway recorded routinely.

Since this is a cohort study, no sample size calculation can be calculated. Evaluations are carried out continuously. The collective of the data should be described by descriptive statistics concerning the basic data as well as the data of the function diagnostics. Subentities of severe asthma should be identified by a cluster analysis.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: Swiss Severe Asthma Register
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : February 28, 2034
Estimated Study Completion Date : February 28, 2034

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
Severe Asthma
All patients with severe asthma who will be treated in the participating centers should be continuously enrolled in the register.



Primary Outcome Measures :
  1. changes in symptom control during follow-up period and at study end using the Asthma Control Test (ACT). [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]

Secondary Outcome Measures :
  1. Number of exacerbation with/without hospitalization [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
  2. Utilization of the health care system [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
    • Number of general practitioner (GP) visit
    • Number of specialist visit
    • Number of emergency visit
    • Number of hospitalization due to exacerbation or due to other causes
    • Number of rehabilitation stay
    • Number of cure stay

  3. Mini Asthma Quality of life Questionnaire (Mini-AQLQ) [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
    • Symptoms
    • Limitation in daily activities
    • Emotional state
    • Environmental stimuli

  4. Symptoms and health-related quality of life [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
    o Asthma Therapy Assessment Questionnaire (ATAQ)

  5. Changes in medication [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
  6. Changes in forced vital capacity (FVC) [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
  7. Changes in Tiffeneau (FEV1/FVC) [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
  8. Changes in exhaled NO [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
  9. Changes in forced expiratory volume in 1 second (FEV1) [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
  10. Leucocytes [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
  11. Neutrophilic granulocytes [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
  12. Eosinophilic granulocytes [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
  13. Serum immunoglobulin (Ig)E [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
  14. Blood gas Analysis (pO2, pCO2,sO2) [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]
  15. Mortality [ Time Frame: After four months, and after 12 months, then every year up to 15 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984253


Contacts
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Contact: Jörg Leuppi +41619252181 Joerg.leuppi@ksbl.ch

Locations
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Switzerland
Cantonal Hospital Baselland Liestal Recruiting
Liestal, BL, Switzerland, 4410
Contact: Jörg Leuppi       joerg.leuppi@ksbl.ch   
Universitätsklinik für Pneumologie, Inselspital Not yet recruiting
Bern, Switzerland
Contact: Christoph Von Garnier       christoph.vongarnier@insel.ch   
Pneumologie, Kantonsspital Graubünden Not yet recruiting
Chur, Switzerland
Contact: Thomas Rothe       thomas.rothe@gmx.ch   
Klinik für Pneumologie, Hochgebirgsklinik Davos Not yet recruiting
Davos, Switzerland
Contact: Hans-Werner Duchna       hans-werner.duchna@hgk.ch   
Hôpitaux Universitaires Genève Not yet recruiting
Genf, Switzerland
Contact: Florian Charbonnier       florian.charbonnier@hcuge.ch   
Pneumologia, Ospedale Civico Not yet recruiting
Lugano, Switzerland
Contact: Andrea Azzola       andrea.azzola@eoc.ch   
Hôpital du valais, sion Not yet recruiting
Sion, Switzerland
Contact: Pierre-Olivier Bridevaux       pierre-olivier.bridevaux@hospitalvs.ch   
Klinik für Pneumologie und Schlafmedizin, Kantonsspital St.Gallen Not yet recruiting
St.Gallen, Switzerland
Contact: Lucas Kern       lukas.kern@kssg.ch   
Klinik für Pneumologie, Universitätsspital Zürich Not yet recruiting
Zürich, Switzerland
Contact: Christian Clarenbach       christian.clarenbach@usz.ch   
Sponsors and Collaborators
Prof. Dr. Jörg Leuppi
AstraZeneca
GlaxoSmithKline
Lungenliga Schweiz
Novartis
Investigators
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Principal Investigator: Jörg Leuppi Kantonsspital Baselland Liestal

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Responsible Party: Prof. Dr. Jörg Leuppi, Professor of Internal Medicine, Cantonal Hosptal, Baselland
ClinicalTrials.gov Identifier: NCT03984253     History of Changes
Other Study ID Numbers: 2018-01553
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Jörg Leuppi, Cantonal Hosptal, Baselland:
Asthma
Severe
Register

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases