xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06035289</url>
    </required_header>
    <id_info>
      <org_study_id>2018-13614</org_study_id>
      <nct_id>NCT06035289</nct_id>
    </id_info>
    <brief_title>Register Schweres Asthma - German Asthma Net e.V.</brief_title>
    <official_title>Klinisches Register Schweres Asthma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>German Asthma Net e.V.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>GlaxoSmithKline</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sanofi</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Chiesi Farmaceutici S.p.A.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>German Asthma Net e.V.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The German Asthma Net e.V. focusses on science and research in patients with severe asthma.&#xD;
        This includes, in particular, the optimization of medical care and treatment for patients&#xD;
        with severe asthma as well as the elucidation and information. An unavoidable basis for a&#xD;
        better understanding of severe asthma is the registration and comprehensive characterization&#xD;
        of a large patient population. To date, there are only few reliable data on incidence,&#xD;
        prevalence, phenotypes and treatment of patients with severe asthma. For this reason, the&#xD;
        German Asthma Net e.V. was established in December 2011 as a clinical registry for patients&#xD;
        with severe asthma, initially set up on a national basis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sociodemographic parameters (e.g., gender, date of birth) and medical parameters (diagnosis,&#xD;
        therapy) are entered in the register. In addition, data on lung function, laboratory values&#xD;
        (IgE and eosinophil granulocytes), asthma control (symptoms, nocturnal awakenings, on-demand&#xD;
        medication, exacerbations), smoking status, and concomitant therapy (inhalable&#xD;
        corticosteroids, bronchodilators, and systemic steroids) are collected. This information will&#xD;
        be collected at the baseline visit, and then once a year at a follow up visit, for fifteen&#xD;
        years.&#xD;
  &#xD;
        Participants will be assigned a unique study ID to protect the confidentiality of their&#xD;
        personal health care information. Personal data and register data are on separate servers and&#xD;
        thus meet the requirements of data protection.&#xD;
  &#xD;
        The primary purpose is to establish a clinical registry for patients with severe asthma. The&#xD;
        number of patients with severe asthma at a single center or practice is usually small, so&#xD;
        several centers (clinics and practices) in Germany have joined together to form the German&#xD;
        Asthma Net e.V. to optimize the diagnostic evaluation and treatment of patients with severe&#xD;
        asthma.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2011</start_date>
    <completion_date type="Anticipated">November 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2026</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Symptom Control</measure>
      <time_frame>Baseline, four months, yearly for up to 15 years</time_frame>
      <description>Changes in symptom control at baseline and during the follow-up period and at study end using the Asthma Control Test (ACT).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Exacerbations</measure>
      <time_frame>Baseline, four months, yearly for up to 15 years</time_frame>
      <description>Number of exacerbation with/without hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Utilization of the health care system</measure>
      <time_frame>Baseline, yearly for up to 15 years</time_frame>
      <description>Number of visits at a pneumologist/ specialist, number of emergency consultations, number of hospitalizations, number of rehabilitation stays</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptoms and health-related quality of life</measure>
      <time_frame>Baseline, yearly for up to 15 years</time_frame>
      <description>Asthma Control Test (ACT: 5 questions, scale 1- 5, min score 5, max score 25, the lower the score the better the Asthma control)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life Questionnaire</measure>
      <time_frame>Baseline, yearly for up to 15 years</time_frame>
      <description>Mini Asthma Quality of Life Questionnaire (Mini-AQLQ: 15 questions, scale 1 to 7, min score 15, max score 105, the higher the score, the better the quality of life)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Asthma Control Questionnaire</measure>
      <time_frame>Baseline, yearly for up to 15 years</time_frame>
      <description>Asthma Control Questionnaire ACQ: 5 questions, scale 0 to 6, min score 0, max score 30, the lower the score the better the Asthma control)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Forced Exhaled Volume in 1 second (FEV1)</measure>
      <time_frame>Baseline, 4 months, yearly for up to 15 years</time_frame>
      <description>FEV1 at consultation, FEV1 last 2 years, changes in FEV1 in liter from the target value</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Forced Vital Capacity (FVC)</measure>
      <time_frame>Baseline, 4 months, yearly for up to 15 years</time_frame>
      <description>FVC at consultation, FEV1 last 2 years, changes in FEV1 in liter from the target value</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in medication</measure>
      <time_frame>Baseline, 4 months, yearly for up to 15 years</time_frame>
      <description>changes in substances if there is a new drug used.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in dose in mg</measure>
      <time_frame>4 months, yearly for up to 15 years</time_frame>
      <description>Changes in dose in mg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fraction of exhaled nitric oxide (FeNo)</measure>
      <time_frame>Baseline, 4 months, yearly for up to 15 years</time_frame>
      <description>Changes in FeNo in ppb</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood Gas analysis</measure>
      <time_frame>Baseline, 4 months, yearly for up to 15 years</time_frame>
      <description>pO2 in kPa/ mmHg, pCO2 in kPa/ mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood Gas analysis</measure>
      <time_frame>Baseline, 4 months, yearly for up to 15 years</time_frame>
      <description>Blood-oxygen saturation in %</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Leucocytes</measure>
      <time_frame>Baseline, 4 months, yearly for up to 15 years</time_frame>
      <description>Changes in leucocytes in nl</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neutrophilic granulocytes</measure>
      <time_frame>Baseline, 4 months, yearly for up to 15 years</time_frame>
      <description>Changes in Neutrophilic granulocytes in nl or %</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Eosinophilic granulocytes</measure>
      <time_frame>Baseline, 4 months, yearly for up to 15 years</time_frame>
      <description>Changes in Eosinophilic granulocytes in µl or %</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CO diffusion capacity</measure>
      <time_frame>Baseline, yearly for up to 15 years</time_frame>
      <description>Changes in mmol/min/kPa/ %</description>
    </secondary_outcome>
    <enrollment type="Anticipated">4500</enrollment>
    <condition>Severe Asthma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients presenting to participating study center (pulmonologists in private practice or in&#xD;
          pulmonary departments in hospital)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Definition: Severe asthma in children and adolescents&#xD;
  &#xD;
          Poor symptom control in the last year despite (medium to) high doses of anti-inflammatory&#xD;
          maintenance treatment:&#xD;
  &#xD;
          (i) Age 6-18 years (at inclusion) (ii) Asthma diagnosis made by a medical doctor (iii)&#xD;
          Potential differential diagnoses excluded (iv) Good compliance and trained inhalation&#xD;
          technique (v) Evidence of:&#xD;
  &#xD;
          a. Positive bronchodilator reversibility testing (≥ 12% increase in FEV1 after SABA) or b.&#xD;
          Significant bronchial hyperreactivity (BHR) after unspecific provocation test (e.g.&#xD;
          methacholine challenge or treadmill) according to ATS criteria (Am J Respir Crit Care Med&#xD;
          2000) (vi) High level of treatment:&#xD;
  &#xD;
            1. Maintenance treatment with high doses of ICS (&gt;400 μg budesonide or equivalent / ≥ 200&#xD;
               μg of fluticasone as monotherapy) or&#xD;
  &#xD;
            2. Maintenance treatment with medium to high doses of ICS (≥400 μg budesonide or&#xD;
               equivalent / ≥ 200 μg fluticasone) combined with LABA and/or LTRA and/or theophylline&#xD;
               or&#xD;
  &#xD;
            3. Treatment with oral steroids for ≥ 3 months (vii) Poor asthma control:&#xD;
  &#xD;
          a. Inadequate symptom in the past 4 weeks: i. asthma symptoms ≥3 x / week or use of rescue&#xD;
          medication ≥3 x / week; or ii. activity limitations due to asthma; or iii. any nighttime&#xD;
          asthma symptoms; or b. ≥ 1 exacerbation in the last year with ≥ 3 days of OCS treatment or&#xD;
          hospitalisation or b. Poor lung function with reduced Tiffeneau index or FEV1 at inclusion&#xD;
          (viii) written informed consent (parent or legal guardian)&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
          (i) Diagnosis of other obstructive or systemic pulmonary diseases (e.g. cystic fibrosis,&#xD;
          COPD) despite BPD at inclusion (ii) Other congenital lung diseases or pulmonary&#xD;
          malformations (iii) Other significant chronic diseases (iv) Congenital or acquired heart&#xD;
          defects with significant functional limitations&#xD;
  &#xD;
          Definition: Severe asthma in adults&#xD;
  &#xD;
          High level of treatment (A), i.e. step 5 of GINA guideline or (B) medium level of treatment&#xD;
          and poor symptom control:&#xD;
  &#xD;
          (A) High level of treatment:&#xD;
  &#xD;
            1. Maintenance treatment with high-dose inhaled corticosteroids (≥ 1000 μg beclomethasone&#xD;
               (BDP, powder) or equivalent) in combination with LABA or LTRA or theophylline or&#xD;
  &#xD;
            2. Maintenance treatment with oral corticosteroids (OCS) for ≥3 months independent of&#xD;
               other asthma treatments or&#xD;
  &#xD;
            3. Treatment with monoclonal antibodies independent of other asthma treatments&#xD;
  &#xD;
          B) Medium level of treatment and poor symptom control:&#xD;
  &#xD;
            1. Maintenance treatment with medium to high doses of ICS (≥ 500 μg BDP (powder) or&#xD;
               equivalent) in combination with LABA or LTRA or theophylline and&#xD;
  &#xD;
            2. Poor symptom control:&#xD;
  &#xD;
          (i) asthma symptoms ≥ 3 x / week or use of rescue medication ≥ 3 x / week; or (ii)&#xD;
          activities limited due to asthma; or (iii) any nighttime asthma symptoms; or (iv) ≥ 1&#xD;
          exacerbation in the last year with ≥ 3 days of OCS treatment or (v) FEV1&lt;80% of predicted&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Stephanie Korn, Prof.</last_name>
      <phone>+49 (0)1577-6948673</phone>
      <email>info@german-asthma-net.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mandy Seefeldt</last_name>
      <phone>+49 (0)1577-6948673</phone>
      <email>mandy.seefeldt@german-asthma-net.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kardiologische und fachinternistische ÜBAG Dr. Sandrock und Partner</name>
        <address>
          <city>Altdorf</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Markus Gasplmayr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Universitätsklinikum Augsburg Kinderpulmologie und -allergologie</name>
        <address>
          <city>Augsburg</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Praxis Dr. Grün</name>
        <address>
          <city>Bad Windsheim</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Borghild Grün, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CIMS Studienzentrum Bamberg</name>
        <address>
          <city>Bamberg</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joachim Kirschner, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lungenpraxis Tegel</name>
        <address>
          <city>Berlin</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Thomas Hering</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Evangelisches Klinikum Bethel v. Bodelschwinghsche Stiftungen Bethel</name>
        <address>
          <city>Bielefeld</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eckard Hamelmann, Prof.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Helios Lungen- und Allergiezentrum Bonn</name>
        <address>
          <city>Bonn</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marcus Joest</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Universitätsnedizin Bonn</name>
        <address>
          <city>Bonn</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dirk Skowasch, Prof.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Zentrum für Kinderheilkunde, Klinik und Poliklinik für Allgemeine Pädiatrie, Allergieabteilung</name>
        <address>
          <city>Bonn</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Prof.-Hess-Kinderklinik Bremen-Mitte</name>
        <address>
          <city>Bremen</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Petra Kaiser-Labusch</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lungenpraxis Medicum Böblingen</name>
        <address>
          <city>Böblingen</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Stefan Veitshans, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>MECS Cottbus</name>
        <address>
          <city>Cottbus</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Frank Käßner, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Evangelisches Krankenhaus Düsseldorf</name>
        <address>
          <city>Düsseldorf</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Monika Gappa, Prof.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lunge im Zentrum</name>
        <address>
          <city>Erlangen</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sabine Lampert, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Universitätsmedizin Essen</name>
        <address>
          <city>Essen</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Pneumologie am Schelztor Esslingen</name>
        <address>
          <city>Esslingen</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Silke Hellmich, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Praxis Dr. Herden</name>
        <address>
          <city>Freising</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Markus Herden, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>ALB FILS Kliniken</name>
        <address>
          <city>Göppingen</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Timo Deininger, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hamburger Institut für Therapieforschung GmbH</name>
        <address>
          <city>Hamburg</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Margret Jandl, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Medizinische Hochschule Hannover</name>
        <address>
          <city>Hanover</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hendrik Suhling, PD Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Praxisgmeinschaft Dr. Abenhardt und Jochen Hinrichs-Pavlik</name>
        <address>
          <city>Heidelberg</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Birgit Abenhardt, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Thoraxklinik Heidelberg gGmbH</name>
        <address>
          <city>Heidelberg</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Felix Herdt, Prof.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lungenarztpraxis Dr. Hubatsch</name>
        <address>
          <city>Heilbronn</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Atemwegszentrum Kaiserslautern</name>
        <address>
          <city>Kaiserslautern</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Florian Schmitz, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>MVZ Klinikum Kempten</name>
        <address>
          <city>Kempten</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kim Husemann, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Pneumologische Gemeinschaftspraxis</name>
        <address>
          <city>Koblenz</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Olaf Schmidt, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lungenpraxis Konstanz</name>
        <address>
          <city>Konstanz</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>DONAUISAR Klinikum Deggendorf-Dingolfing-Landau</name>
        <address>
          <city>Landau an der Isar</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Christian Geltner, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Asthma Allergiezentrum</name>
        <address>
          <city>Leverkusen</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Norbert Mülleneisen</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lungenfachklinik Medizinische Klinik I, Pneumologie</name>
        <address>
          <city>Löwenstein</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Monika Stephan, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>IKF Pneumologie GmbH &amp; Co. KG</name>
        <address>
          <city>Mainz</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Stephanie Korn, Prof.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lungenfacharztpraxis Dr. C. Lüttecke-Hecht</name>
        <address>
          <city>Mainz</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Camilla Lüttecke-Hecht, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lungenfacharztpraxis Dr. Gall</name>
        <address>
          <city>Mainz</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Univsersitätsmedizin Mainz</name>
        <address>
          <city>Mainz</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Roland Buhl, Prof.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dr. von Haunersches Kinderspital</name>
        <address>
          <city>München</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bianca Schaub, Prof.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>LMU Klinikum der Universität München, Ambulanz für Schweres Asthma (Erwachsene)</name>
        <address>
          <city>München</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Katrin Milger-Kneidinger, PD Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Universitätsklinikum Regensburg</name>
        <address>
          <city>Regensburg</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Christian Schulz, Prof.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Universitätsmedizin Rostock, Med. Klinik I, Abt. Pneumologie &amp; Interdiszipl. Internistische Intensivmedizin</name>
        <address>
          <city>Rostock</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Lungenpraxis Schleswig/ Respiratio</name>
        <address>
          <city>Schleswig</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andreas Deimling, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ambulante Pneumologie mit Allergiezentrum (BAG)</name>
        <address>
          <city>Stuttgart</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rainer Ehmann</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>RBK Lungenzentrum Stuttgart</name>
        <address>
          <city>Stuttgart</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Claus Neurohr, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Internistische Gemeinschaftspraxis Bitburg-Trier</name>
        <address>
          <city>Trier</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Patrick Albrecht, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Uniklinik Ulm, Sektion Pneumologie, Klinik für Innere Medizin II</name>
        <address>
          <city>Ulm</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cornelia Kropf-Sanchen</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Fachkliniken Wangen</name>
        <address>
          <city>Wangen Im Allgäu</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Susanne Hirschmann</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Marien-Hospital, Klinik für Kinder- und Jugendmedizin</name>
        <address>
          <city>Wesel</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cordula Körner-Rettberg, Dr.</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <link>
      <url>http://www.germanasthmanet.de</url>
      <description>Website</description>
    </link>
    <results_reference>
      <citation>Bal C, Pohl W, Milger K, Skowasch D, Schulz C, Gappa M, Koerner-Rettberg C, Jandl M, Schmidt O, Zehetmayer S, Taube C, Hamelmann E, Buhl R, Korn S, Idzko M; German Asthma Net (GAN) study group. Characterization of Obesity in Severe Asthma in the German Asthma Net. J Allergy Clin Immunol Pract. 2023 Jul 4:S2213-2198(23)00714-6. doi: 10.1016/j.jaip.2023.06.049. Online ahead of print.</citation>
      <PMID>37406803</PMID>
    </results_reference>
    <results_reference>
      <citation>Milger K, Suhling H, Skowasch D, Holtdirk A, Kneidinger N, Behr J, Timmermann H, Schulz C, Schmidt O, Ehmann R, Hamelmann E, Idzko M, Taube C, Lommatzsch M, Buhl R, Korn S. Response to Biologics and Clinical Remission in the Adult German Asthma Net Severe Asthma Registry Cohort. J Allergy Clin Immunol Pract. 2023 Jun 8:S2213-2198(23)00646-3. doi: 10.1016/j.jaip.2023.05.047. Online ahead of print.</citation>
      <PMID>37301433</PMID>
    </results_reference>
    <results_reference>
      <citation>Korn S, Milger K, Skowasch D, Schulz C, Mohrlang C, Wernitz M, Paulsson T, Hennig M, Buhl R. Real-World Experience on the Use of Mepolizumab from the Severe Asthma Registry of the German Asthma Net (MepoGAN-Study). J Asthma Allergy. 2023 May 11;16:541-552. doi: 10.2147/JAA.S403286. eCollection 2023.</citation>
      <PMID>37197193</PMID>
    </results_reference>
    <results_reference>
      <citation>Milger K, Skowasch D, Hamelmann E, Mummler C, Idzko M, Gappa M, Jandl M, Korner-Rettberg C, Ehmann R, Schmidt O, Taube C, Holtdirk A, Timmermann H, Buhl R, Korn S. Bronchodilator reversibility in the GAN severe asthma cohort. J Investig Allergol Clin Immunol. 2022 Aug 24:0. doi: 10.18176/jiaci.0850. Online ahead of print.</citation>
      <PMID>36000830</PMID>
    </results_reference>
    <results_reference>
      <citation>Bal C, Idzko M, Skrgat S, Koch A, Milger K, Schulz C, Zehetmayer S, Hamelmann E, Buhl R, Korn S; collaborators from the German Asthma Net (GAN). Fraction of exhaled nitric oxide is associated with disease burden in the German Asthma Net severe asthma cohort. Eur Respir J. 2022 Jun 2;59(6):2101233. doi: 10.1183/13993003.01233-2021. Print 2022 Jun.</citation>
      <PMID>35273030</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Registry</keyword>
    <keyword>Biological</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06035289
  org study id: 2018-13614
  nct id: NCT06035289
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The German Asthma Net e.V. focusses on science and research in patients with severe asthma.
        This includes, in particular, the optimization of medical care and treatment for patients
        with severe asthma as well as the elucidation and information. An unavoidable basis for a
        better understanding of severe asthma is the registration and comprehensive characterization
        of a large patient population. To date, there are only few reliable data on incidence,
        prevalence, phenotypes and treatment of patients with severe asthma. For this reason, the
        German Asthma Net e.V. was established in December 2011 as a clinical registry for patients
        with severe asthma, initially set up on a national basis.
  Sociodemographic parameters (e.g., gender, date of birth) and medical parameters (diagnosis,
        therapy) are entered in the register. In addition, data on lung function, laboratory values
        (IgE and eosinophil granulocytes), asthma control (symptoms, nocturnal awakenings, on-demand
        medication, exacerbations), smoking status, and concomitant therapy (inhalable
        corticosteroids, bronchodilators, and systemic steroids) are collected. This information will
        be collected at the baseline visit, and then once a year at a follow up visit, for fifteen
        years.
  
        Participants will be assigned a unique study ID to protect the confidentiality of their
        personal health care information. Personal data and register data are on separate servers and
        thus meet the requirements of data protection.
  
        The primary purpose is to establish a clinical registry for patients with severe asthma. The
        number of patients with severe asthma at a single center or practice is usually small, so
        several centers (clinics and practices) in Germany have joined together to form the German
        Asthma Net e.V. to optimize the diagnostic evaluation and treatment of patients with severe
        asthma.
  observational model: Cohort
  time perspective: Prospective
  measure: Symptom Control
  time frame: Baseline, four months, yearly for up to 15 years
  description: Changes in symptom control at baseline and during the follow-up period and at study end using the Asthma Control Test (ACT).
  measure: Exacerbations
  time frame: Baseline, four months, yearly for up to 15 years
  description: Number of exacerbation with/without hospitalization
  measure: Utilization of the health care system
  time frame: Baseline, yearly for up to 15 years
  description: Number of visits at a pneumologist/ specialist, number of emergency consultations, number of hospitalizations, number of rehabilitation stays
  measure: Symptoms and health-related quality of life
  time frame: Baseline, yearly for up to 15 years
  description: Asthma Control Test (ACT: 5 questions, scale 1- 5, min score 5, max score 25, the lower the score the better the Asthma control)
  measure: Quality of Life Questionnaire
  time frame: Baseline, yearly for up to 15 years
  description: Mini Asthma Quality of Life Questionnaire (Mini-AQLQ: 15 questions, scale 1 to 7, min score 15, max score 105, the higher the score, the better the quality of life)
  measure: Asthma Control Questionnaire
  time frame: Baseline, yearly for up to 15 years
  description: Asthma Control Questionnaire ACQ: 5 questions, scale 0 to 6, min score 0, max score 30, the lower the score the better the Asthma control)
  measure: Forced Exhaled Volume in 1 second (FEV1)
  time frame: Baseline, 4 months, yearly for up to 15 years
  description: FEV1 at consultation, FEV1 last 2 years, changes in FEV1 in liter from the target value
  measure: Forced Vital Capacity (FVC)
  time frame: Baseline, 4 months, yearly for up to 15 years
  description: FVC at consultation, FEV1 last 2 years, changes in FEV1 in liter from the target value
  measure: Changes in medication
  time frame: Baseline, 4 months, yearly for up to 15 years
  description: changes in substances if there is a new drug used.
  measure: Changes in dose in mg
  time frame: 4 months, yearly for up to 15 years
  description: Changes in dose in mg
  measure: Fraction of exhaled nitric oxide (FeNo)
  time frame: Baseline, 4 months, yearly for up to 15 years
  description: Changes in FeNo in ppb
  measure: Blood Gas analysis
  time frame: Baseline, 4 months, yearly for up to 15 years
  description: pO2 in kPa/ mmHg, pCO2 in kPa/ mmHg
  measure: Blood Gas analysis
  time frame: Baseline, 4 months, yearly for up to 15 years
  description: Blood-oxygen saturation in %
  measure: Leucocytes
  time frame: Baseline, 4 months, yearly for up to 15 years
  description: Changes in leucocytes in nl
  measure: Neutrophilic granulocytes
  time frame: Baseline, 4 months, yearly for up to 15 years
  description: Changes in Neutrophilic granulocytes in nl or %
  measure: Eosinophilic granulocytes
  time frame: Baseline, 4 months, yearly for up to 15 years
  description: Changes in Eosinophilic granulocytes in µl or %
  measure: CO diffusion capacity
  time frame: Baseline, yearly for up to 15 years
  description: Changes in mmol/min/kPa/ %
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Stephanie Korn, Prof.
  phone: +49 (0)1577-6948673
  email: info@german-asthma-net.de
  last name: Mandy Seefeldt
  phone: +49 (0)1577-6948673
  email: mandy.seefeldt@german-asthma-net.de
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
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  facility: 
  status: Recruiting
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  status: Recruiting
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  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  facility: 
  status: Recruiting
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  status: Recruiting
  contact: 
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  status: Active, not recruiting
  facility: 
  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Active, not recruiting
  facility: 
  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Germany
  url: http://www.germanasthmanet.de
  description: Website
  citation: Bal C, Pohl W, Milger K, Skowasch D, Schulz C, Gappa M, Koerner-Rettberg C, Jandl M, Schmidt O, Zehetmayer S, Taube C, Hamelmann E, Buhl R, Korn S, Idzko M; German Asthma Net (GAN) study group. Characterization of Obesity in Severe Asthma in the German Asthma Net. J Allergy Clin Immunol Pract. 2023 Jul 4:S2213-2198(23)00714-6. doi: 10.1016/j.jaip.2023.06.049. Online ahead of print.
  PMID: 37406803
  citation: Milger K, Suhling H, Skowasch D, Holtdirk A, Kneidinger N, Behr J, Timmermann H, Schulz C, Schmidt O, Ehmann R, Hamelmann E, Idzko M, Taube C, Lommatzsch M, Buhl R, Korn S. Response to Biologics and Clinical Remission in the Adult German Asthma Net Severe Asthma Registry Cohort. J Allergy Clin Immunol Pract. 2023 Jun 8:S2213-2198(23)00646-3. doi: 10.1016/j.jaip.2023.05.047. Online ahead of print.
  PMID: 37301433
  citation: Korn S, Milger K, Skowasch D, Schulz C, Mohrlang C, Wernitz M, Paulsson T, Hennig M, Buhl R. Real-World Experience on the Use of Mepolizumab from the Severe Asthma Registry of the German Asthma Net (MepoGAN-Study). J Asthma Allergy. 2023 May 11;16:541-552. doi: 10.2147/JAA.S403286. eCollection 2023.
  PMID: 37197193
  citation: Milger K, Skowasch D, Hamelmann E, Mummler C, Idzko M, Gappa M, Jandl M, Korner-Rettberg C, Ehmann R, Schmidt O, Taube C, Holtdirk A, Timmermann H, Buhl R, Korn S. Bronchodilator reversibility in the GAN severe asthma cohort. J Investig Allergol Clin Immunol. 2022 Aug 24:0. doi: 10.18176/jiaci.0850. Online ahead of print.
  PMID: 36000830
  citation: Bal C, Idzko M, Skrgat S, Koch A, Milger K, Schulz C, Zehetmayer S, Hamelmann E, Buhl R, Korn S; collaborators from the German Asthma Net (GAN). Fraction of exhaled nitric oxide is associated with disease burden in the German Asthma Net severe asthma cohort. Eur Respir J. 2022 Jun 2;59(6):2101233. doi: 10.1183/13993003.01233-2021. Print 2022 Jun.
  PMID: 35273030
  responsible party type: Sponsor
  mesh term: Asthma