<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/NCT04456270</url>
  </required_header>
  <id_info>
    <org_study_id>GPRI19103</org_study_id>
    <nct_id>NCT04456270</nct_id>
  </id_info>
  <brief_title>Asthma Control in a Dutch Primary Care Population</brief_title>
  <official_title>Asthma Control in a Dutch Primary Care Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>General Practitioners Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>General Practitioners Research Institute</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>
      Rationale: Despite the availability of effective treatment to reach symptom control, nearly&#xD;
      half of the asthma patients remain inadequately controlled. There is a need for timely and&#xD;
      appropriate treatment of patients with uncontrolled asthma. Improving asthma control could be&#xD;
      achieved by a better identification of causes followed by remediating modifiable factors in&#xD;
      primary care or referral to secondary care. However, major gaps in evidence-based asthma&#xD;
      practice exist in primary care. So far, there is a lack of knowledge on the prevalence of&#xD;
      inadequate asthma and associated characteristics.&#xD;
&#xD;
      Objective: The primary objective is to determine the proportion of primary care patients with&#xD;
      inadequate asthma control, as assessed during a regular control consultation with the general&#xD;
      practice nurse.&#xD;
&#xD;
      Study design: This is a non-interventional prospective observational study, taking place in a&#xD;
      real-world primary care setting.&#xD;
&#xD;
      Study population: Patients diagnosed with asthma, who attend a pre-planned primary care&#xD;
      asthma review, are eligible to participate. A limited number of in- and exclusion criteria&#xD;
      will be adopted, to make sure the research population closely resembles the real world.&#xD;
&#xD;
      Main study parameters/endpoints: The primary endpoint is the proportion of patients with&#xD;
      inadequate asthma control. Inadequate asthma control will be defined as an exacerbation in&#xD;
      the past 4 weeks and/or an ACQ6 (i.e., Asthma Control Questionnaire) score &gt;0.75.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Asthma Control Questionnaire</measure>
    <time_frame>week prior to visit to general practice nurse for check-up appointment</time_frame>
    <description>self-reported assessment of asthma symptoms</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">222</enrollment>
  <condition>Asthma</condition>
  <condition>Asthma; Eosinophilic</condition>
  <condition>Asthma Chronic</condition>
  <condition>Asthma; Status</condition>
  <arm_group>
    <arm_group_label>Primary care patients with current asthma</arm_group_label>
    <description>Male and female primary care patients aged ≥18 years of age with clinically diagnosed asthma.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care patients with a current asthma diagnosis, who are scheduled to have in-person&#xD;
        asthma review consultations with a primary care nurse, will be recruited from primary care&#xD;
        practices located in the northern part of the Netherlands. The population includes men and&#xD;
        women ≥18 years of age with clinically diagnosed asthma. The diagnosis of asthma is allowed&#xD;
        to be a clinical diagnosis rendered by a doctor, without the requirement to conduct&#xD;
        additional confirmatory testing. Furthermore, a limited number of in- and exclusion&#xD;
        criteria will be adopted, to make sure the research population closely resembles the real&#xD;
        world.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged ≥ 18 years&#xD;
&#xD;
          -  Physician diagnosis of Asthma&#xD;
&#xD;
          -  Capacity to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy of less than 1 year&#xD;
&#xD;
          -  Inability to understand Dutch&#xD;
&#xD;
          -  Any other condition which, at the GPs and/or investigator's discretion, is believed to&#xD;
             present a safety risk or may impact the study results&#xD;
&#xD;
          -  Patients participating in a clinical trial that may distort outcomes in this&#xD;
             observational study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>GPRI</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 22, 2022</last_update_submitted>
  <last_update_submitted_qc>August 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Pulmonary Eosinophilia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04456270
org study id: GPRI19103
nct id: NCT04456270
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rationale: Despite the availability of effective treatment to reach symptom control, nearly
      half of the asthma patients remain inadequately controlled. There is a need for timely and
      appropriate treatment of patients with uncontrolled asthma. Improving asthma control could be
      achieved by a better identification of causes followed by remediating modifiable factors in
      primary care or referral to secondary care. However, major gaps in evidence-based asthma
      practice exist in primary care. So far, there is a lack of knowledge on the prevalence of
      inadequate asthma and associated characteristics.

      Objective: The primary objective is to determine the proportion of primary care patients with
      inadequate asthma control, as assessed during a regular control consultation with the general
      practice nurse.

      Study design: This is a non-interventional prospective observational study, taking place in a
      real-world primary care setting.

      Study population: Patients diagnosed with asthma, who attend a pre-planned primary care
      asthma review, are eligible to participate. A limited number of in- and exclusion criteria
      will be adopted, to make sure the research population closely resembles the real world.

      Main study parameters/endpoints: The primary endpoint is the proportion of patients with
      inadequate asthma control. Inadequate asthma control will be defined as an exacerbation in
      the past 4 weeks and/or an ACQ6 (i.e., Asthma Control Questionnaire) score >0.75.
observational model: Cohort
time perspective: Prospective
measure: Asthma Control Questionnaire
time frame: week prior to visit to general practice nurse for check-up appointment
description: self-reported assessment of asthma symptoms
arm group label: Primary care patients with current asthma
description: Male and female primary care patients aged ≥18 years of age with clinically diagnosed asthma.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Asthma
mesh term: Pulmonary Eosinophilia
sharing ipd: Undecided