<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/NCT03030638</url>
  </required_header>
  <id_info>
    <org_study_id>1222.53</org_study_id>
    <nct_id>NCT03030638</nct_id>
  </id_info>
  <brief_title>Drug Utilization Study for Olodaterol</brief_title>
  <official_title>Drug Utilization Study for Olodaterol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RTI health solutions, US</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boehringer Ingelheim</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>
      This study aims to characterise the use of single-agent olodaterol and single-agent&#xD;
      indacaterol, the only marketed long-acting beta2-agonist (LABA)s authorised for chronic&#xD;
      obstructive pulmonary disease (COPD), but not for asthma, in clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Boehringer Ingelheim GmbH (BI) developed olodaterol, an inhaled long-acting beta2-agonist&#xD;
      (LABA), for the indication of chronic obstructive pulmonary disease (COPD). Because the use&#xD;
      of LABAs has been associated with increased morbidity and mortality in patients with asthma,&#xD;
      the health authorities requested the conduct of a post-approval drug utilisation study to&#xD;
      assess potential off-label use of olodaterol in asthma and to characterise the use of&#xD;
      olodaterol in clinical practice. The single agent indacaterol, the only other marketed LABA&#xD;
      authorised in clinical practice for COPD but not for asthma, will also be assessed. Study&#xD;
      objectives include the following: (1) Quantify the frequency of off-label use of olodaterol&#xD;
      and indacaterol among new users of these medications; and (2) Describe the baseline&#xD;
      characteristics of new users of olodaterol and indacaterol. This cross-sectional study will&#xD;
      use information among new users of olodaterol or indacaterol collected in the following&#xD;
      healthcare databases: the PHARMO Database Network in the Netherlands, the National Registers&#xD;
      in Denmark, and the IMS Health Information Solutions (IMS) Real-World Evidence (RWE)&#xD;
      Longitudinal Patient Database (LPD) in France. The source population is all patients enrolled&#xD;
      in the selected study databases at the date olodaterol became available in each database's&#xD;
      country. The study groups are those patients from the source population who receive a first&#xD;
      dispensing for single-agent formulations of olodaterol for the primary objective or&#xD;
      indacaterol for the secondary objective and have at least 12 months of continuous enrolment&#xD;
      in the study databases. The study will describe the number and proportion of new users by&#xD;
      indication and potential off-label use and according to medical history and use of&#xD;
      co-medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">March 31, 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Off-label Use of Olodaterol Among New Users</measure>
    <time_frame>01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.</time_frame>
    <description>Percentage of off-label use of olodaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded Chronic Obstructive Pulmonary Disease (COPD) diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma. Index date is defined as the date an eligible patient receives the first dispensing of olodaterol or indacaterol during the study period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline Characteristics of New Users of Olodaterol: Age</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline characteristics of patients in treatment group by data source: Age</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline Characteristics of New Users of Olodaterol: Gender</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline characteristics of patients in treatment group by data source: Gender</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Off-label Use of Indacaterol Among New Users</measure>
    <time_frame>01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.</time_frame>
    <description>Percentage of off-label use of Indacaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded COPD diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Characteristics of New Users of Indacaterol: Age</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline characteristics of patients in treatment group by data source: Age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Characteristics of New Users of Indacaterol: Gender</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline characteristics of patients in treatment group by data source: Gender</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">27606</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Olodaterol</arm_group_label>
    <description>Patients initiating Olodaterol for the first time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Indacaterol</arm_group_label>
    <description>Patients initiating Indacaterol for the first time</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olodaterol</intervention_name>
    <description>Drug</description>
    <arm_group_label>Olodaterol</arm_group_label>
    <other_name>STRIVERDI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indacaterol</intervention_name>
    <description>Drug</description>
    <arm_group_label>Indacaterol</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study source population includes all patients enrolled in the selected study databases&#xD;
        at the date both olodaterol and indacaterol are available in each database's country. The&#xD;
        study is planned to be conducted in the following databases: the PHARMO Database Network in&#xD;
        the Netherlands, the National Registers in Denmark, and the Real-World Evidence (RWE)&#xD;
        Longitudinal Patient Database (LPD) in France.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  receive a first prescription/dispensing for single-agent formulations of olodaterol or&#xD;
             indacaterol during the study period (no prescriptions/dispensings ever before)&#xD;
&#xD;
          -  patients must have at least 12 consecutive months of enrolment in the database before&#xD;
             the index date&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - Individuals with missing or implausible values for age or sex will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Days</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus Universitetshospital Skejby</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMS Health Information solutions</name>
      <address>
        <city>Courbevoie</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmo Institute</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>France</country>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <results_first_submitted>March 29, 2019</results_first_submitted>
  <results_first_submitted_qc>March 29, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 27, 2019</results_first_posted>
  <last_update_submitted>March 29, 2019</last_update_submitted>
  <last_update_submitted_qc>March 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2019</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>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olodaterol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 13, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03030638/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03030638/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants recruited in the study are those patients who received a first dispensing for single-agent formulations of olodaterol or indacaterol during the study period and had at least 12 months of continuous enrolment in the study databases prior to index date.</recruitment_details>
      <pre_assignment_details>Databases used: PHARMO Database Network in the Netherlands, National Registers in Denmark and IMS Health Information Solutions Real-World Evidence (RWE) Longitudinal Patient Database (LPD) in France. Study periods were 01 March 2014 - 31 December 2016 in PHARMO and Denmark and 01 October 2015 - 30 November 2017 in the IMS RWE LPD panels.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Olodaterol - PHARMO Overall</title>
          <description>Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="P2">
          <title>Indacaterol - PHARMO Overall</title>
          <description>Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="P3">
          <title>Olodaterol - National Health Databases, Denmark</title>
          <description>Patients from the data source National Health Databases, Denmark received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="P4">
          <title>Indacaterol - National Health Databases, Denmark</title>
          <description>Patients from the data source National Health Databases, Denmark received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="P5">
          <title>Olodaterol - IMS RWE LPD General Practitioner (GP) Panel</title>
          <description>Patients from the data source IMS RWE LPD GP panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="P6">
          <title>Indacaterol - IMS RWE LPD GP Panel</title>
          <description>Patients from the data source IMS RWE LPD GP Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="P7">
          <title>Olodaterol - IMS RWE LPD Pulmonologist Panel</title>
          <description>Patients from the data source IMS RWE LPD pulmonologist panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="P8">
          <title>Indacaterol - IMS RWE LPD Pulmonologist Panel</title>
          <description>Patients from the data source IMS RWE LPD Pulmonologist Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1386"/>
                <participants group_id="P2" count="1841"/>
                <participants group_id="P3" count="1712"/>
                <participants group_id="P4" count="6406"/>
                <participants group_id="P5" count="696"/>
                <participants group_id="P6" count="1592"/>
                <participants group_id="P7" count="364"/>
                <participants group_id="P8" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PHARMO-GP (Sub-set of PHARMO Overall)</title>
              <participants_list>
                <participants group_id="P1" count="372"/>
                <participants group_id="P2" count="636"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1386"/>
                <participants group_id="P2" count="1841"/>
                <participants group_id="P3" count="1712"/>
                <participants group_id="P4" count="6406"/>
                <participants group_id="P5" count="696"/>
                <participants group_id="P6" count="1592"/>
                <participants group_id="P7" count="364"/>
                <participants group_id="P8" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Study population: The study population included those patients from the source population who received a first dispensing for single-agent formulations of olodaterol or indacaterol during the study period and had at</population>
      <group_list>
        <group group_id="B1">
          <title>Olodaterol - PHARMO Overall</title>
          <description>Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="B2">
          <title>Indacaterol - PHARMO Overall</title>
          <description>Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="B3">
          <title>Olodaterol - National Health Databases, Denmark</title>
          <description>Patients from the data source National Health Databases, Denmark received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="B4">
          <title>Indacaterol - National Health Databases, Denmark</title>
          <description>Patients from the data source National Health Databases, Denmark received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="B5">
          <title>Olodaterol - IMS RWE LPD General Practitioner (GP) Panel</title>
          <description>Patients from the data source IMS RWE LPD GP panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="B6">
          <title>Indacaterol - IMS RWE LPD GP Panel</title>
          <description>Patients from the data source IMS RWE LPD GP Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="B7">
          <title>Olodaterol - IMS RWE LPD Pulmonologist Panel</title>
          <description>Patients from the data source IMS RWE LPD pulmonologist panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="B8">
          <title>Indacaterol - IMS RWE LPD Pulmonologist Panel</title>
          <description>Patients from the data source IMS RWE LPD Pulmonologist Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1386"/>
            <count group_id="B2" value="1841"/>
            <count group_id="B3" value="1712"/>
            <count group_id="B4" value="6406"/>
            <count group_id="B5" value="696"/>
            <count group_id="B6" value="1592"/>
            <count group_id="B7" value="364"/>
            <count group_id="B8" value="127"/>
            <count group_id="B9" value="14124"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1386"/>
                    <count group_id="B2" value="1841"/>
                    <count group_id="B3" value="1712"/>
                    <count group_id="B4" value="6406"/>
                    <count group_id="B5" value="696"/>
                    <count group_id="B6" value="1592"/>
                    <count group_id="B7" value="364"/>
                    <count group_id="B8" value="127"/>
                    <count group_id="B9" value="14124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.9" spread="11.33"/>
                    <measurement group_id="B2" value="66.3" spread="12.83"/>
                    <measurement group_id="B3" value="70.6" spread="11.12"/>
                    <measurement group_id="B4" value="68.3" spread="11.45"/>
                    <measurement group_id="B5" value="62.5" spread="13.77"/>
                    <measurement group_id="B6" value="62.4" spread="14.40"/>
                    <measurement group_id="B7" value="65.8" spread="13.26"/>
                    <measurement group_id="B8" value="67.3" spread="13.39"/>
                    <measurement group_id="B9" value="67.2" spread="12.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1386"/>
                    <count group_id="B2" value="1841"/>
                    <count group_id="B3" value="1712"/>
                    <count group_id="B4" value="6406"/>
                    <count group_id="B5" value="696"/>
                    <count group_id="B6" value="1592"/>
                    <count group_id="B7" value="364"/>
                    <count group_id="B8" value="127"/>
                    <count group_id="B9" value="14124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="702"/>
                    <measurement group_id="B2" value="887"/>
                    <measurement group_id="B3" value="977"/>
                    <measurement group_id="B4" value="3324"/>
                    <measurement group_id="B5" value="322"/>
                    <measurement group_id="B6" value="696"/>
                    <measurement group_id="B7" value="129"/>
                    <measurement group_id="B8" value="42"/>
                    <measurement group_id="B9" value="7079"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="684"/>
                    <measurement group_id="B2" value="954"/>
                    <measurement group_id="B3" value="735"/>
                    <measurement group_id="B4" value="3082"/>
                    <measurement group_id="B5" value="374"/>
                    <measurement group_id="B6" value="896"/>
                    <measurement group_id="B7" value="235"/>
                    <measurement group_id="B8" value="85"/>
                    <measurement group_id="B9" value="7045"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="0"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="0"/>
                    <count group_id="B9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Off-label Use of Olodaterol Among New Users</title>
        <description>Percentage of off-label use of olodaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded Chronic Obstructive Pulmonary Disease (COPD) diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma. Index date is defined as the date an eligible patient receives the first dispensing of olodaterol or indacaterol during the study period.</description>
        <time_frame>01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.</time_frame>
        <population>Study population</population>
        <group_list>
          <group group_id="O1">
            <title>Olodaterol - PHARMO Overall</title>
            <description>Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Olodaterol - PHARMO-GP</title>
            <description>Patients from the data source PHARMO-GP received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Olodaterol - National Health Databases, Denmark</title>
            <description>Patients from the data source National Health Databases, Denmark received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Olodaterol - IMS RWE LPD General Practitioner (GP) Panel</title>
            <description>Patients from the data source IMS RWE LPD GP panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O5">
            <title>Olodaterol - IMS RWE LPD Pulmonologist Panel</title>
            <description>Patients from the data source IMS RWE LPD pulmonologist panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Off-label Use of Olodaterol Among New Users</title>
          <description>Percentage of off-label use of olodaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded Chronic Obstructive Pulmonary Disease (COPD) diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma. Index date is defined as the date an eligible patient receives the first dispensing of olodaterol or indacaterol during the study period.</description>
          <population>Study population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1386"/>
                <count group_id="O2" value="372"/>
                <count group_id="O3" value="1712"/>
                <count group_id="O4" value="696"/>
                <count group_id="O5" value="364"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Potential off-label</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.6"/>
                    <measurement group_id="O2" value="19.6"/>
                    <measurement group_id="O3" value="30.3"/>
                    <measurement group_id="O4" value="33.9"/>
                    <measurement group_id="O5" value="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Off-label</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5"/>
                    <measurement group_id="O2" value="6.2"/>
                    <measurement group_id="O3" value="4.4"/>
                    <measurement group_id="O4" value="12.4"/>
                    <measurement group_id="O5" value="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Off-label Use of Indacaterol Among New Users</title>
        <description>Percentage of off-label use of Indacaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded COPD diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma.</description>
        <time_frame>01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.</time_frame>
        <population>Study population</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol - PHARMO Overall</title>
            <description>Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol - PHARMO-GP</title>
            <description>Patients from the data source PHARMO-GP received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Indacaterol - National Health Databases, Denmark</title>
            <description>Patients from the data source National Health Databases, Denmark received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Indacaterol - IMS RWE LPD GP Panel</title>
            <description>Patients from the data source IMS RWE LPD GP Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O5">
            <title>Indacaterol - IMS RWE LPD Pulmonologist Panel</title>
            <description>Patients from the data source IMS RWE LPD Pulmonologist Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Off-label Use of Indacaterol Among New Users</title>
          <description>Percentage of off-label use of Indacaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded COPD diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma.</description>
          <population>Study population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1841"/>
                <count group_id="O2" value="636"/>
                <count group_id="O3" value="6406"/>
                <count group_id="O4" value="1592"/>
                <count group_id="O5" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Potential off-label</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.1"/>
                    <measurement group_id="O2" value="29.2"/>
                    <measurement group_id="O3" value="66.6"/>
                    <measurement group_id="O4" value="34.9"/>
                    <measurement group_id="O5" value="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Off-label</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5"/>
                    <measurement group_id="O2" value="6.8"/>
                    <measurement group_id="O3" value="4.6"/>
                    <measurement group_id="O4" value="11.9"/>
                    <measurement group_id="O5" value="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Characteristics of New Users of Indacaterol: Age</title>
        <description>Baseline characteristics of patients in treatment group by data source: Age</description>
        <time_frame>Baseline</time_frame>
        <population>Study population</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol - PHARMO Overall</title>
            <description>Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol - National Health Databases, Denmark</title>
            <description>Patients from the data source National Health Databases, Denmark received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Indacaterol - IMS RWE LPD GP Panel</title>
            <description>Patients from the data source IMS RWE LPD GP Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Indacaterol - IMS RWE LPD Pulmonologist Panel</title>
            <description>Patients from the data source IMS RWE LPD Pulmonologist Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Characteristics of New Users of Indacaterol: Age</title>
          <description>Baseline characteristics of patients in treatment group by data source: Age</description>
          <population>Study population</population>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1841"/>
                <count group_id="O2" value="6406"/>
                <count group_id="O3" value="1592"/>
                <count group_id="O4" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67" lower_limit="59.0" upper_limit="75.0"/>
                    <measurement group_id="O2" value="69" lower_limit="61.2" upper_limit="76.5"/>
                    <measurement group_id="O3" value="63" lower_limit="53.0" upper_limit="73.0"/>
                    <measurement group_id="O4" value="68" lower_limit="59.0" upper_limit="78.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Baseline Characteristics of New Users of Olodaterol: Age</title>
        <description>Baseline characteristics of patients in treatment group by data source: Age</description>
        <time_frame>Baseline</time_frame>
        <population>Study population</population>
        <group_list>
          <group group_id="O1">
            <title>Olodaterol - PHARMO Overall</title>
            <description>Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Olodaterol - National Health Databases, Denmark</title>
            <description>Patients from the data source National Health Databases, Denmark received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Olodaterol - IMS RWE LPD General Practitioner (GP) Panel</title>
            <description>Patients from the data source IMS RWE LPD GP panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Olodaterol - IMS RWE LPD Pulmonologist Panel</title>
            <description>Patients from the data source IMS RWE LPD pulmonologist panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Characteristics of New Users of Olodaterol: Age</title>
          <description>Baseline characteristics of patients in treatment group by data source: Age</description>
          <population>Study population</population>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1386"/>
                <count group_id="O2" value="1712"/>
                <count group_id="O3" value="696"/>
                <count group_id="O4" value="364"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68" lower_limit="60.0" upper_limit="75.0"/>
                    <measurement group_id="O2" value="71" lower_limit="64.0" upper_limit="78.5"/>
                    <measurement group_id="O3" value="63" lower_limit="53.0" upper_limit="72.0"/>
                    <measurement group_id="O4" value="67" lower_limit="59.0" upper_limit="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Baseline Characteristics of New Users of Olodaterol: Gender</title>
        <description>Baseline characteristics of patients in treatment group by data source: Gender</description>
        <time_frame>Baseline</time_frame>
        <population>Study population</population>
        <group_list>
          <group group_id="O1">
            <title>Olodaterol - PHARMO Overall</title>
            <description>Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Olodaterol - National Health Databases, Denmark</title>
            <description>Patients from the data source National Health Databases, Denmark received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Olodaterol - IMS RWE LPD General Practitioner (GP) Panel</title>
            <description>Patients from the data source IMS RWE LPD GP panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Olodaterol - IMS RWE LPD Pulmonologist Panel</title>
            <description>Patients from the data source IMS RWE LPD pulmonologist panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Characteristics of New Users of Olodaterol: Gender</title>
          <description>Baseline characteristics of patients in treatment group by data source: Gender</description>
          <population>Study population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1386"/>
                <count group_id="O2" value="1712"/>
                <count group_id="O3" value="696"/>
                <count group_id="O4" value="364"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="O1" value="702"/>
                    <measurement group_id="O2" value="977"/>
                    <measurement group_id="O3" value="322"/>
                    <measurement group_id="O4" value="129"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="O1" value="684"/>
                    <measurement group_id="O2" value="735"/>
                    <measurement group_id="O3" value="374"/>
                    <measurement group_id="O4" value="235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Characteristics of New Users of Indacaterol: Gender</title>
        <description>Baseline characteristics of patients in treatment group by data source: Gender</description>
        <time_frame>Baseline</time_frame>
        <population>Study population</population>
        <group_list>
          <group group_id="O1">
            <title>Indacaterol - PHARMO Overall</title>
            <description>Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O2">
            <title>Indacaterol - National Health Databases, Denmark</title>
            <description>Patients from the data source National Health Databases, Denmark received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O3">
            <title>Indacaterol - IMS RWE LPD GP Panel</title>
            <description>Patients from the data source IMS RWE LPD GP Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
          <group group_id="O4">
            <title>Indacaterol - IMS RWE LPD Pulmonologist Panel</title>
            <description>Patients from the data source IMS RWE LPD Pulmonologist Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Characteristics of New Users of Indacaterol: Gender</title>
          <description>Baseline characteristics of patients in treatment group by data source: Gender</description>
          <population>Study population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1841"/>
                <count group_id="O2" value="6406"/>
                <count group_id="O3" value="1592"/>
                <count group_id="O4" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="O1" value="887"/>
                    <measurement group_id="O2" value="3324"/>
                    <measurement group_id="O3" value="696"/>
                    <measurement group_id="O4" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="O1" value="954"/>
                    <measurement group_id="O2" value="3082"/>
                    <measurement group_id="O3" value="896"/>
                    <measurement group_id="O4" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Based on the data planned for this study, no suspected adverse events/reactions were expected.</time_frame>
      <desc>Adverse Events were not monitored/assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Olodaterol</title>
          <description>Patients initiating Olodaterol for the first time</description>
        </group>
        <group group_id="E2">
          <title>Indacaterol</title>
          <description>Patients initiating Indacaterol for the first time</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03030638
org study id: 1222.53
nct id: NCT03030638
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to characterise the use of single-agent olodaterol and single-agent
      indacaterol, the only marketed long-acting beta2-agonist (LABA)s authorised for chronic
      obstructive pulmonary disease (COPD), but not for asthma, in clinical practice.
Boehringer Ingelheim GmbH (BI) developed olodaterol, an inhaled long-acting beta2-agonist
      (LABA), for the indication of chronic obstructive pulmonary disease (COPD). Because the use
      of LABAs has been associated with increased morbidity and mortality in patients with asthma,
      the health authorities requested the conduct of a post-approval drug utilisation study to
      assess potential off-label use of olodaterol in asthma and to characterise the use of
      olodaterol in clinical practice. The single agent indacaterol, the only other marketed LABA
      authorised in clinical practice for COPD but not for asthma, will also be assessed. Study
      objectives include the following: (1) Quantify the frequency of off-label use of olodaterol
      and indacaterol among new users of these medications; and (2) Describe the baseline
      characteristics of new users of olodaterol and indacaterol. This cross-sectional study will
      use information among new users of olodaterol or indacaterol collected in the following
      healthcare databases: the PHARMO Database Network in the Netherlands, the National Registers
      in Denmark, and the IMS Health Information Solutions (IMS) Real-World Evidence (RWE)
      Longitudinal Patient Database (LPD) in France. The source population is all patients enrolled
      in the selected study databases at the date olodaterol became available in each database's
      country. The study groups are those patients from the source population who receive a first
      dispensing for single-agent formulations of olodaterol for the primary objective or
      indacaterol for the secondary objective and have at least 12 months of continuous enrolment
      in the study databases. The study will describe the number and proportion of new users by
      indication and potential off-label use and according to medical history and use of
      co-medications.
observational model: Cohort
time perspective: Cross-Sectional
measure: Percentage of Off-label Use of Olodaterol Among New Users
time frame: 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.
description: Percentage of off-label use of olodaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded Chronic Obstructive Pulmonary Disease (COPD) diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma. Index date is defined as the date an eligible patient receives the first dispensing of olodaterol or indacaterol during the study period.
measure: Baseline Characteristics of New Users of Olodaterol: Age
time frame: Baseline
description: Baseline characteristics of patients in treatment group by data source: Age
measure: Baseline Characteristics of New Users of Olodaterol: Gender
time frame: Baseline
description: Baseline characteristics of patients in treatment group by data source: Gender
measure: Percentage of Off-label Use of Indacaterol Among New Users
time frame: 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.
description: Percentage of off-label use of Indacaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded COPD diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma.
measure: Baseline Characteristics of New Users of Indacaterol: Age
time frame: Baseline
description: Baseline characteristics of patients in treatment group by data source: Age
measure: Baseline Characteristics of New Users of Indacaterol: Gender
time frame: Baseline
description: Baseline characteristics of patients in treatment group by data source: Gender
arm group label: Olodaterol
description: Patients initiating Olodaterol for the first time
arm group label: Indacaterol
description: Patients initiating Indacaterol for the first time
intervention type: Drug
intervention name: Olodaterol
description: Drug
arm group label: Olodaterol
other name: STRIVERDI
intervention type: Drug
intervention name: Indacaterol
description: Drug
arm group label: Indacaterol
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 28 Days
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
facility: 
facility: 
country: Denmark
country: France
country: Netherlands
url: http://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Olodaterol
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 