<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/NCT03003494</url>
  </required_header>
  <id_info>
    <org_study_id>1237.43</org_study_id>
    <nct_id>NCT03003494</nct_id>
  </id_info>
  <brief_title>Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy</brief_title>
  <acronym>OTIVACTO</acronym>
  <official_title>Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to measure changes in physical functioning in chronic obstructive&#xD;
      pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after approximately 6&#xD;
      weeks in routine clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2017</start_date>
  <completion_date type="Actual">July 30, 2018</completion_date>
  <primary_completion_date type="Actual">July 30, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)</measure>
    <time_frame>after approximately 6 weeks</time_frame>
    <description>Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome &quot;physical functioning&quot; is a sub-domain of the validated Short Form 36 (SF-36 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with &quot;yes, limited a lot&quot;, &quot;yes, limited a little&quot; or &quot;no, not limited at all&quot;, with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with &quot;yes, limited a lot&quot;) and 30 (a patient answering all questions with &quot;no, not limited at all&quot;). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: [(sum of scale items - 10) * 100] / 20. Higher scores indicate better physical functioning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2</measure>
    <time_frame>Baseline (visit 1) and after approx. week 6 (visit 2)</time_frame>
    <description>The change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the median for change from baseline values across all subjects was calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2</measure>
    <time_frame>Baseline (visit 1) and after approx.week 6 (visit 2)</time_frame>
    <description>The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Overall Satisfaction With Spiolto® Respimat®</measure>
    <time_frame>After approx. 6 weeks of treatment initiation</time_frame>
    <description>Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Inhaling From the Respimat® Device</measure>
    <time_frame>After approx. 6 weeks of treatment initiation</time_frame>
    <description>Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Handling of the Respimat® Inhalation Device</measure>
    <time_frame>After approx. 6 weeks of treatment initiation</time_frame>
    <description>Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">306</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Spiolto® Respimat®</arm_group_label>
    <description>consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Spiolto® Respimat®</intervention_name>
    <description>observations taken in a period of approximately 6 weeks</description>
    <arm_group_label>Spiolto® Respimat®</arm_group_label>
    <other_name>INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        400 chronic obstructive pulmonary disease (COPD) patients will be enrolled in Pulmonology&#xD;
        sites&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Written informed consent prior to participation&#xD;
&#xD;
          2. Female and male patients = 40 years of age&#xD;
&#xD;
          3. Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA +&#xD;
             LABA) treatment according to approved Spiolto® Respimat® SmPC and therapeutic plan&#xD;
             recommendation&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Patients with contraindications according to Spiolto® Respimat® Summary of Product&#xD;
             Characteristics (SmPC)&#xD;
&#xD;
          2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in&#xD;
             the previous 6 months&#xD;
&#xD;
          3. Patients continuing LABA-Inhalative Corticosteroids (ICS) treatment should not be&#xD;
             additionally treated with Spiolto® Respimat® in order to avoid a double dosing of&#xD;
             long-acting beta-agonists&#xD;
&#xD;
          4. Patients for whom further follow-up is not possible at the enrolling site during the&#xD;
             planned study period of approx. 6 weeks&#xD;
&#xD;
          5. Pregnancy and lactation&#xD;
&#xD;
          6. Patients currently listed for lung transplantation&#xD;
&#xD;
          7. Current participation in any clinical trial or any other non-interventional study of a&#xD;
             drug or device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</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>Ospedale Generale Regionale &quot;Miulli&quot;</name>
      <address>
        <city>Acquaviva Delle Fonti (BA)</city>
        <zip>70021</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera G. Rummo</name>
      <address>
        <city>Benevento</city>
        <zip>82100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casa di cura Mons. Calaciura</name>
      <address>
        <city>Biancavilla</city>
        <zip>95033</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Orlandi</name>
      <address>
        <city>Bussolengo (VR)</city>
        <zip>37012</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS - Istituto Scientifico di Cassano delle Murge</name>
      <address>
        <city>Cassano Murge Bari</city>
        <zip>70020</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi &quot;Magna Grecia&quot; - Campus &quot;S. Venuta&quot;</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Mellino Mellini</name>
      <address>
        <city>Chiari (BS)</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osp. Piero Palagi</name>
      <address>
        <city>Firenze</city>
        <zip>50125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Colonnello D Avanzo</name>
      <address>
        <city>Foggia</city>
        <zip>71100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Ospedale Guido Salvini</name>
      <address>
        <city>Garbagnate Milanese</city>
        <zip>20090</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero di Imperia - ASL 1 Imperiese</name>
      <address>
        <city>Imperia</city>
        <zip>18100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Salvatore</name>
      <address>
        <city>L'Aquila</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale della Versilia</name>
      <address>
        <city>LIDO DI Camaiore (LU)</city>
        <zip>55043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osp.dell'Angelo</name>
      <address>
        <city>Mestre</city>
        <zip>30171</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Centro San Raffaele del Monte Tabor</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Grande Ospedale Metropolitano Niguarda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osp. dei Colli Monaldi-Cotugno</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Ospedale S. Luigi Gonzaga</name>
      <address>
        <city>Orbassano</city>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S.Maria della Misericordia, AO di Perugia</name>
      <address>
        <city>Perugia</city>
        <zip>06156</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedali Riuniti Marche Nord</name>
      <address>
        <city>Pesaro</city>
        <zip>61100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az.per Assist. Sanitaria N.5 Friuli Occidentale</name>
      <address>
        <city>Pordenone</city>
        <zip>33170</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza</name>
      <address>
        <city>Roma</city>
        <zip>00189</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università di Salerno</name>
      <address>
        <city>Salerno</city>
        <zip>84121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero di Sesto S. Giovanni ASST Nord Milano</name>
      <address>
        <city>Sesto San Giovanni (MI)</city>
        <zip>20099</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Salvatore Maugeri</name>
      <address>
        <city>Tradate (VA)</city>
        <zip>21049</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Cattinara</name>
      <address>
        <city>Trieste</city>
        <zip>34149</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auxilium Vitae</name>
      <address>
        <city>Volterra</city>
        <zip>56048</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <results_first_submitted>July 29, 2019</results_first_submitted>
  <results_first_submitted_qc>September 27, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 30, 2019</results_first_posted>
  <last_update_submitted>September 27, 2019</last_update_submitted>
  <last_update_submitted_qc>September 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>July 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03003494/SAP_000.pdf</document_url>
    </provided_document>
    <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>July 13, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03003494/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patient with chronic Obstructive Pulmonary Disease receiving treatment Spiolto® Respimat® were enrolled between July 2017 and May 2018.&#xD;
309 screened and 3 patient violated inclusion/exclusion criteria were excluded, 306 entered the trial</recruitment_details>
      <pre_assignment_details>All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered if any one of the specific entry criteria were not met. Physical Functioning patient questionnaire (PF10)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Spiolto Respimat</title>
          <description>Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="306"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="278"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Evaluable PF10 questionnaire at visit1</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated set (TS): The Treated set comprising all patients with informed consent, registration date and at least one documented administration of Spiolto® Respimat®.</population>
      <group_list>
        <group group_id="B1">
          <title>Spiolto Respimat</title>
          <description>Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="306"/>
          </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="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.04" spread="8.81"/>
                  </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="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="216"/>
                  </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_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)</title>
        <description>Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome &quot;physical functioning&quot; is a sub-domain of the validated Short Form 36 (SF-36 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with &quot;yes, limited a lot&quot;, &quot;yes, limited a little&quot; or &quot;no, not limited at all&quot;, with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with &quot;yes, limited a lot&quot;) and 30 (a patient answering all questions with &quot;no, not limited at all&quot;). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: [(sum of scale items - 10) * 100] / 20. Higher scores indicate better physical functioning.</description>
        <time_frame>after approximately 6 weeks</time_frame>
        <population>Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed PF-10 questionnaire at both study visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Spiolto Respimat</title>
            <description>Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)</title>
          <description>Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome &quot;physical functioning&quot; is a sub-domain of the validated Short Form 36 (SF-36 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with &quot;yes, limited a lot&quot;, &quot;yes, limited a little&quot; or &quot;no, not limited at all&quot;, with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with &quot;yes, limited a lot&quot;) and 30 (a patient answering all questions with &quot;no, not limited at all&quot;). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: [(sum of scale items - 10) * 100] / 20. Higher scores indicate better physical functioning.</description>
          <population>Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed PF-10 questionnaire at both study visits.</population>
          <units>Percentage of Participants (%)</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.52" lower_limit="46.47" upper_limit="58.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2</title>
        <description>The change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the median for change from baseline values across all subjects was calculated.</description>
        <time_frame>Baseline (visit 1) and after approx. week 6 (visit 2)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Spiolto Respimat</title>
            <description>Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines</description>
          </group>
        </group_list>
        <measure>
          <title>The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2</title>
          <description>The change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the median for change from baseline values across all subjects was calculated.</description>
          <population>FAS</population>
          <units>Unit on scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="-60" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2</title>
        <description>The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent</description>
        <time_frame>Baseline (visit 1) and after approx.week 6 (visit 2)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Spiolto Respimat</title>
            <description>Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines</description>
          </group>
        </group_list>
        <measure>
          <title>Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2</title>
          <description>The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent</description>
          <population>FAS</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="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Visit 1) : PGE score 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Visit 1) : PGE score 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Visit 1) : PGE score 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Visit 1) : PGE score 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Visit 1) : PGE score 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Visit 1) : PGE score 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Visit 1) : PGE score 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Visit 1) : PGE score 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (approx.) (Visit 2): Score 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (approx.) (Visit 2): Score 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (approx.) (Visit 2): Score 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (approx.) (Visit 2): Score 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (approx.) (Visit 2): Score 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (approx.) (Visit 2): Score 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (approx.) (Visit 2): Score 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (approx.) (Visit 2): Score 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Overall Satisfaction With Spiolto® Respimat®</title>
        <description>Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2).</description>
        <time_frame>After approx. 6 weeks of treatment initiation</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Spiolto Respimat</title>
            <description>Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Overall Satisfaction With Spiolto® Respimat®</title>
          <description>Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2).</description>
          <population>FAS</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="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rather satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither satisfied nor dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rather dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Questionnaire not completed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Inhaling From the Respimat® Device</title>
        <description>Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2)</description>
        <time_frame>After approx. 6 weeks of treatment initiation</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Spiolto Respimat</title>
            <description>Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Inhaling From the Respimat® Device</title>
          <description>Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2)</description>
          <population>FAS</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="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rather satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither satisfied nor dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rather dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Questionnaire not completed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Handling of the Respimat® Inhalation Device</title>
        <description>Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2).</description>
        <time_frame>After approx. 6 weeks of treatment initiation</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Spiolto Respimat</title>
            <description>Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Handling of the Respimat® Inhalation Device</title>
          <description>Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2).</description>
          <population>FAS</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="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rather satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither satisfied nor dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rather dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Questionnaire not completed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first drug administration until end of study, up to approx 6 weeks.</time_frame>
      <desc>All safety analyses were based on the TS</desc>
      <group_list>
        <group group_id="E1">
          <title>Spiolto Respimat</title>
          <description>Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="306"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="306"/>
              </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="306"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Therapeutic success was assessed by a patient questionnaire at two time points. The respective answers were dependent on the condition of the patient at the completion. No objective assessment was performed due to the non-interventional study concept</limitations_and_caveats>
    <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/NCT03003494
org study id: 1237.43
nct id: NCT03003494
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of the study is to measure changes in physical functioning in chronic obstructive
      pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after approximately 6
      weeks in routine clinical practice.
Purpose:
observational model: Cohort
time perspective: Prospective
measure: Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)
time frame: after approximately 6 weeks
description: Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome "physical functioning" is a sub-domain of the validated Short Form 36 (SF-36 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little" or "no, not limited at all", with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "no, not limited at all"). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: [(sum of scale items - 10) * 100] / 20. Higher scores indicate better physical functioning.
measure: The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2
time frame: Baseline (visit 1) and after approx. week 6 (visit 2)
description: The change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the median for change from baseline values across all subjects was calculated.
measure: Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2
time frame: Baseline (visit 1) and after approx.week 6 (visit 2)
description: The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent
measure: Patient Overall Satisfaction With Spiolto® Respimat®
time frame: After approx. 6 weeks of treatment initiation
description: Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2).
measure: Patient Satisfaction With Inhaling From the Respimat® Device
time frame: After approx. 6 weeks of treatment initiation
description: Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2)
measure: Patient Satisfaction With Handling of the Respimat® Inhalation Device
time frame: After approx. 6 weeks of treatment initiation
description: Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2).
arm group label: Spiolto® Respimat®
description: consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC
intervention type: Drug
intervention name: Spiolto® Respimat®
description: observations taken in a period of approximately 6 weeks
arm group label: Spiolto® Respimat®
other name: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
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country: Italy
url: http://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: Undecided
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limitations and caveats: Therapeutic success was assessed by a patient questionnaire at two time points. The respective answers were dependent on the condition of the patient at the completion. No objective assessment was performed due to the non-interventional study concept
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