<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/NCT01708057</url>
  </required_header>
  <id_info>
    <org_study_id>D1883C00007</org_study_id>
    <secondary_id>EudraCT number: 2012-002900-42</secondary_id>
    <nct_id>NCT01708057</nct_id>
  </id_info>
  <brief_title>A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients</brief_title>
  <official_title>A Randomised, Double-blind Placebo- and Active-controlled, Multi-centre, 6-way Cross-over, Single-dose Phase IIa Study to Investigate the Bronchodilatory and Systemic Effects of 4 Different Doses of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <brief_summary>
    <textblock>
      This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the&#xD;
      bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active&#xD;
      comparator.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over,&#xD;
      single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4&#xD;
      different doses of inhaled AZD8683 in patients with Chronic Obstructive Pulmonary Disease&#xD;
      (COPD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Peak FEV1 (0-24h)</measure>
    <time_frame>The first 24 hours following dose administration</time_frame>
    <description>The maximum value over 24 hours post-dose, as change from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Trough FEV1 (22-26h)</measure>
    <time_frame>22 to 26 hours following dose administration</time_frame>
    <description>The average over 22 to 26 hours, as change from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average FEV1 as a Change From Baseline</measure>
    <time_frame>The first 24 hours following dose administration</time_frame>
    <description>Average FEV1 (0-24h): The average over 0 to 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Increase in Systolic Blood Pressure [SBP]</measure>
    <time_frame>baseline, 24hr post dose</time_frame>
    <description>Maximum (post-dose values - baseline value) for each treatment visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Increase in Diastolic Blood Pressure [DBP]</measure>
    <time_frame>The first 24 hours following dose administration</time_frame>
    <description>Maximum (post-dose values - baseline value) for each treatment visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Increase Heart Rate [HR]</measure>
    <time_frame>baseline, 24hr post dose</time_frame>
    <description>Maximum (post-dose values - baseline value) for each treatment visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Increase in QTcF</measure>
    <time_frame>baseline, 24hr post dose</time_frame>
    <description>maximum (post-dose values - baseline value) for each treatment visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameters (AZD8683)</measure>
    <time_frame>Pre-dose, 24hr post-dose</time_frame>
    <description>Cmax, tmax, AUC</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of AZD8683 50 µg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of AZD8683 150 µg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of AZD8683 300 µg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of AZD8683 900 µg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose of placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of tiotropium 18 µg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD8683</intervention_name>
    <description>AZD8683 administered via inhalation</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
    <arm_group_label>3</arm_group_label>
    <arm_group_label>4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo administered via inhalation</description>
    <arm_group_label>5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tiotropium</intervention_name>
    <description>Tiotropium administered via inhalation</description>
    <arm_group_label>6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of informed consent prior to any study specific procedures Male or female,&#xD;
             age ≥ 40 years at Visit 1. Women must be of non-childbearing potential or must have&#xD;
             been stable on a highly effective contraceptive method for at least 3 months prior to&#xD;
             Visit 1 and be willing to continue until follow-up&#xD;
&#xD;
          -  Clinical diagnosis of COPD for more than 1 year at Visit 1&#xD;
&#xD;
          -  FEV1 ≥ 30 to &lt; 80% of the predicted normal value (post-bronchodilator) at Visit 2 and&#xD;
             post-bronchodilator FEV1/FVC &lt; 70%&#xD;
&#xD;
          -  Reversible airway obstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant disease or disorder which, in the opinion of the Investigator, may either&#xD;
             put the patient at risk because of participation in the study, or influence the result&#xD;
             of the study, or the patient's ability to participate in the study.&#xD;
&#xD;
          -  An exacerbation of COPD (defined as use of oral/parenteral glucocorticosteroids (GCS)&#xD;
             and/or antibiotics and/or hospitalisation related to COPD) within 6 weeks of Visit 1or&#xD;
             during the enrolment period&#xD;
&#xD;
          -  Treatment with systemic GCS within 6 weeks of Visit 2 or during the enrolment period&#xD;
&#xD;
          -  Respiratory tract infection of clinical relevance within 30 days of Visit 4, as judged&#xD;
             by the Investigator&#xD;
&#xD;
          -  Long-term oxygen therapy, as judged by the Investigator&#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>Carin Jorup, MD</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca R&amp;DMolndal, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Proszowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <results_first_submitted>July 30, 2013</results_first_submitted>
  <results_first_submitted_qc>July 30, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 30, 2013</results_first_posted>
  <last_update_submitted>December 13, 2013</last_update_submitted>
  <last_update_submitted_qc>December 13, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Chronic obstructive pulmonary disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <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>Tiotropium Bromide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 14 subjects were enrolled. Of these, 3 subjects were randomized to receive a treatment sequence consisting of 6 different treatments in random order. The study was terminated prematurely, hence only one period out of six planned was performed.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>AFBECD</title>
          <description>AZD8683 50 ug followed by Placebo followed by AZD8683 150 ug followed by Spiriva® 18 ug followed by AZD8683 300 ug followed by AZD8683 900 ug</description>
        </group>
        <group group_id="P2">
          <title>FEADBC</title>
          <description>Placebo followed by Spiriva® 18 ug followed by AZD8683 50 ug followed by AZD8683 900 ug followed by AZD8683 150 ug followed by AZD8683 300 ug</description>
        </group>
        <group group_id="P3">
          <title>DCEBFA</title>
          <description>AZD8683 900 ug followed by AZD8683 300 ug followed by Spiriva® 18 ug followed by AZD8683 150 ug followed by Placebo followed by AZD8683 50 ug</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal due to study termination.</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Total Baseline</title>
          <description>All Patients population</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;=18 year</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 18 and 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Peak FEV1 (0-24h)</title>
        <description>The maximum value over 24 hours post-dose, as change from baseline</description>
        <time_frame>The first 24 hours following dose administration</time_frame>
        <population>As the study was terminated prematurely none of the randomised patients have been analysed.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8683 150 ug</title>
            <description>AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O2">
            <title>AZD8683 300ug</title>
            <description>AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O3">
            <title>AZD8683 900ug</title>
            <description>AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler</description>
          </group>
          <group group_id="O4">
            <title>Spiriva 18 ug</title>
            <description>Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®</description>
          </group>
          <group group_id="O6">
            <title>AZD8683 50ug</title>
            <description>AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Peak FEV1 (0-24h)</title>
          <description>The maximum value over 24 hours post-dose, as change from baseline</description>
          <population>As the study was terminated prematurely none of the randomised patients have been analysed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Trough FEV1 (22-26h)</title>
        <description>The average over 22 to 26 hours, as change from baseline</description>
        <time_frame>22 to 26 hours following dose administration</time_frame>
        <population>As the study was terminated prematurely none of the randomized patients have been analysed.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8683 150 ug</title>
            <description>AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O2">
            <title>AZD8683 300ug</title>
            <description>AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O3">
            <title>AZD8683 900ug</title>
            <description>AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler</description>
          </group>
          <group group_id="O4">
            <title>Spiriva 18 ug</title>
            <description>Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®</description>
          </group>
          <group group_id="O6">
            <title>AZD8683 50ug</title>
            <description>AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Trough FEV1 (22-26h)</title>
          <description>The average over 22 to 26 hours, as change from baseline</description>
          <population>As the study was terminated prematurely none of the randomized patients have been analysed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average FEV1 as a Change From Baseline</title>
        <description>Average FEV1 (0-24h): The average over 0 to 24 hours</description>
        <time_frame>The first 24 hours following dose administration</time_frame>
        <population>As the study was terminated prematurely none of the randomized patients have been analysed.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8683 150 ug</title>
            <description>AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O2">
            <title>AZD8683 300ug</title>
            <description>AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O3">
            <title>AZD8683 900ug</title>
            <description>AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler</description>
          </group>
          <group group_id="O4">
            <title>Spiriva 18 ug</title>
            <description>Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®</description>
          </group>
          <group group_id="O6">
            <title>AZD8683 50ug</title>
            <description>AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
        </group_list>
        <measure>
          <title>Average FEV1 as a Change From Baseline</title>
          <description>Average FEV1 (0-24h): The average over 0 to 24 hours</description>
          <population>As the study was terminated prematurely none of the randomized patients have been analysed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Increase in Systolic Blood Pressure [SBP]</title>
        <description>Maximum (post-dose values - baseline value) for each treatment visit.</description>
        <time_frame>baseline, 24hr post dose</time_frame>
        <population>As the study was terminated prematurely none of the randomised patients have bean analysed.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8683 150 ug</title>
            <description>AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O2">
            <title>AZD8683 300ug</title>
            <description>AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O3">
            <title>AZD8683 900ug</title>
            <description>AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler</description>
          </group>
          <group group_id="O4">
            <title>Spiriva 18 ug</title>
            <description>Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®</description>
          </group>
          <group group_id="O6">
            <title>AZD8683 50ug</title>
            <description>AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Increase in Systolic Blood Pressure [SBP]</title>
          <description>Maximum (post-dose values - baseline value) for each treatment visit.</description>
          <population>As the study was terminated prematurely none of the randomised patients have bean analysed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Increase in Diastolic Blood Pressure [DBP]</title>
        <description>Maximum (post-dose values - baseline value) for each treatment visit.</description>
        <time_frame>The first 24 hours following dose administration</time_frame>
        <population>As the study was terminated prematurely none of the randomised patients have bean analysed.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8683 150 ug</title>
            <description>AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O2">
            <title>AZD8683 300ug</title>
            <description>AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O3">
            <title>AZD8683 900ug</title>
            <description>AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler</description>
          </group>
          <group group_id="O4">
            <title>Spiriva 18 ug</title>
            <description>Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®</description>
          </group>
          <group group_id="O6">
            <title>AZD8683 50ug</title>
            <description>AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Increase in Diastolic Blood Pressure [DBP]</title>
          <description>Maximum (post-dose values - baseline value) for each treatment visit.</description>
          <population>As the study was terminated prematurely none of the randomised patients have bean analysed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Increase Heart Rate [HR]</title>
        <description>Maximum (post-dose values - baseline value) for each treatment visit.</description>
        <time_frame>baseline, 24hr post dose</time_frame>
        <population>As the study was terminated prematurely none of the randomised patients have bean analysed.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8683 150 ug</title>
            <description>AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O2">
            <title>AZD8683 300ug</title>
            <description>AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O3">
            <title>AZD8683 900ug</title>
            <description>AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler</description>
          </group>
          <group group_id="O4">
            <title>Spiriva 18 ug</title>
            <description>Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®</description>
          </group>
          <group group_id="O6">
            <title>AZD8683 50ug</title>
            <description>AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Increase Heart Rate [HR]</title>
          <description>Maximum (post-dose values - baseline value) for each treatment visit.</description>
          <population>As the study was terminated prematurely none of the randomised patients have bean analysed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Increase in QTcF</title>
        <description>maximum (post-dose values - baseline value) for each treatment visit.</description>
        <time_frame>baseline, 24hr post dose</time_frame>
        <population>As the study was terminated prematurely none of the randomised patients have bean analysed.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8683 150 ug</title>
            <description>AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O2">
            <title>AZD8683 300ug</title>
            <description>AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O3">
            <title>AZD8683 900ug</title>
            <description>AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler</description>
          </group>
          <group group_id="O4">
            <title>Spiriva 18 ug</title>
            <description>Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®</description>
          </group>
          <group group_id="O6">
            <title>AZD8683 50ug</title>
            <description>AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Increase in QTcF</title>
          <description>maximum (post-dose values - baseline value) for each treatment visit.</description>
          <population>As the study was terminated prematurely none of the randomised patients have bean analysed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameters (AZD8683)</title>
        <description>Cmax, tmax, AUC</description>
        <time_frame>Pre-dose, 24hr post-dose</time_frame>
        <population>As the study was terminated prematurely none of the randomised patients have bean analysed.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD8683 150 ug</title>
            <description>AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O2">
            <title>AZD8683 300ug</title>
            <description>AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
          <group group_id="O3">
            <title>AZD8683 900ug</title>
            <description>AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler</description>
          </group>
          <group group_id="O4">
            <title>Spiriva 18 ug</title>
            <description>Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg</description>
          </group>
          <group group_id="O5">
            <title>Placebo</title>
            <description>Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®</description>
          </group>
          <group group_id="O6">
            <title>AZD8683 50ug</title>
            <description>AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameters (AZD8683)</title>
          <description>Cmax, tmax, AUC</description>
          <population>As the study was terminated prematurely none of the randomised patients have bean analysed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>21 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>50ug AZD8683</title>
          <description>AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
        </group>
        <group group_id="E2">
          <title>150 ug AZD8683</title>
          <description>AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
        </group>
        <group group_id="E3">
          <title>300 ug AZD8683</title>
          <description>AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva</description>
        </group>
        <group group_id="E4">
          <title>900 ug AZD8683</title>
          <description>AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler;</description>
        </group>
        <group group_id="E5">
          <title>18ug Spiriva</title>
          <description>Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg</description>
        </group>
        <group group_id="E6">
          <title>Placebo</title>
          <description>Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA version 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Carin Jorup</name_or_title>
      <organization>AstraZeneca</organization>
      <email>aztrial_results_posting@astrazeneca.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/NCT01708057
org study id: D1883C00007
secondary id: EudraCT number: 2012-002900-42
nct id: NCT01708057
lead sponsor: 
This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the
      bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active
      comparator.
A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over,
      single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4
      different doses of inhaled AZD8683 in patients with Chronic Obstructive Pulmonary Disease
      (COPD).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Peak FEV1 (0-24h)
time frame: The first 24 hours following dose administration
description: The maximum value over 24 hours post-dose, as change from baseline
measure: Change From Baseline in Trough FEV1 (22-26h)
time frame: 22 to 26 hours following dose administration
description: The average over 22 to 26 hours, as change from baseline
measure: Average FEV1 as a Change From Baseline
time frame: The first 24 hours following dose administration
description: Average FEV1 (0-24h): The average over 0 to 24 hours
measure: Maximum Increase in Systolic Blood Pressure [SBP]
time frame: baseline, 24hr post dose
description: Maximum (post-dose values - baseline value) for each treatment visit.
measure: Maximum Increase in Diastolic Blood Pressure [DBP]
time frame: The first 24 hours following dose administration
description: Maximum (post-dose values - baseline value) for each treatment visit.
measure: Maximum Increase Heart Rate [HR]
time frame: baseline, 24hr post dose
description: Maximum (post-dose values - baseline value) for each treatment visit.
measure: Maximum Increase in QTcF
time frame: baseline, 24hr post dose
description: maximum (post-dose values - baseline value) for each treatment visit.
measure: PK Parameters (AZD8683)
time frame: Pre-dose, 24hr post-dose
description: Cmax, tmax, AUC
arm group label: 1
arm group type: Experimental
description: Single dose of AZD8683 50 µg
arm group label: 2
arm group type: Experimental
description: Single dose of AZD8683 150 µg
arm group label: 3
arm group type: Experimental
description: Single dose of AZD8683 300 µg
arm group label: 4
arm group type: Experimental
description: Single dose of AZD8683 900 µg
arm group label: 5
arm group type: Placebo Comparator
description: Single dose of placebo
arm group label: 6
arm group type: Active Comparator
description: Single dose of tiotropium 18 µg
intervention type: Drug
intervention name: AZD8683
description: AZD8683 administered via inhalation
arm group label: 1
arm group label: 2
arm group label: 3
arm group label: 4
intervention type: Drug
intervention name: Placebo
description: Placebo administered via inhalation
arm group label: 5
intervention type: Drug
intervention name: Tiotropium
description: Tiotropium administered via inhalation
arm group label: 6
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Carin Jorup, MD
role: Study Director
affiliation: AstraZeneca R&DMolndal, Sweden
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Poland
country: Sweden
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Tiotropium Bromide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 