<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/NCT03262012</url>
  </required_header>
  <id_info>
    <org_study_id>PT010007</org_study_id>
    <nct_id>NCT03262012</nct_id>
  </id_info>
  <brief_title>Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With COPD Compared With Symbicort® Turbohaler®</brief_title>
  <official_title>A Randomized, Double-Blind, Parallel-Group, 28-Week, Chronic-Dosing, Multi-Center, Extension Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) Compared With Symbicort® Turbuhaler® as an Active Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pearl Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pearl Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term&#xD;
      Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very&#xD;
      Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, randomized, double-blind, parallel group, chronic dosing,&#xD;
      active-controlled, 28-week, safety extension of Study PT010006 to assess the safety and&#xD;
      efficacy of BGF MDI, GFF MDI, BFF MDI, and Symbicort TBH as an active control over a 52-week&#xD;
      period in Japanese subjects with moderate to very severe COPD who remain symptomatic on&#xD;
      maintenance treatment with either an ICS and one or more bronchodilator(s) or two or more&#xD;
      maintenance bronchodilators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2016</start_date>
  <completion_date type="Actual">June 15, 2018</completion_date>
  <primary_completion_date type="Actual">June 15, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values</measure>
    <time_frame>28 Weeks</time_frame>
    <description>Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs</measure>
    <time_frame>28 Weeks</time_frame>
    <description>Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values</measure>
    <time_frame>28 Weeks</time_frame>
    <description>Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">416</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>BGF MDI (PT010)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GFF MDI (PT003)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BFF MDI (PT009)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Symbicort® Turbohaler® Inhalation Powder</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BGF MDI (PT010)</intervention_name>
    <description>Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010</description>
    <arm_group_label>BGF MDI (PT010)</arm_group_label>
    <other_name>BGF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GFF MDI (PT003)</intervention_name>
    <description>Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003</description>
    <arm_group_label>GFF MDI (PT003)</arm_group_label>
    <other_name>GFF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BFF MDI (PT009)</intervention_name>
    <description>Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009</description>
    <arm_group_label>BFF MDI (PT009)</arm_group_label>
    <other_name>BFF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Symbicort® Turbohaler® Inhalation Powder</intervention_name>
    <description>Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler</description>
    <arm_group_label>Symbicort® Turbohaler® Inhalation Powder</arm_group_label>
    <other_name>Symbicort</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Given their signed written informed consent to participate.&#xD;
&#xD;
          -  Subjects must have agreed to participate and complete the lead-in Study PT010006.&#xD;
&#xD;
          -  Non-child bearing potential (ie, physiologically incapable of becoming pregnant,&#xD;
             including any female who is 2 years post-menopausal); or Child bearing potential, has&#xD;
             a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive&#xD;
             methods used consistently and correctly for the duration of the study.&#xD;
&#xD;
          -  Subjects with an established clinical history of COPD as defined by the American&#xD;
             Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable&#xD;
             guidelines.&#xD;
&#xD;
          -  Current or former smokers with a history of at least 10 pack-years of cigarette&#xD;
             smoking.&#xD;
&#xD;
          -  Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be&#xD;
             &lt;0.70 and FEV1 must be &lt;80% predicted normal value calculated using NHANES III&#xD;
             reference equations (or reference norms applicable to other regions).&#xD;
&#xD;
          -  Required COPD maintenance therapy:&#xD;
&#xD;
          -  All Subjects must have been on two or more inhaled maintenance therapies for the&#xD;
             management of their COPD for at least 6 weeks prior to Screening. Scheduled SABA&#xD;
             and/or scheduled SAMA are considered inhaled maintenance therapies.&#xD;
&#xD;
        Please refer to the study protocol for the complete inclusion criteria list.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Significant diseases or conditions other than COPD, which, in the opinion of the&#xD;
             Investigator, may put the subject at risk because of participation in the study or may&#xD;
             influence either the results of the study or the subject's ability to participate in&#xD;
             the study.&#xD;
&#xD;
          -  Women who are pregnant or lactating, or are planning to become pregnant during the&#xD;
             course of the study, or women of childbearing potential who are not using an&#xD;
             acceptable method of contraception.&#xD;
&#xD;
          -  Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.&#xD;
&#xD;
          -  Subjects who have been hospitalized due to poorly controlled COPD within 3 months&#xD;
             prior to Visit 1 (Screening) or during the Screening Period&#xD;
&#xD;
          -  Subjects who have poorly controlled COPD, defined as acute worsening of COPD that&#xD;
             requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to&#xD;
             Visit 1 (Screening) or during the Screening Period&#xD;
&#xD;
          -  Immune suppression or severe neurological disorders affecting control of the upper&#xD;
             airway or other risk factors that in the opinion of the Investigator would put the&#xD;
             subject at substantial risk of pneumonia.&#xD;
&#xD;
          -  Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the&#xD;
             Investigator, have not been adequately treated.&#xD;
&#xD;
          -  Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any&#xD;
             other corticosteroid components, glycopyrronium or other muscarinic anticholinergics,&#xD;
             or any other component of the IMPs.&#xD;
&#xD;
        Please refer to the study protocol for the complete exclusion criteria list.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul M. Dorinsky, MD</last_name>
    <role>Study Director</role>
    <affiliation>Pearl Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bunkyo-ku</city>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chuo-ku</city>
        <zip>103-0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chuo-ku</city>
        <zip>104-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chuo-ku</city>
        <zip>104-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Date-gun</city>
        <zip>969-1793</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukuoka-shi</city>
        <zip>814-0180</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ginowan-shi</city>
        <zip>901-2214</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hakata-shi</city>
        <zip>812-0033</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hamamatsu-shi</city>
        <zip>430-0906</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hamamatsu-shi</city>
        <zip>430-8525</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hamamatsu-shi</city>
        <zip>434-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Higashiokitama-gun</city>
        <zip>992-0601</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Higashiosaka-shi</city>
        <zip>577-0843</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Himeji-shi</city>
        <zip>672-8064</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hirakata-shi</city>
        <zip>573-1191</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iizuka-shi</city>
        <zip>820-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Itabashi-ku</city>
        <zip>173-8610</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iwata-shi</city>
        <zip>438-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Izumo-shi</city>
        <zip>693-0068</zip>
        <country>Japan</country>
      </address>
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  <location>
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        <zip>693-8501</zip>
        <country>Japan</country>
      </address>
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      <name>Research Site</name>
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        <city>Kagoshima-shi</city>
        <zip>892-0847</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kahoku-gun</city>
        <zip>920-0293</zip>
        <country>Japan</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kakogawa-shi</city>
        <zip>675-0023</zip>
        <country>Japan</country>
      </address>
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  <location>
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      <name>Research Site</name>
      <address>
        <city>Kasaoka-shi</city>
        <zip>714-0081</zip>
        <country>Japan</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kasuga-shi</city>
        <zip>816-0813</zip>
        <country>Japan</country>
      </address>
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  <location>
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      <name>Research Site</name>
      <address>
        <city>Kishiwada-shi</city>
        <zip>596-8501</zip>
        <country>Japan</country>
      </address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kiyose-shi</city>
        <zip>204-0023</zip>
        <country>Japan</country>
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      <name>Research Site</name>
      <address>
        <city>Kobe-shi</city>
        <zip>650-0017</zip>
        <country>Japan</country>
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      <name>Research Site</name>
      <address>
        <city>Koga-shi</city>
        <zip>811-3195</zip>
        <country>Japan</country>
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      <address>
        <city>Kurashiki-shi</city>
        <zip>711-0921</zip>
        <country>Japan</country>
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        <zip>737-0193</zip>
        <country>Japan</country>
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    <facility>
      <name>Research Site</name>
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        <zip>737-8505</zip>
        <country>Japan</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyoto-shi</city>
        <zip>601-1495</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyoto-shi</city>
        <zip>601-8206</zip>
        <country>Japan</country>
      </address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyoto-shi</city>
        <zip>602-8026</zip>
        <country>Japan</country>
      </address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyoto-shi</city>
        <zip>607-8062</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyoto-shi</city>
        <zip>615-8087</zip>
        <country>Japan</country>
      </address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Maebashi-shi</city>
        <zip>371-0054</zip>
        <country>Japan</country>
      </address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Matsumoto-shi</city>
        <zip>390-0872</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Matsusaka-shi</city>
        <zip>515-0073</zip>
        <country>Japan</country>
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    <facility>
      <name>Research Site</name>
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        <city>Meguro-ku</city>
        <zip>153-8515</zip>
        <country>Japan</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Mitaka-shi</city>
        <zip>181-8611</zip>
        <country>Japan</country>
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      <address>
        <city>Mizunami-shi</city>
        <zip>509-6134</zip>
        <country>Japan</country>
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        <city>Nagaoka-shi</city>
        <zip>940-2085</zip>
        <country>Japan</country>
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        <zip>454-8502</zip>
        <country>Japan</country>
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    <facility>
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        <country>Japan</country>
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      <address>
        <city>Naha-shi</city>
        <zip>902-0061</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nishishirakawa-gun</city>
        <zip>969-0213</zip>
        <country>Japan</country>
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  <location>
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      <address>
        <city>Obihiro-shi</city>
        <zip>080-0013</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ogaki-shi</city>
        <zip>503-8502</zip>
        <country>Japan</country>
      </address>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Oita-shi</city>
        <zip>870-0921</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oita-shi</city>
        <zip>870-0951</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Okinawa-shi</city>
        <zip>904-2143</zip>
        <country>Japan</country>
      </address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ookawa-shi</city>
        <zip>831-0016</zip>
        <country>Japan</country>
      </address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Osaka-shi</city>
        <zip>543-0035</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Osakasayama-shi</city>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Otsu-shi</city>
        <zip>520-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sakai-shi</city>
        <zip>591-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sakaide-shi</city>
        <zip>762-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sapporo-shi</city>
        <zip>001-0901</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sapporo-shi</city>
        <zip>064-0915</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sendai-shi</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sendai-shi</city>
        <zip>983-0824</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sendai-shi</city>
        <zip>984-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seto-shi</city>
        <zip>489-8642</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shinagawa-ku</city>
        <zip>142-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shinjuku-ku</city>
        <zip>162-0052</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shizuoka-shi</city>
        <zip>420-8630</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Suita-shi</city>
        <zip>564-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tachikawa-shi</city>
        <zip>190-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Takamatsu-shi</city>
        <zip>760-8538</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toon-shi</city>
        <zip>791-0281</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toshima-ku</city>
        <zip>171-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toyama-shi</city>
        <zip>930-0194</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toyama-shi</city>
        <zip>931-8533</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toyama-shi</city>
        <zip>939-8282</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yanagawa-shi</city>
        <zip>832-0059</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yokohama-shi</city>
        <zip>236-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>February 17, 2016</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <results_first_submitted>March 27, 2020</results_first_submitted>
  <results_first_submitted_qc>May 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 13, 2020</results_first_posted>
  <disposition_first_submitted>March 27, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>April 4, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 10, 2019</disposition_first_posted>
  <last_update_submitted>May 1, 2020</last_update_submitted>
  <last_update_submitted_qc>May 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budesonide, Formoterol Fumarate Drug Combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03262012/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03262012/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at 75 study centers in Japan, from Aug 2016 to June 2018. This is an extension study of PT010006 and could take up to an additional 28 weeks.</recruitment_details>
      <pre_assignment_details>Subjects were randomized in a 2:2:1:1 scheme.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>BGF MDI 320/14.4/9.6 ug</title>
          <description>Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug</description>
        </group>
        <group group_id="P2">
          <title>GFF MDI 14.4/9.6 ug</title>
          <description>Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug</description>
        </group>
        <group group_id="P3">
          <title>BFF MDI 320/9.6 ug</title>
          <description>Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug</description>
        </group>
        <group group_id="P4">
          <title>Symbicort TBH 400/12 ug BID</title>
          <description>Open Label Symbicort Turbuhaler 400/12 ug BID</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="139"/>
                <participants group_id="P2" count="138"/>
                <participants group_id="P3" count="70"/>
                <participants group_id="P4" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
                <participants group_id="P2" count="102"/>
                <participants group_id="P3" count="56"/>
                <participants group_id="P4" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Discontinuation Criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Japanese Safety Population</population>
      <group_list>
        <group group_id="B1">
          <title>BGF MDI 320/14.4/9.6 ug</title>
          <description>Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug</description>
        </group>
        <group group_id="B2">
          <title>GFF MDI 14.4/9.6 ug</title>
          <description>Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug</description>
        </group>
        <group group_id="B3">
          <title>BFF MDI 320/9.6 ug</title>
          <description>Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug</description>
        </group>
        <group group_id="B4">
          <title>Symbicort TBH 400/12 ug BID</title>
          <description>Open Label Symbicort Turbuhaler 400/12 ug BID</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="139"/>
            <count group_id="B2" value="138"/>
            <count group_id="B3" value="70"/>
            <count group_id="B4" value="69"/>
            <count group_id="B5" value="416"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Japanese Safety Population</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.4" spread="7.1"/>
                    <measurement group_id="B2" value="69.0" spread="6.1"/>
                    <measurement group_id="B3" value="69.7" spread="6.1"/>
                    <measurement group_id="B4" value="70.1" spread="6.8"/>
                    <measurement group_id="B5" value="69.5" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Japanese Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="68"/>
                    <measurement group_id="B5" value="392"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>Japanese subjects randomized</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="139"/>
                    <measurement group_id="B2" value="138"/>
                    <measurement group_id="B3" value="69"/>
                    <measurement group_id="B4" value="69"/>
                    <measurement group_id="B5" value="415"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>Japanese subjects randomized</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="139"/>
                    <measurement group_id="B2" value="138"/>
                    <measurement group_id="B3" value="70"/>
                    <measurement group_id="B4" value="69"/>
                    <measurement group_id="B5" value="416"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values</title>
        <description>Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values</description>
        <time_frame>28 Weeks</time_frame>
        <population>Japanese Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>BGF MDI 320/14.4/9.6 ug</title>
            <description>Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>BFF MDI 320/9.6 ug</title>
            <description>Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug</description>
          </group>
          <group group_id="O4">
            <title>Symbicort TBH 400/12 ug</title>
            <description>Open Label Symbicort Turbuhaler 400/12 ug BID</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values</title>
          <description>Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values</description>
          <population>Japanese Safety Population</population>
          <units>Count of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="137"/>
                <count group_id="O2" value="137"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT &gt;3 x ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin &gt;2 x ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (mmol/L) &gt;6.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose (mmol/L) &gt;13.9 if Baseline is ≤10.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose (mmol/L) &gt;16.7 if baseline is &gt;10.0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs</title>
        <description>Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs</description>
        <time_frame>28 Weeks</time_frame>
        <population>Japanese Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>BGF MDI 320/14.4/9.6 ug</title>
            <description>Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>BFF MDI 320/9.6 ug</title>
            <description>Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug</description>
          </group>
          <group group_id="O4">
            <title>Symbicort TBH 400/12 ug</title>
            <description>Open Label Symbicort Turbuhaler 400/12 ug BID</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs</title>
          <description>Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs</description>
          <population>Japanese Safety Population</population>
          <units>Particpants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
                <count group_id="O2" value="138"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure &gt;=180, Incr &gt;=20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure, &lt;=90, Decr &gt;=20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure, &gt;=105 Incr, &gt;=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure, &lt;=50, Decr &gt;=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tachycardia Event &gt;=110, Incr &gt;=15%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bradycardia Event &lt;=50, Decr &gt;=15%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values</title>
        <description>Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values</description>
        <time_frame>28 Weeks</time_frame>
        <population>Japanese Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>BGF MDI 320/14.4/9.6 ug</title>
            <description>Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>BFF MDI 320/9.6 ug</title>
            <description>Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug</description>
          </group>
          <group group_id="O4">
            <title>Symbicort TBH 400/12 ug</title>
            <description>Open Label Symbicort Turbuhaler 400/12 ug BID</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values</title>
          <description>Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values</description>
          <population>Japanese Safety Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
                <count group_id="O2" value="138"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt;=500 if &lt;500 msec at BL and change &gt;=15 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=530 if &gt;=500 msec at BL and &gt;=15 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 500 msec and &gt;= 15 msec change from BL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase from baseline is &gt;=60 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Value is &gt;500 msec and increase &gt;=60 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks.</time_frame>
      <desc>The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>BGF MDI 320/14.4/9.6 ug</title>
          <description>Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug</description>
        </group>
        <group group_id="E2">
          <title>GFF MDI 14.4/9.6 ug</title>
          <description>Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug</description>
        </group>
        <group group_id="E3">
          <title>BFF MDI 320/9.6 ug</title>
          <description>Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug</description>
        </group>
        <group group_id="E4">
          <title>Symbicort TBH 400/12 ug BID</title>
          <description>Open Label Symbicort Turbuhaler 400/12 ug BID</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="3" subjects_at_risk="139"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="139"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="138"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="70"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Oesophageal rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="139"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="138"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Oropharyngeal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma gastric</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm of thymus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Urethral cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Lung Adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disorder</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="139"/>
                <counts group_id="E2" events="21" subjects_affected="11" subjects_at_risk="138"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="138"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acute febrile neutrophilic dermatosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="138"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="82" subjects_at_risk="139"/>
                <counts group_id="E2" subjects_affected="75" subjects_at_risk="138"/>
                <counts group_id="E3" subjects_affected="40" subjects_at_risk="70"/>
                <counts group_id="E4" subjects_affected="38" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="139"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="138"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="69" subjects_affected="45" subjects_at_risk="139"/>
                <counts group_id="E2" events="57" subjects_affected="43" subjects_at_risk="138"/>
                <counts group_id="E3" events="33" subjects_affected="22" subjects_at_risk="70"/>
                <counts group_id="E4" events="30" subjects_affected="24" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="20" subjects_affected="14" subjects_at_risk="139"/>
                <counts group_id="E2" events="20" subjects_affected="11" subjects_at_risk="138"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="70"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="139"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="138"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="139"/>
                <counts group_id="E2" events="12" subjects_affected="8" subjects_at_risk="138"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="139"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="138"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="70"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper Respiratory tract inflammation</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="139"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="138"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="138"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="70"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="138"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="69"/>
              </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>Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Paul M. Dorinsky, MD</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>1-877-240-9479</phone>
      <email>information.center@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/NCT03262012
org study id: PT010007
nct id: NCT03262012
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term
      Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very
      Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®
This is a multicenter, randomized, double-blind, parallel group, chronic dosing,
      active-controlled, 28-week, safety extension of Study PT010006 to assess the safety and
      efficacy of BGF MDI, GFF MDI, BFF MDI, and Symbicort TBH as an active control over a 52-week
      period in Japanese subjects with moderate to very severe COPD who remain symptomatic on
      maintenance treatment with either an ICS and one or more bronchodilator(s) or two or more
      maintenance bronchodilators.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Double Blind
measure: Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values
time frame: 28 Weeks
description: Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values
measure: Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
time frame: 28 Weeks
description: Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
measure: Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
time frame: 28 Weeks
description: Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
arm group label: BGF MDI (PT010)
arm group type: Experimental
description: Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
arm group label: GFF MDI (PT003)
arm group type: Experimental
description: Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
arm group label: BFF MDI (PT009)
arm group type: Experimental
description: Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009
arm group label: Symbicort® Turbohaler® Inhalation Powder
arm group type: Active Comparator
description: Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler
intervention type: Drug
intervention name: BGF MDI (PT010)
description: Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
arm group label: BGF MDI (PT010)
other name: BGF
intervention type: Drug
intervention name: GFF MDI (PT003)
description: Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
arm group label: GFF MDI (PT003)
other name: GFF
intervention type: Drug
intervention name: BFF MDI (PT009)
description: Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009
arm group label: BFF MDI (PT009)
other name: BFF
intervention type: Drug
intervention name: Symbicort® Turbohaler® Inhalation Powder
description: Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler
arm group label: Symbicort® Turbohaler® Inhalation Powder
other name: Symbicort
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Paul M. Dorinsky, MD
role: Study Director
affiliation: Pearl Therapeutics, Inc.
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country: Japan
responsible party type: Sponsor
mesh term: Budesonide, Formoterol Fumarate Drug Combination
sharing ipd: Yes
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certain agreements: 
point of contact: 