<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/NCT03022097</url>
  </required_header>
  <id_info>
    <org_study_id>D6570C00002</org_study_id>
    <secondary_id>M-AS464-30</secondary_id>
    <nct_id>NCT03022097</nct_id>
  </id_info>
  <brief_title>Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients</brief_title>
  <acronym>AVANT</acronym>
  <official_title>A 24-week Treatment, Randomised, Parallel-group, Double Blinded, Double-Dummy, Multicenter Study to Assess the Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Compared With Individual Components and Placebo and Aclidinium Bromide Compared With Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and&#xD;
      multinational Phase III study to determine the efficacy and safety of Aclidinium&#xD;
      bromide/Formoterol fumarate compared with individual components and placebo and Aclidinium&#xD;
      bromide compared with Placebo when administered to patients with stable Chronic Obstructive&#xD;
      Pulmonary Disease (COPD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2017</start_date>
  <completion_date type="Actual">April 14, 2022</completion_date>
  <primary_completion_date type="Actual">April 14, 2022</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>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in 1-hour morning post-dose dose Forced expiratory volume in 1 second (FEV1)</measure>
    <time_frame>Week 24</time_frame>
    <description>Change from baseline in 1-hour morning post-dose dose FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Aclidinium bromide at Week 24.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in morning pre-dose (trough) FEV1</measure>
    <time_frame>Week 24</time_frame>
    <description>Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Formoterol fumarate at Week 24.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in trough FEV1</measure>
    <time_frame>Week 24</time_frame>
    <description>Change from baseline in trough FEV1 of Aclidinium bromide 400 μg compared to placebo at Week 24.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in peak FEV1</measure>
    <time_frame>Week 24</time_frame>
    <description>Change from baseline in peak FEV1 of Aclidinium bromide 400 μg compared to placebo at week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements Transition Dyspnoea Index (TDI) focal score</measure>
    <time_frame>Week 24</time_frame>
    <description>Improvements TDI focal score of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and Aclidinium bromide 400μg compared to placebo at week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in St Georges Respiratory Questionnaire (SGRQ) total score</measure>
    <time_frame>Week 24</time_frame>
    <description>Change from baseline in SGRQ total score of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and Aclidinium bromide 400μg compared to placebo at week 24</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1067</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Experimental 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aclidinium bromide 400μg/Formoterol fumarate 12 μg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aclidinium bromide 400 μg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Formoterol fumarate 12 μg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aclidinium bromide/formoterol Fixed-Dose Combination</intervention_name>
    <description>Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair</description>
    <arm_group_label>Experimental 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aclidinium bromide</intervention_name>
    <description>Inhaled Aclidinium bromide 400 μg, twice per day via Genuair</description>
    <arm_group_label>Experimental 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Formoterol Fumarate</intervention_name>
    <description>Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler</description>
    <arm_group_label>Comparator</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Adult male or non-pregnant, non-lactating female patients aged ≥40&#xD;
&#xD;
          -  2. Patients with a diagnosis of COPD prior to Visit 1 (screening)&#xD;
&#xD;
          -  3. Patients with moderate to severe stable COPD (Stage II or Stage III) at Visit 1:&#xD;
             post-bronchodilator FEV1 ≥30% and &lt; 80% and post-bronchodilator FEV1/Forced vital&#xD;
             capacity (FVC) &lt; 70%&#xD;
&#xD;
          -  4. Current or former smokers with a smoking history of ≥ 10 pack-years&#xD;
&#xD;
          -  5. Patients able to perform repeatable pulmonary function testing for FEV1 according&#xD;
             to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005&#xD;
             criteria at Visit 1(screening)&#xD;
&#xD;
          -  6. Patients who understand the study procedures and are willing to participate in the&#xD;
             study as indicated by signing the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Involvement in the planning and/or conduct of the study (applies to AstraZeneca&#xD;
             staff and/or site staff) or patients employed by or relatives of the employees of the&#xD;
             site or sponsor.&#xD;
&#xD;
          -  2. Previous enrolment or randomisation in the present study&#xD;
&#xD;
          -  3. History or current diagnosis of asthma&#xD;
&#xD;
          -  4. Any respiratory tract infection (including the upper respiratory tract) or COPD&#xD;
             exacerbation (including the mild COPD exacerbation) within 6 weeks prior to screening&#xD;
             or during the run-in period&#xD;
&#xD;
          -  5. Patients hospitalized for COPD exacerbation (an emergency room visit for longer&#xD;
             than 24 hours will be considered a hospitalization) within 3 months prior to screening&#xD;
             and during the run-in period&#xD;
&#xD;
          -  6. Clinically significant respiratory conditions other than COPD&#xD;
&#xD;
          -  7. Patients who in the Investigator's opinion may need to start a pulmonary&#xD;
             rehabilitation program during the study and/or patients who started/finished it within&#xD;
             3 months prior to screening&#xD;
&#xD;
          -  8. Use of long-term oxygen therapy (≥15 hours/day)&#xD;
&#xD;
          -  9. Patient who does not maintain regular day/night, waking/sleeping cycles including&#xD;
             night shift workers&#xD;
&#xD;
          -  10. Clinically significant cardiovascular conditions&#xD;
&#xD;
          -  11. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or&#xD;
             hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated&#xD;
             hypertension&#xD;
&#xD;
          -  12. Patients with QT corrected interval (QTc) using Fridericia formula (QTcF) (QTc=QT/&#xD;
             Duration in milliseconds between two R peaks of two consecutive QRS complexes (RR1/3)&#xD;
             &gt;470 msec as indicated in the centralised reading report assessed at Screening (Visit&#xD;
             1)&#xD;
&#xD;
          -  13. Patients with clinically significant abnormalities in the clinical laboratory&#xD;
             tests, ECG parameters (other than QTcF) or in the physical examination at Visit 1&#xD;
             (screening)&#xD;
&#xD;
          -  14. Patients with abnormal liver function tests defined as Aspartate aminotransferase&#xD;
             (AST), Alanine aminotransferase (ALT), or total bilirubin ≥ 2.5 times upper limit of&#xD;
             normal ranges at screening&#xD;
&#xD;
          -  15. Patient with known non-controlled history of infection with human immunodeficiency&#xD;
             virus and/or active hepatitis&#xD;
&#xD;
          -  16. Patient with a history of hypersensitivity reaction to inhaled anticholinergic&#xD;
             drugs, sympathomimetic amines, inhaled medication or any component thereof&#xD;
&#xD;
          -  17. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction,&#xD;
             acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy&#xD;
&#xD;
          -  18. History of malignancy of any organ system (including lung cancer), treated or&#xD;
             untreated, within the past 5 years other than basal or squamous cell skin cancer&#xD;
&#xD;
          -  19. Any other serious or uncontrolled physical or mental dysfunction&#xD;
&#xD;
          -  20. Patients with a history (within 2 years prior to Visit 1 (screening) of drug&#xD;
             and/or alcohol abuse that may prevent study compliance based on the Investigator&#xD;
             judgment&#xD;
&#xD;
          -  21. Patients unlikely to be cooperative or cannot comply with the study procedures&#xD;
&#xD;
          -  22. Patients treated with any investigational drug within 30 days (or 6 half-lives,&#xD;
             whichever is longer) prior to screening&#xD;
&#xD;
          -  23. Patients who intended to use any concomitant medication not permitted by this&#xD;
             protocol or who had not undergone the required washout period for a particular&#xD;
             prohibited medication&#xD;
&#xD;
          -  24. Patients unable to give consent, or patients of consenting age but under&#xD;
             guardianship, or vulnerable patients&#xD;
&#xD;
          -  25. Any other conditions that, in the Investigator's opinion, might have indicated the&#xD;
             patient to be unsuitable for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Anhui</city>
        <zip>230061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baotou</city>
        <zip>14010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beijing</city>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beijing</city>
        <zip>100097</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beijing</city>
        <zip>CN-100083</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cangzhou</city>
        <zip>61000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changchun</city>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changsha</city>
        <zip>410005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Changsha</city>
        <zip>430033</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chengdu</city>
        <zip>610072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guangzhou</city>
        <zip>510530</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Haikou</city>
        <zip>570311</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <zip>310005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hangzhou</city>
        <zip>310014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hefei</city>
        <zip>230001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hefei</city>
        <zip>230022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hengyang</city>
        <zip>50012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hohhot</city>
        <zip>010017</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Liangyugang</city>
        <zip>222002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Linhai</city>
        <zip>317000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nanchang</city>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nanjing</city>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Qiqihar</city>
        <zip>161005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200062</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200090</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200240</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <zip>201200</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanxi</city>
        <zip>30001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shengyang</city>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shenzhen</city>
        <zip>518020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shenzhen</city>
        <zip>518053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shijiazhuang</city>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taiyuan</city>
        <zip>030001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tianjin</city>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wenzhou</city>
        <zip>325015</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wuxi</city>
        <zip>214023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Xiamen</city>
        <zip>361004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Xian</city>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Xining</city>
        <zip>810007</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yangzhou</city>
        <zip>225000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yanji</city>
        <zip>133000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yinchuan</city>
        <zip>750004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zhanjiang</city>
        <zip>524001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ahmedabad</city>
        <zip>380060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Alappuzha</city>
        <zip>688524</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ernakulam</city>
        <zip>683577</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Guntur</city>
        <zip>522001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jaipur</city>
        <zip>302006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kozhikode</city>
        <zip>673008</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mysore</city>
        <zip>57002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagpur</city>
        <zip>440010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagpur</city>
        <zip>440012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagpur</city>
        <zip>440019</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pune</city>
        <zip>411019</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pune</city>
        <zip>411057</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pune</city>
        <zip>440012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vijayawada</city>
        <zip>520 008</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Caloocan City</city>
        <zip>1400</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iloilo City</city>
        <zip>5000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manila</city>
        <zip>1000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Quezon City</city>
        <zip>1000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Quezon City</city>
        <zip>1100</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Quezon City</city>
        <zip>1101</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Keelung</city>
        <zip>20448</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taichung</city>
        <zip>40201</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hanoi</city>
        <zip>10000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ho Chi Minh City</city>
        <zip>700000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ho Chi Minh City</city>
        <zip>70000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ho Chi Minh</city>
        <zip>70000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>India</country>
    <country>Philippines</country>
    <country>Taiwan</country>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>May 23, 2022</last_update_submitted>
  <last_update_submitted_qc>May 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</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>Bromides</mesh_term>
    <mesh_term>Formoterol Fumarate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>March 7, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03022097
org study id: D6570C00002
secondary id: M-AS464-30
nct id: NCT03022097
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and
      multinational Phase III study to determine the efficacy and safety of Aclidinium
      bromide/Formoterol fumarate compared with individual components and placebo and Aclidinium
      bromide compared with Placebo when administered to patients with stable Chronic Obstructive
      Pulmonary Disease (COPD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline in 1-hour morning post-dose dose Forced expiratory volume in 1 second (FEV1)
time frame: Week 24
description: Change from baseline in 1-hour morning post-dose dose FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Aclidinium bromide at Week 24.
measure: Change from baseline in morning pre-dose (trough) FEV1
time frame: Week 24
description: Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Formoterol fumarate at Week 24.
measure: Change from baseline in trough FEV1
time frame: Week 24
description: Change from baseline in trough FEV1 of Aclidinium bromide 400 μg compared to placebo at Week 24.
measure: Change from baseline in peak FEV1
time frame: Week 24
description: Change from baseline in peak FEV1 of Aclidinium bromide 400 μg compared to placebo at week 24
measure: Improvements Transition Dyspnoea Index (TDI) focal score
time frame: Week 24
description: Improvements TDI focal score of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and Aclidinium bromide 400μg compared to placebo at week 24
measure: Change from baseline in St Georges Respiratory Questionnaire (SGRQ) total score
time frame: Week 24
description: Change from baseline in SGRQ total score of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and Aclidinium bromide 400μg compared to placebo at week 24
arm group label: Experimental 1
arm group type: Experimental
description: Aclidinium bromide 400μg/Formoterol fumarate 12 μg
arm group label: Experimental 2
arm group type: Experimental
description: Aclidinium bromide 400 μg
arm group label: Comparator
arm group type: Active Comparator
description: Formoterol fumarate 12 μg
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Aclidinium bromide/formoterol Fixed-Dose Combination
description: Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair
arm group label: Experimental 1
intervention type: Drug
intervention name: Aclidinium bromide
description: Inhaled Aclidinium bromide 400 μg, twice per day via Genuair
arm group label: Experimental 2
intervention type: Drug
intervention name: Formoterol Fumarate
description: Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler
arm group label: Comparator
intervention type: Drug
intervention name: Placebo
description: Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 130 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
country: India
country: Philippines
country: Taiwan
country: Vietnam
responsible party type: Sponsor
mesh term: Bromides
mesh term: Formoterol Fumarate
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home
submitted: March 7, 2023