xml: <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/NCT06035393</url>
    </required_header>
    <id_info>
      <org_study_id>HRG2005-201</org_study_id>
      <nct_id>NCT06035393</nct_id>
    </id_info>
    <brief_title>A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease</brief_title>
    <official_title>A Phase II, Randomized, Double Blind, Double Dummy, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jiangsu HengRui Medicine Co., Ltd.</source>
    <oversight_info>
      <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 randomized, double blind, double dummy, active-controlled, parallel-group study to&#xD;
        assess the efficacy and Safety of HRG2005 inhalation in patients with moderate to severe&#xD;
        chronic obstructive pulmonary disease. Approximately 200 patients with moderate to severe&#xD;
        COPD will be randomized into the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 27, 2023</start_date>
    <completion_date type="Anticipated">August 28, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 28, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This is a randomized, double blind, double dummy, active-controlled, parallel-group study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in morning pre-dose trough FEV1 at week 12</measure>
      <time_frame>Up to week 12</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in morning pre-dose trough FEV1 at each time point</measure>
      <time_frame>up to week 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point</measure>
      <time_frame>up to week 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1</measure>
      <time_frame>up to week 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak change from baseline in FEV1 at week 12</measure>
      <time_frame>Up to week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FEV1 area under the curve from 0 to 12 hours (AUC0-12), 0 to 24 (AUC0-24) hours at Week 12</measure>
      <time_frame>Up to week 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of moderate or severe COPD exacerbations over 48 Weeks</measure>
      <time_frame>up to week 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of severe COPD exacerbations over 48 Weeks</measure>
      <time_frame>up to week 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in CAT (COPD Assessment test) total score at each time point</measure>
      <time_frame>up to week 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Days with No Rescue use and change from baseline in average daily rescue use at each time point</measure>
      <time_frame>up to week 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence and severity of adverse events</measure>
      <time_frame>Up to week 50</time_frame>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Chronic Obstructive Pulmonary Disease</condition>
    <arm_group>
      <arm_group_label>Treatment group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug1 dose 1+Drug 3</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug1 dose 2+Drug 2+Drug 3</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug1 dose 3+Drug 2+Drug 3</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group D</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Drug 2+Drug 4</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>HRG2005 inhalation</intervention_name>
      <description>Drug 1: dose 1; dose 2; dose 3</description>
      <arm_group_label>Treatment group A</arm_group_label>
      <arm_group_label>Treatment group B</arm_group_label>
      <arm_group_label>Treatment group C</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo to match HRG2005 inhalation</intervention_name>
      <description>Drug 2</description>
      <arm_group_label>Treatment group B</arm_group_label>
      <arm_group_label>Treatment group C</arm_group_label>
      <arm_group_label>Treatment group D</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation</intervention_name>
      <description>Drug 3</description>
      <arm_group_label>Treatment group A</arm_group_label>
      <arm_group_label>Treatment group B</arm_group_label>
      <arm_group_label>Treatment group C</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation</intervention_name>
      <description>Drug 4</description>
      <arm_group_label>Treatment group D</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Able and willing to provide written informed consent and to comply with the study&#xD;
               protocol;&#xD;
  &#xD;
            2. Subjects 40 years of age or older (inclusive), Male or female subjects;&#xD;
  &#xD;
            3. Subjects with an established clinical history of COPD;&#xD;
  &#xD;
            4. A post-bronchodilator FEV1/FVC ratio must be &lt;0.7 at Screening and FEV1 must be &lt;80%&#xD;
               and ≥30% predicted normal at pre-randomization;&#xD;
  &#xD;
            5. Tobacco Use: Current or former smokers with a history of at least 10 pack-years of&#xD;
               cigarette smoking.;&#xD;
  &#xD;
            6. A score of ≥10 on the COPD Assessment Test (CAT) at pre-randomization.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects who required systemic corticosteroids or antibiotics or hospitalized due to&#xD;
               poorly controlled COPD or who had lower respiratory tract infections that required&#xD;
               antibiotics within 4 weeks prior to Screening to pre-randomization;&#xD;
  &#xD;
            2. Subjects who had respiratory tract infections that required antibiotics within 2 weeks&#xD;
               prior to Screening;&#xD;
  &#xD;
            3. Subjects with other respiratory or respiratory related diseases, including but not&#xD;
               limited to asthma, active tuberculosis, lung cancer, interstitial pulmonary disease,&#xD;
               α1-antitrypsin deficiency, pulmonary heart disease, clinically significant pulmonary&#xD;
               hypertension, clinically significant bronchiectasis, or other active pulmonary&#xD;
               disease;&#xD;
  &#xD;
            4. Subjects with lung volume reduction surgery within the 12 months prior to Screening;&#xD;
  &#xD;
            5. Subjects who have Other known serious medical conditions；&#xD;
  &#xD;
            6. Subjects receiving oxygen therapy required for greater than 15 hours a day;&#xD;
  &#xD;
            7. Clinically significant electrocardiogram abnormality；&#xD;
  &#xD;
            8. Subjects with significant laboratory abnormality at screening；&#xD;
  &#xD;
            9. Suspected allergy to any ingredient in the study drug;&#xD;
  &#xD;
           10. Participation in clinical trials of any drug or medical device (except for screening&#xD;
               failures) within 4 weeks before screening, or within 5 half-lives of the drug at&#xD;
               screening (whichever is longer);&#xD;
  &#xD;
           11. Pregnant or lactating females;&#xD;
  &#xD;
           12. History of drug abuse, drinking within one year before screening&#xD;
  &#xD;
           13. Other conditions judged by the investigator to be not suitable to participate in the&#xD;
               trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xiaopeng Wang</last_name>
      <phone>0518-81220121</phone>
      <email>xiaopeng.wang@hengrui.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yin Tong</last_name>
      <phone>0518-81220121</phone>
      <email>yin.tong@hengrui.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glycopyrrolate</mesh_term>
      <mesh_term>Bromides</mesh_term>
      <mesh_term>Maleic acid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035393
  org study id: HRG2005-201
  nct id: NCT06035393
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized, double blind, double dummy, active-controlled, parallel-group study to
        assess the efficacy and Safety of HRG2005 inhalation in patients with moderate to severe
        chronic obstructive pulmonary disease. Approximately 200 patients with moderate to severe
        COPD will be randomized into the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a randomized, double blind, double dummy, active-controlled, parallel-group study.
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Change from baseline in morning pre-dose trough FEV1 at week 12
  time frame: Up to week 12
  measure: Change from baseline in morning pre-dose trough FEV1 at each time point
  time frame: up to week 48
  measure: Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point
  time frame: up to week 48
  measure: Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1
  time frame: up to week 48
  measure: Peak change from baseline in FEV1 at week 12
  time frame: Up to week 12
  measure: FEV1 area under the curve from 0 to 12 hours (AUC0-12), 0 to 24 (AUC0-24) hours at Week 12
  time frame: Up to week 12
  measure: Rate of moderate or severe COPD exacerbations over 48 Weeks
  time frame: up to week 48
  measure: Rate of severe COPD exacerbations over 48 Weeks
  time frame: up to week 48
  measure: Change from baseline in CAT (COPD Assessment test) total score at each time point
  time frame: up to week 48
  measure: Percentage of Days with No Rescue use and change from baseline in average daily rescue use at each time point
  time frame: up to week 48
  measure: Incidence and severity of adverse events
  time frame: Up to week 50
  arm group label: Treatment group A
  arm group type: Experimental
  description: Drug1 dose 1+Drug 3
  arm group label: Treatment group B
  arm group type: Experimental
  description: Drug1 dose 2+Drug 2+Drug 3
  arm group label: Treatment group C
  arm group type: Experimental
  description: Drug1 dose 3+Drug 2+Drug 3
  arm group label: Treatment group D
  arm group type: Other
  description: Drug 2+Drug 4
  intervention type: Drug
  intervention name: HRG2005 inhalation
  description: Drug 1: dose 1; dose 2; dose 3
  arm group label: Treatment group A
  arm group label: Treatment group B
  arm group label: Treatment group C
  intervention type: Drug
  intervention name: Placebo to match HRG2005 inhalation
  description: Drug 2
  arm group label: Treatment group B
  arm group label: Treatment group C
  arm group label: Treatment group D
  intervention type: Drug
  intervention name: Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
  description: Drug 3
  arm group label: Treatment group A
  arm group label: Treatment group B
  arm group label: Treatment group C
  intervention type: Drug
  intervention name: Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
  description: Drug 4
  arm group label: Treatment group D
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xiaopeng Wang
  phone: 0518-81220121
  email: xiaopeng.wang@hengrui.com
  last name: Yin Tong
  phone: 0518-81220121
  email: yin.tong@hengrui.com
  responsible party type: Sponsor
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  mesh term: Glycopyrrolate
  mesh term: Bromides
  mesh term: Maleic acid
  sharing ipd: Undecided