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/NCT05970263</url>
    </required_header>
    <id_info>
      <org_study_id>D5980C00034</org_study_id>
      <nct_id>NCT05970263</nct_id>
    </id_info>
    <brief_title>IKANOS: Breztri Maintenance Versus Any Non-Triple Inhaled Therapy After Hospitalization for a COPD Exacerbation in the US</brief_title>
    <acronym>IKANOS</acronym>
    <official_title>IKANOS: A Prospective, Open-Label, Minimally Interventional Hybrid Study in the US Comparing Initiation of Breztri Maintenance Versus Any Non-Triple Inhaled Therapy at Discharge After a Hospitalization for a COPD Exacerbation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Iqvia Pty Ltd</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Premier Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>AstraZeneca</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will evaluate whether prompt initiation and maintenance of Breztri (a triple&#xD;
        therapy) following a severe COPD exacerbation hospitalization, is associated with a lower&#xD;
        risk of all-cause readmissions at 90 days post-discharge, compared to receiving any&#xD;
        non-triple inhaled therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        IKANOS is a prospective, open-label, minimally interventional Hybrid Study in the US&#xD;
        Comparing Initiation of Breztri Maintenance versus Any Non-Triple Inhaled Therapy at&#xD;
        Discharge after a Hospitalization for a COPD Exacerbation.&#xD;
  &#xD;
        The interventional arm will be comprised of around 1000 patients for whom Breztri maintenance&#xD;
        is prescribed, and the first dose is received prior to hospital discharge (the &quot;index&#xD;
        discharge&quot;) after a severe COPD exacerbation (the index admission).&#xD;
  &#xD;
        At the end of the recruitment period of the interventional arm, the external comparator arm&#xD;
        will be constructed from real-world data of patients contemporaneous with those in the&#xD;
        interventional arm, from the same or similar integrated delivery network as the&#xD;
        interventional arm and who are similar in key clinical and demographic characteristics.&#xD;
  &#xD;
        Patients will be followed-up through their data and call center contact for up to 12 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 13, 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of patients with an all-cause readmission</measure>
      <time_frame>90 days post-index discharge</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of all-cause readmissions</measure>
      <time_frame>90 days post-index discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first all-cause readmission</measure>
      <time_frame>1 year post-index discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with all-cause readmissions</measure>
      <time_frame>30 days and 1 year post-index discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of all-cause readmissions per time period</measure>
      <time_frame>30 days and 1 year post-index discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>proportion of patients experiencing COPD moderate/severe exacerbations</measure>
      <time_frame>30 days, 90 days and 1 year post-index discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>proportion of patients experiencing COPD severe exacerbations</measure>
      <time_frame>30 days, 90 days, and 1 year post-index discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of COPD moderate/severe exacerbations per time period</measure>
      <time_frame>30 days, 90 days, and 1 year post-index discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of COPD severe exacerbations per time period</measure>
      <time_frame>30 days, 90 days, and 1 year post-index discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time to first COPD moderate/severe exacerbations</measure>
      <time_frame>1 year post-index discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time to first COPD severe exacerbations</measure>
      <time_frame>1 year post-index discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>proportion of patients experiencing all-cause mortality</measure>
      <time_frame>90 days and 1 year post-index discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time to all-cause mortality</measure>
      <time_frame>1 year post-index discharge</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>COPD</condition>
    <arm_group>
      <arm_group_label>Breztri</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1. Interventional Arm: patients receive :&#xD;
  First dose of Breztri during hospitalization and discharge with 7-day Breztri inhaler&#xD;
  Breztri refills to cover 12-month follow-up period, mailed in 90-day supply from a central pharmacy. Emergency resupply is also available if needed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>External Comparator - Non-Triple</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>2. External Comparator Arm: patient who receive any non-triple inhaled therapy following a hospitalization for severe COPD exacerbation. This arm will be constructed of de-Identified patient.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily.</intervention_name>
      <description>2 inhalations twice daily administered by oral inhalation, from a metered dose inhaler, over a 12-month follow-up period.</description>
      <arm_group_label>Breztri</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>External Comparator</intervention_name>
      <description>Received any inhaled therapy, excluding triple inhaled maintenance therapy, during index hospitalization and refilled within 30 days before or after discharge from index hospitalization</description>
      <arm_group_label>External Comparator - Non-Triple</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Patients are included into the study if they meet the following criteria :&#xD;
  &#xD;
            1. Adults aged 40 years and above as of the index hospitalization admission date (for the&#xD;
               intervention arm only).&#xD;
  &#xD;
            2. Primary or secondary diagnosis of COPD as documented in the database on or before&#xD;
               admission.&#xD;
  &#xD;
            3. Hospital admission for a COPD exacerbation (primary or secondary cause) (ie, the index&#xD;
               admission).&#xD;
  &#xD;
            4. Availability of at least 6 months of data in the PHD-LRx-Dx database prior to the&#xD;
               index admission (for the comparator arm only).&#xD;
  &#xD;
            5. Additional inclusion criteria for the interventional arm:&#xD;
  &#xD;
                 1. Willingness to use Breztri as an inhaled maintenance medication as prescribed by&#xD;
                    their physician.&#xD;
  &#xD;
                 2. Willingness and ability to sign informed consent during index admission and&#xD;
                    before discharge.&#xD;
  &#xD;
                 3. Availability of home-based access to telephone calls.&#xD;
  &#xD;
                 4. Availability of home-based access to the internet for PRO measurement and inhaler&#xD;
                    training materials.&#xD;
  &#xD;
                 5. Willingness to be contacted by a qualified medical professional for safety&#xD;
                    monitoring.&#xD;
  &#xD;
                 6. Willingness and ability to participate, on their own or through the assistance of&#xD;
                    their caregivers, in remote, online patient-reported outcome measurement at&#xD;
                    designated intervals&#xD;
  &#xD;
                 7. Physician decision that patient is eligible for treatment with Breztri according&#xD;
                    to the approved USPI.&#xD;
  &#xD;
                 8. Any females of childbearing potential must be using a form of highly effective&#xD;
                    methods of contraception and have a negative urine pregnancy test result&#xD;
  &#xD;
            6. Additional inclusion criterion for the comparator arm:&#xD;
  &#xD;
                 1. Received non-triple inhaled therapy for COPD within 30 days prior to discharge or&#xD;
                    up to 30 days post-discharge, including:&#xD;
  &#xD;
                      -  ICS/LABA.&#xD;
  &#xD;
                      -  LABA/LAMA.&#xD;
  &#xD;
                      -  ICS.&#xD;
  &#xD;
                      -  LABA.&#xD;
  &#xD;
                      -  LAMA.&#xD;
  &#xD;
                      -  SABA/SAMA.&#xD;
  &#xD;
                      -  SABA.&#xD;
  &#xD;
                      -  SAMA.&#xD;
  &#xD;
                      -  Other inhaled COPD therapy not classified as triple therapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients are excluded from the study if they meet any of the following criteria:&#xD;
  &#xD;
            1. Having received triple inhaled maintenance therapy (fixed-dose, or open) for COPD or&#xD;
               other indications 6 months prior to index admission.&#xD;
  &#xD;
            2. Any documented use of respiratory biologics 6 months prior to index admission.&#xD;
  &#xD;
            3. Patients on palliative care, including hospice.&#xD;
  &#xD;
            4. Discharge to institutional care other than a rehabilitation facility (eg, other&#xD;
               hospital, or similar). Patients discharged to rehabilitation facility are eligible to&#xD;
               participate. Note: Because patients are enrolled in the intervention arm prior to&#xD;
               discharge, this criterion should be assessed using the working knowledge of the&#xD;
               treating physician at the time of patient enrollment.&#xD;
  &#xD;
            5. Mortality on or before index discharge.&#xD;
  &#xD;
            6. Conditions including lung surgery (excluding thoracentesis or chest tube insertion or&#xD;
               thoracostomy) in 6 months prior to index admission, history of pulmonary lobectomy,&#xD;
               cystic fibrosis, interstitial lung disease, lung cancer, or alpha-1 antitrypsin&#xD;
               deficiency (A1ATD) inducing severe disease as recorded in the PHD-LRx-Dx database.&#xD;
  &#xD;
            7. For females only - currently pregnant (confirmed with positive pregnancy test) or&#xD;
               breast-feeding or planning to become pregnant in the year following index discharge.&#xD;
  &#xD;
            8. Additional exclusion criteria for the interventional arm:&#xD;
  &#xD;
                 1. Discharged on a triple inhaled maintenance therapy in addition to Breztri.&#xD;
  &#xD;
                 2. Patients who have a history of hypersensitivity to β2-agonists, budesonide or any&#xD;
                    other corticosteroid components, glycopyrronium or other&#xD;
                    muscarinicanticholinergics, or any component of the MDI.&#xD;
  &#xD;
                 3. Patients who are clinically unstable, ie, still admitted within the intensive&#xD;
                    care unit,with ongoing dyspnea, requiring vasopressors or round-the-clock&#xD;
                    positive airway pressure ventilatory support.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Igor Barjaktarevic, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>David Geffen School of Medicine</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Adrian Paul J Rabe, DHPEd, MSc, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Imperial College London</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>AstraZeneca Clinical Study Information Center</last_name>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Tampa</city>
          <state>Florida</state>
          <zip>33607</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Peoria</city>
          <state>Illinois</state>
          <zip>61637</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Salisbury</city>
          <state>Maryland</state>
          <zip>21801</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Mount Clemens</city>
          <state>Michigan</state>
          <zip>48043</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Mullica Hill</city>
          <state>New Jersey</state>
          <zip>08062</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Sioux Falls</city>
          <state>South Dakota</state>
          <zip>57105</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>COPD;</keyword>
    <keyword>readmissions;</keyword>
    <keyword>maintenance therapy;</keyword>
    <keyword>triple therapy;</keyword>
    <keyword>real-world evidence;</keyword>
    <keyword>hospital discharge;</keyword>
    <keyword>mortality;</keyword>
    <keyword>cardiopulmonary events,</keyword>
    <keyword>exacerbations</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Budesonide</mesh_term>
      <mesh_term>Glycopyrrolate</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.&#xD;
  All request will be evaluated as per the AZ disclosure commitment:&#xD;
  https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.</ipd_description>
      <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 deidentified 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</ipd_access_criteria>
      <ipd_url>https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_url>
    </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/NCT05970263
  org study id: D5980C00034
  nct id: NCT05970263
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  This study will evaluate whether prompt initiation and maintenance of Breztri (a triple
        therapy) following a severe COPD exacerbation hospitalization, is associated with a lower
        risk of all-cause readmissions at 90 days post-discharge, compared to receiving any
        non-triple inhaled therapy.
  IKANOS is a prospective, open-label, minimally interventional Hybrid Study in the US
        Comparing Initiation of Breztri Maintenance versus Any Non-Triple Inhaled Therapy at
        Discharge after a Hospitalization for a COPD Exacerbation.
  
        The interventional arm will be comprised of around 1000 patients for whom Breztri maintenance
        is prescribed, and the first dose is received prior to hospital discharge (the "index
        discharge") after a severe COPD exacerbation (the index admission).
  
        At the end of the recruitment period of the interventional arm, the external comparator arm
        will be constructed from real-world data of patients contemporaneous with those in the
        interventional arm, from the same or similar integrated delivery network as the
        interventional arm and who are similar in key clinical and demographic characteristics.
  
        Patients will be followed-up through their data and call center contact for up to 12 months.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of patients with an all-cause readmission
  time frame: 90 days post-index discharge
  measure: Number of all-cause readmissions
  time frame: 90 days post-index discharge
  measure: Time to first all-cause readmission
  time frame: 1 year post-index discharge
  measure: Proportion of patients with all-cause readmissions
  time frame: 30 days and 1 year post-index discharge
  measure: number of all-cause readmissions per time period
  time frame: 30 days and 1 year post-index discharge
  measure: proportion of patients experiencing COPD moderate/severe exacerbations
  time frame: 30 days, 90 days and 1 year post-index discharge
  measure: proportion of patients experiencing COPD severe exacerbations
  time frame: 30 days, 90 days, and 1 year post-index discharge
  measure: number of COPD moderate/severe exacerbations per time period
  time frame: 30 days, 90 days, and 1 year post-index discharge
  measure: number of COPD severe exacerbations per time period
  time frame: 30 days, 90 days, and 1 year post-index discharge
  measure: time to first COPD moderate/severe exacerbations
  time frame: 1 year post-index discharge
  measure: time to first COPD severe exacerbations
  time frame: 1 year post-index discharge
  measure: proportion of patients experiencing all-cause mortality
  time frame: 90 days and 1 year post-index discharge
  measure: time to all-cause mortality
  time frame: 1 year post-index discharge
  arm group label: Breztri
  arm group type: Experimental
  description: 1. Interventional Arm: patients receive :
  First dose of Breztri during hospitalization and discharge with 7-day Breztri inhaler
  Breztri refills to cover 12-month follow-up period, mailed in 90-day supply from a central pharmacy. Emergency resupply is also available if needed.
  arm group label: External Comparator - Non-Triple
  arm group type: Other
  description: 2. External Comparator Arm: patient who receive any non-triple inhaled therapy following a hospitalization for severe COPD exacerbation. This arm will be constructed of de-Identified patient.
  intervention type: Drug
  intervention name: Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily.
  description: 2 inhalations twice daily administered by oral inhalation, from a metered dose inhaler, over a 12-month follow-up period.
  arm group label: Breztri
  intervention type: Other
  intervention name: External Comparator
  description: Received any inhaled therapy, excluding triple inhaled maintenance therapy, during index hospitalization and refilled within 30 days before or after discharge from index hospitalization
  arm group label: External Comparator - Non-Triple
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Igor Barjaktarevic, MD, PhD
  role: Principal Investigator
  affiliation: David Geffen School of Medicine
  last name: Adrian Paul J Rabe, DHPEd, MSc, MD
  role: Principal Investigator
  affiliation: Imperial College London
  last name: AstraZeneca Clinical Study Information Center
  phone: 1-877-240-9479
  email: information.center@astrazeneca.com
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Budesonide
  mesh term: Glycopyrrolate
  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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
  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 deidentified 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
  ipd url: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.