<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/NCT03276754</url>
  </required_header>
  <id_info>
    <org_study_id>B1851177</org_study_id>
    <secondary_id>IMPACE</secondary_id>
    <nct_id>NCT03276754</nct_id>
  </id_info>
  <brief_title>Immunization To Prevent Acute COPD Exacerbations</brief_title>
  <official_title>IMMUNIZATION TO PREVENT ACUTE COPD EXACERBATIONS (IMPACE STUDY)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective multicenter observational study, to evaluate the impact of routine clinical&#xD;
      practice vaccination with PCV13 on the reduction of the risk of moderate/severe COPD&#xD;
      exacerbations&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with chronic obstructive pulmonary disease (COPD) have been demonstrated to have an&#xD;
      increased risk of pneumococcal disease. Pneumonia is frequent among patients hospitalized for&#xD;
      COPD exacerbations and is associated with increased health care utilization and higher&#xD;
      mortality. Up to 50%-70% of exacerbations can be attributed to respiratory infections by&#xD;
      viruses or bacteria, even more in the most severe patients. They are often associated with&#xD;
      the colonization of airways by multiple bacteria or viruses of low virulence that in normal&#xD;
      conditions are parts of the normal flora of the upper airway. Current recommendations for&#xD;
      immunization of patients with COPD include vaccination against influenza and Streptococcus&#xD;
      pneumoniae. The aim of this study is to evaluate the potential benefits of immunization of&#xD;
      COPD patients with PCV13 and/or against influenza in terms of clinical benefits and quality&#xD;
      of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated prematurely due to the inability to recruit the planned number of&#xD;
    subjects and the interim analysis indicated that the number of included patients did not allow&#xD;
    draw any valid conclusion about the main objective of the study&#xD;
  </why_stopped>
  <start_date type="Actual">November 30, 2017</start_date>
  <completion_date type="Actual">June 16, 2022</completion_date>
  <primary_completion_date type="Actual">June 16, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Incidence of moderate or severe COPD exacerbations</measure>
    <time_frame>2 years</time_frame>
    <description>Total number of COPD exacerbations reported by participant / follow up time.&#xD;
Moderate COPD exacerbation: those that require antibiotics and/or systemic corticosteroids without hospitalization.&#xD;
Severe COPD exacerbation: those that lead to hospitalization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COPD severity</measure>
    <time_frame>2 years</time_frame>
    <description>COPD severity classification (GOLD):&#xD;
GRADE 1: Mild/unknown [FEV1≥ 80%, FEV1/FVC &lt; 0,7 or no spirometry data] GRADE 2: Moderate [50% ≤ FEV1&lt; 80%,FEV1/FVC &lt; 0,7] GRADE 3: Severe [30% ≤ FEV1 &lt; 50%, FEV1/FVC &lt; 0,7] GRADE 4: Very severe [FEV1&lt; 30% o FEV1&lt; 50% plus respiratory failure,FEV1/FVC &lt; 0,7])</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Saint George Respiratory Questionnaire Score</measure>
    <time_frame>2 years</time_frame>
    <description>The SGRQ is a specific questionnaire developed to measure health status (quality of life) in patients with chronic airflow limitation.&#xD;
Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CAT (COPD Assessment Tool) questionnaire score</measure>
    <time_frame>2 years</time_frame>
    <description>COPD Assessment Tool is a simple questionnaire that may be used to determine the severity of symptoms. Scores on CAT range from 0-40 with the higher the score, the more severe the disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FEV1 from baseline</measure>
    <time_frame>2 years</time_frame>
    <description>FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed as routine clinical practice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants vaccinated with PCV13</measure>
    <time_frame>2 years</time_frame>
    <description>Percentage of participants vaccinated with PCV13</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of COPD exacerbations/patient/year</measure>
    <time_frame>2 years</time_frame>
    <description>Total number of exacerbations reported by participant / follow up time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean cost per participant</measure>
    <time_frame>2 years</time_frame>
    <description>Overall cost of hospitalization and/or treatment of exacerbation episode based on days of hospitalization /ICU and treatment received.</description>
  </secondary_outcome>
  <enrollment type="Actual">517</enrollment>
  <condition>Pneumococcal Infections</condition>
  <condition>COPD</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects ≥18 years diagnosed with COPD, followed up at the Pulmonology Department of the&#xD;
        partipant centres&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Patient ≥18 years diagnosed with COPD (any stage, the subgroups for the analysis would&#xD;
             be based on COPD severity grade)&#xD;
&#xD;
          2. Ability to understand and complete the required QoL questionnaires&#xD;
&#xD;
          3. At least 2 years of clinical history available that includes records of previous&#xD;
             moderate/severe exacerbations, influenza and pneumococcal vaccination history&#xD;
             comorbidities and previous treatments.&#xD;
&#xD;
          4. Spirometry data (maximum 6 months old, or if not available at enrollment, to be&#xD;
             performed as per normal clinical practice at visit 1 +/- one month)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Impossibility to perform prospective follow up&#xD;
&#xD;
          2. Present any immunocompromising condition&#xD;
&#xD;
          3. Present any other respiratory diseases as co-morbidity (subjects with overlap&#xD;
             syndromes COPD-asthma will be excluded. Mixed phenotype defined as: symptoms of&#xD;
             increased variability of airflow and incompletely reversible airflow obstruction)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Mutua Terrassa</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona</state>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Son Espases</name>
      <address>
        <city>Palma</city>
        <state>Islas Baleares</state>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital el Bierzo</name>
      <address>
        <city>Ponferrada</city>
        <state>León</state>
        <zip>24404</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Alcorcon</name>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>8041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Burgos</name>
      <address>
        <city>Burgos</city>
        <zip>09006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Asistencial de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=B1851177</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pneumococcal infections</keyword>
  <keyword>COPD exacerbations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumococcal Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <!-- 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/NCT03276754
org study id: B1851177
secondary id: IMPACE
nct id: NCT03276754
lead sponsor: 
has dmc: No
Prospective multicenter observational study, to evaluate the impact of routine clinical
      practice vaccination with PCV13 on the reduction of the risk of moderate/severe COPD
      exacerbations
Patients with chronic obstructive pulmonary disease (COPD) have been demonstrated to have an
      increased risk of pneumococcal disease. Pneumonia is frequent among patients hospitalized for
      COPD exacerbations and is associated with increased health care utilization and higher
      mortality. Up to 50%-70% of exacerbations can be attributed to respiratory infections by
      viruses or bacteria, even more in the most severe patients. They are often associated with
      the colonization of airways by multiple bacteria or viruses of low virulence that in normal
      conditions are parts of the normal flora of the upper airway. Current recommendations for
      immunization of patients with COPD include vaccination against influenza and Streptococcus
      pneumoniae. The aim of this study is to evaluate the potential benefits of immunization of
      COPD patients with PCV13 and/or against influenza in terms of clinical benefits and quality
      of life.
observational model: Cohort
time perspective: Prospective
measure: Change in Incidence of moderate or severe COPD exacerbations
time frame: 2 years
description: Total number of COPD exacerbations reported by participant / follow up time.
Moderate COPD exacerbation: those that require antibiotics and/or systemic corticosteroids without hospitalization.
Severe COPD exacerbation: those that lead to hospitalization
measure: COPD severity
time frame: 2 years
description: COPD severity classification (GOLD):
GRADE 1: Mild/unknown [FEV1≥ 80%, FEV1/FVC < 0,7 or no spirometry data] GRADE 2: Moderate [50% ≤ FEV1< 80%,FEV1/FVC < 0,7] GRADE 3: Severe [30% ≤ FEV1 < 50%, FEV1/FVC < 0,7] GRADE 4: Very severe [FEV1< 30% o FEV1< 50% plus respiratory failure,FEV1/FVC < 0,7])
measure: Change from baseline in Saint George Respiratory Questionnaire Score
time frame: 2 years
description: The SGRQ is a specific questionnaire developed to measure health status (quality of life) in patients with chronic airflow limitation.
Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status).
measure: Change in CAT (COPD Assessment Tool) questionnaire score
time frame: 2 years
description: COPD Assessment Tool is a simple questionnaire that may be used to determine the severity of symptoms. Scores on CAT range from 0-40 with the higher the score, the more severe the disease.
measure: Change in FEV1 from baseline
time frame: 2 years
description: FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed as routine clinical practice
measure: Percentage of participants vaccinated with PCV13
time frame: 2 years
description: Percentage of participants vaccinated with PCV13
measure: Change in number of COPD exacerbations/patient/year
time frame: 2 years
description: Total number of exacerbations reported by participant / follow up time
measure: Mean cost per participant
time frame: 2 years
description: Overall cost of hospitalization and/or treatment of exacerbation episode based on days of hospitalization /ICU and treatment received.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
url: https://pmiform.com/clinical-trial-info-request?StudyID=B1851177
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Pneumococcal Infections
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.