<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/NCT02196194</url>
  </required_header>
  <id_info>
    <org_study_id>205.290</org_study_id>
    <nct_id>NCT02196194</nct_id>
  </id_info>
  <brief_title>A Prescription-Event Monitoring (PEM) Study of Tiotropium</brief_title>
  <official_title>A Prescription-Event Monitoring (PEM) Study of Tiotropium Based on Prescription Data Collected by the Prescription Pricing Authority (PPA) in England for Tiotropium (Spiriva®)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      This prescription-event monitoring study was based upon 'event' monitoring and so capable of&#xD;
      identifying signals of events that might be associated with the use of tiotropium, which none&#xD;
      of the participating general practitioners (GPs) suspected to be an adverse drug reaction.&#xD;
      The methodology of this study readily permits follow up of specific events and the obtaining&#xD;
      of additional data as appropriate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2002</start_date>
  <primary_completion_date type="Actual">August 2003</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incidence density of events</measure>
    <time_frame>up to sixth month of treatment</time_frame>
    <description>incidence density per 1000 patient-months of treatment</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">13891</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>tiotropium</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tiotropium</intervention_name>
    <arm_group_label>tiotropium</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with tiotropium&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who were prescribed tiotropium&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not applicable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</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>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tiotropium Bromide</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02196194
org study id: 205.290
nct id: NCT02196194
lead sponsor: 
This prescription-event monitoring study was based upon 'event' monitoring and so capable of
      identifying signals of events that might be associated with the use of tiotropium, which none
      of the participating general practitioners (GPs) suspected to be an adverse drug reaction.
      The methodology of this study readily permits follow up of specific events and the obtaining
      of additional data as appropriate.
observational model: Cohort
time perspective: Retrospective
measure: incidence density of events
time frame: up to sixth month of treatment
description: incidence density per 1000 patient-months of treatment
arm group label: tiotropium
intervention type: Drug
intervention name: Tiotropium
arm group label: tiotropium
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Tiotropium Bromide