<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/NCT02231320</url>
  </required_header>
  <id_info>
    <org_study_id>215.1367</org_study_id>
    <nct_id>NCT02231320</nct_id>
  </id_info>
  <brief_title>Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Berodual® Respimat® 20/50 Microgram/Dose Solution for Inhalation: Assessment of Handling and Patient Satisfaction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      New perceptions about handling and patient satisfaction of the everyday use of Berodual®&#xD;
      Respimat® in patients with chronic obstructive lung disease (COLD). Moreover, further&#xD;
      knowledge should be attained about the tolerability of Berodual® Respimat®&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2005</start_date>
  <primary_completion_date type="Actual">June 2006</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>Number of patients with adverse events</measure>
    <time_frame>up to 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients who premature discontinued therapy with Berodual® Respimat®</measure>
    <time_frame>up to 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler</measure>
    <time_frame>up to 8 weeks</time_frame>
    <description>by means of patient satisfaction and preference questionnaire (PASAPQ)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">236</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Chronic Obstructive Pulmonary Disease patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Berodual® Respimat® - inhaler</intervention_name>
    <arm_group_label>Chronic Obstructive Pulmonary Disease patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diagnosis of chronic obstructive pulmonary disease recruited at pneumologists&#xD;
        in practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients aged at least 18 years who were suffering from symptoms of a&#xD;
             COLD (naive or pre-treated) could be included in the PMS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who meet one or more of the general or specific contraindications mentioned&#xD;
             in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing&#xD;
             Surveillance (PMS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</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>September 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 4, 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>Lung Diseases</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>Fenoterol, ipratropium drug combination</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/NCT02231320
org study id: 215.1367
nct id: NCT02231320
lead sponsor: 
New perceptions about handling and patient satisfaction of the everyday use of Berodual®
      Respimat® in patients with chronic obstructive lung disease (COLD). Moreover, further
      knowledge should be attained about the tolerability of Berodual® Respimat®
observational model: Cohort
time perspective: Prospective
measure: Number of patients with adverse events
time frame: up to 8 weeks
measure: Number of patients who premature discontinued therapy with Berodual® Respimat®
time frame: up to 8 weeks
measure: Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler
time frame: up to 8 weeks
description: by means of patient satisfaction and preference questionnaire (PASAPQ)
arm group label: Chronic Obstructive Pulmonary Disease patients
intervention type: Drug
intervention name: Berodual® Respimat® - inhaler
arm group label: Chronic Obstructive Pulmonary Disease patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Fenoterol, ipratropium drug combination