<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/NCT02231424</url>
  </required_header>
  <id_info>
    <org_study_id>215.1353</org_study_id>
    <nct_id>NCT02231424</nct_id>
  </id_info>
  <brief_title>Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease</brief_title>
  <official_title>Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The aim of this postmarketing surveillance is to obtain further information about the&#xD;
      tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic&#xD;
      obstructive respiratory tract disease under conditions of daily practice&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 1999</start_date>
  <primary_completion_date type="Actual">November 1999</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>Overall severity of the clinical picture rated on a 4-point scale</measure>
    <time_frame>after 3 and 6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in dyspnea and/or asthma attacks rated on a 4-point scale</measure>
    <time_frame>after 3 and 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of dyspnea episodes rated on a 4-point scale</measure>
    <time_frame>after 3 and 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of awakenings due to night-time dyspnea rated on a 4-point scale</measure>
    <time_frame>after 3 and 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of morning coughing with expectoration rated on a 4-point scale</measure>
    <time_frame>after 3 and 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability on a 4-point scale</measure>
    <time_frame>after 3 and 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse drug reactions</measure>
    <time_frame>up to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pathological auscultation findings rated on a 3-point scale</measure>
    <time_frame>after 3 and 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in concomitant medication</measure>
    <time_frame>up to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of efficacy on a 4-point scale</measure>
    <time_frame>after 3 and 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">713</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>chronic obstructive respiratory tract disease patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug: Berodual®</intervention_name>
    <arm_group_label>chronic obstructive respiratory tract disease patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diagnosis of chronic obstructive respiratory tract disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of either sex, including children over 6 years&#xD;
&#xD;
          -  Chronic obstructive respiratory tract disease. Every doctor was asked to include in&#xD;
             this study the first patients coming after each other, who were treated for the first&#xD;
             time with Berodual® metered dose inhaler (MDI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications listed in the Instructions for Use/Summary of Product&#xD;
             Characteristics of Berodual® metered-dose inhaler&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 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 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 1, 2014</last_update_submitted>
  <last_update_submitted_qc>September 1, 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>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Lung Diseases, 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/NCT02231424
org study id: 215.1353
nct id: NCT02231424
lead sponsor: 
The aim of this postmarketing surveillance is to obtain further information about the
      tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic
      obstructive respiratory tract disease under conditions of daily practice
observational model: Cohort
time perspective: Prospective
measure: Overall severity of the clinical picture rated on a 4-point scale
time frame: after 3 and 6 weeks
measure: Changes in dyspnea and/or asthma attacks rated on a 4-point scale
time frame: after 3 and 6 weeks
measure: Number of dyspnea episodes rated on a 4-point scale
time frame: after 3 and 6 weeks
measure: Number of awakenings due to night-time dyspnea rated on a 4-point scale
time frame: after 3 and 6 weeks
measure: Assessment of morning coughing with expectoration rated on a 4-point scale
time frame: after 3 and 6 weeks
measure: Assessment of tolerability on a 4-point scale
time frame: after 3 and 6 weeks
measure: Number of patients with adverse drug reactions
time frame: up to 6 weeks
measure: Changes in pathological auscultation findings rated on a 3-point scale
time frame: after 3 and 6 weeks
measure: Changes in concomitant medication
time frame: up to 6 weeks
measure: Assessment of efficacy on a 4-point scale
time frame: after 3 and 6 weeks
arm group label: chronic obstructive respiratory tract disease patients
intervention type: Drug
intervention name: Drug: Berodual®
arm group label: chronic obstructive respiratory tract disease patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
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: Lung Diseases, Obstructive
mesh term: Fenoterol, ipratropium drug combination