<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/NCT02235428</url>
  </required_header>
  <id_info>
    <org_study_id>244.2413</org_study_id>
    <nct_id>NCT02235428</nct_id>
  </id_info>
  <brief_title>Study to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, in Acute Asthmatic Attacks in Young Children</brief_title>
  <official_title>Double-blind, Controlled Trial to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, for 120 Minutes, in Acute Asthmatic Attacks in Young Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To determine whether addition of ipratropium bromide to salbutamol nebulisations produces&#xD;
      significantly greater bronchodilation in young children presenting to an emergency department&#xD;
      with an acute attack of asthma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>September 1998</start_date>
  <primary_completion_date type="Actual">September 1998</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes from baseline in pulmonary resistance (Rint) between T0 and T120</measure>
    <time_frame>Baseline, 120 minutes after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of accessory muscle recruitment on a 4-point scale</measure>
    <time_frame>Up to 120 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of wheezing on a 4-point scale</measure>
    <time_frame>Up to 120 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of dyspnoea on a 4-point scale</measure>
    <time_frame>Up to 120 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in respiratory rate</measure>
    <time_frame>Up to 120 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Oxygen Saturation (ambient air)</measure>
    <time_frame>Up to 120 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in measurement of pulmonary resistance</measure>
    <time_frame>Up to 120 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients dropped out because of lack of efficacy</measure>
    <time_frame>Up to 120 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 17 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients dropped out because of adverse events</measure>
    <time_frame>Up to 17 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in blood pressure</measure>
    <time_frame>Up to 120 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in heart rate</measure>
    <time_frame>Up to 120 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Admission rate</measure>
    <time_frame>120 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Patient Status by investigator on a 3-question list</measure>
    <time_frame>72 hours after drug admimistration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Ipratropium bromide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Salbutamol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ipratropium bromide</intervention_name>
    <arm_group_label>Ipratropium bromide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Salbutamol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salbutamol</intervention_name>
    <arm_group_label>Ipratropium bromide</arm_group_label>
    <arm_group_label>Salbutamol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Boys or girls between 3 and 6 years old&#xD;
&#xD;
          -  Presenting to emergency departments with an acute asthmatic attack&#xD;
&#xD;
          -  Requiring nebulised bronchodilator therapy&#xD;
&#xD;
          -  Rint increased by 200 % compared to theoretical Rint&#xD;
&#xD;
          -  Signed, informed consent obtained from the child's parents/legal guardian in&#xD;
             accordance with current national legislation and good clinical practice (GCP) defined&#xD;
             by the International Conference on Harmonization (ICH)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ipratropium bromide received within four hours before admission&#xD;
&#xD;
          -  First acute asthmatic attack&#xD;
&#xD;
          -  Hospital admission to intensive care with asthma within six months before inclusion&#xD;
&#xD;
          -  Hospital admission for asthma during the month prior to inclusion&#xD;
&#xD;
          -  Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped&#xD;
             corticosteroid therapy&#xD;
&#xD;
          -  Concomitant cardiac disease&#xD;
&#xD;
          -  Life threatening disease requiring immediate management; including: silent chest on&#xD;
             auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma&#xD;
&#xD;
          -  Hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients&#xD;
&#xD;
          -  Renal or hepatic insufficiency&#xD;
&#xD;
          -  Poorly controlled diabetes&#xD;
&#xD;
          -  Patients suffering from a disease considered to be severe by the investigator and&#xD;
             which, in the opinion of the investigator, could interfere or invalidate the&#xD;
             measurements performed in the trial&#xD;
&#xD;
          -  Past history of lung surgery&#xD;
&#xD;
          -  Major respiratory disease: pulmonary fibrosis, bronchiectasis, sarcoidosis,&#xD;
             tuberculosis, respiratory disease due to AIDS, cystic fibrosis&#xD;
&#xD;
          -  Patients unable to follow with protocol or correctly undergo the evaluations&#xD;
&#xD;
          -  Patients who are taking part in another clinical trial during this trial or who have&#xD;
             done so within the month before the trial&#xD;
&#xD;
          -  Previous participation in this trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>6 Years</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 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 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>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bromides</mesh_term>
    <mesh_term>Albuterol</mesh_term>
    <mesh_term>Ipratropium</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/NCT02235428
org study id: 244.2413
nct id: NCT02235428
lead sponsor: 
To determine whether addition of ipratropium bromide to salbutamol nebulisations produces
      significantly greater bronchodilation in young children presenting to an emergency department
      with an acute attack of asthma
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Changes from baseline in pulmonary resistance (Rint) between T0 and T120
time frame: Baseline, 120 minutes after drug administration
measure: Assessment of accessory muscle recruitment on a 4-point scale
time frame: Up to 120 minutes after drug administration
measure: Assessment of wheezing on a 4-point scale
time frame: Up to 120 minutes after drug administration
measure: Assessment of dyspnoea on a 4-point scale
time frame: Up to 120 minutes after drug administration
measure: Changes in respiratory rate
time frame: Up to 120 minutes after drug administration
measure: Changes in Oxygen Saturation (ambient air)
time frame: Up to 120 minutes after drug administration
measure: Changes in measurement of pulmonary resistance
time frame: Up to 120 minutes after drug administration
measure: Number of patients dropped out because of lack of efficacy
time frame: Up to 120 minutes after drug administration
measure: Number of patients with adverse events
time frame: Up to 17 days after last drug administration
measure: Number of patients dropped out because of adverse events
time frame: Up to 17 days after last drug administration
measure: Number of patients with clinical significant findings in blood pressure
time frame: Up to 120 minutes after drug administration
measure: Number of patients with clinical significant findings in heart rate
time frame: Up to 120 minutes after drug administration
measure: Hospital Admission rate
time frame: 120 minutes after drug administration
measure: Assessment of Patient Status by investigator on a 3-question list
time frame: 72 hours after drug admimistration
arm group label: Ipratropium bromide
arm group type: Experimental
arm group label: Salbutamol
arm group type: Active Comparator
intervention type: Drug
intervention name: Ipratropium bromide
arm group label: Ipratropium bromide
intervention type: Drug
intervention name: Placebo
arm group label: Salbutamol
intervention type: Drug
intervention name: Salbutamol
arm group label: Ipratropium bromide
arm group label: Salbutamol
criteria: 
gender: All
minimum age: 3 Years
maximum age: 6 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Asthma
mesh term: Bromides
mesh term: Albuterol
mesh term: Ipratropium