<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/NCT01711086</url>
  </required_header>
  <id_info>
    <org_study_id>0401-11-RMC</org_study_id>
    <nct_id>NCT01711086</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol</brief_title>
  <official_title>Double Blind Placebo Controlled Trial Checking the Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy Steuer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Schneider Children's Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Inspiromedical Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Double-blind study, randomized, controlled, and crossover. Study recruited 30 volunteers with&#xD;
      stable asthma aged 8-18 years. Participants will perform lung function as part of the routine&#xD;
      follow-up then will receive a Foradil 12mcg either with an Aerolizer (a standard dry powder&#xD;
      inhaler) or with the Inspiromatic (an active, breath synchronized innovative inhaler). 3-60&#xD;
      days later participants will receive the same drug through the other inhaler.&#xD;
&#xD;
      Pre and post treatment (15 min, 30 min, 60 min) Lung function results, drug levels in the&#xD;
      blood, vital signs and side effects will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">November 2012</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FEV1</measure>
    <time_frame>We will measure FEV1 post treatment (15 min, 30 min, 60 min)</time_frame>
    <description>Change in FEV1 from base line</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vital signs</measure>
    <time_frame>Pre treatment and than 15 minutes post treatment</time_frame>
    <description>Change in heart rate, blood pressure</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Systemic absorption</measure>
    <time_frame>0 and 15 minutes post inhaltion</time_frame>
    <description>K concentration, Glucose levels and drug level</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Inspiromatic followed by Aerolizer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>volunteers will perform lung function pre and post Formoterol (a bronchodilator) inhalation. They will use either the Inspiromatic dry powder inhalers the delivery device. 3-60 days later participants will receive the same drug through the Aerolizer dry powder inhaler.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aerolizer followed by Inspiromatic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>volunteers will perform lung function pre and post Formoterol (a bronchodilator) inhalation. They will use either the Aerolizer dry powder inhalers the delivery device. 3-60 days later participants will receive the same drug through the Inspiromatic dry powder inhaler.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aerolizer Followed by Inspiromatic</intervention_name>
    <description>Participants will receive Formoterol (Foradil) 12mcg via the Foradil Aerolizer inhaler while performing lung function as part of the and not differ from other routine follow-up</description>
    <arm_group_label>Aerolizer followed by Inspiromatic</arm_group_label>
    <other_name>Foradil Inhaler</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Inspiromatic followed by Aerolizer</intervention_name>
    <description>Participants will receive Formoterol (Foradil) 12mcg via the Inspiromatic dry powder inhaler while performing lung function instead of getting it via the Foradil Aerolizer</description>
    <arm_group_label>Inspiromatic followed by Aerolizer</arm_group_label>
    <other_name>Inspiromatic dry powder experimental inhaler</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children 8-18 years with Asthma&#xD;
&#xD;
          -  50&lt;FEV1&lt;80&#xD;
&#xD;
          -  Can perform Spirometry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor cooperation&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Milk Allergy&#xD;
&#xD;
          -  Other lung disease&#xD;
&#xD;
          -  Prior familiarity with Aerolizer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guy Steuer, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schneider Children Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guy Steuer, M.D.</last_name>
    <phone>+972524249925</phone>
    <email>kids.lung@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hanna Blau, M.D.</last_name>
    <phone>+97239253654</phone>
    <email>hanhblau@post.tau.ac.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Schneider Children Hospital</name>
      <address>
        <city>Petach - Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Guy Steuer, M.D.</last_name>
      <phone>+972524249925</phone>
      <email>kids.lung@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Guy Steuer, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>October 17, 2012</last_update_submitted>
  <last_update_submitted_qc>October 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
    <investigator_full_name>Guy Steuer</investigator_full_name>
    <investigator_title>Guy Steuer, M.D.</investigator_title>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>dry powder inhaler</keyword>
  <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>Formoterol Fumarate</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/NCT01711086
org study id: 0401-11-RMC
nct id: NCT01711086
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Double-blind study, randomized, controlled, and crossover. Study recruited 30 volunteers with
      stable asthma aged 8-18 years. Participants will perform lung function as part of the routine
      follow-up then will receive a Foradil 12mcg either with an Aerolizer (a standard dry powder
      inhaler) or with the Inspiromatic (an active, breath synchronized innovative inhaler). 3-60
      days later participants will receive the same drug through the other inhaler.

      Pre and post treatment (15 min, 30 min, 60 min) Lung function results, drug levels in the
      blood, vital signs and side effects will be recorded.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: FEV1
time frame: We will measure FEV1 post treatment (15 min, 30 min, 60 min)
description: Change in FEV1 from base line
measure: Vital signs
time frame: Pre treatment and than 15 minutes post treatment
description: Change in heart rate, blood pressure
measure: Systemic absorption
time frame: 0 and 15 minutes post inhaltion
description: K concentration, Glucose levels and drug level
arm group label: Inspiromatic followed by Aerolizer
arm group type: Active Comparator
description: volunteers will perform lung function pre and post Formoterol (a bronchodilator) inhalation. They will use either the Inspiromatic dry powder inhalers the delivery device. 3-60 days later participants will receive the same drug through the Aerolizer dry powder inhaler.
arm group label: Aerolizer followed by Inspiromatic
arm group type: Active Comparator
description: volunteers will perform lung function pre and post Formoterol (a bronchodilator) inhalation. They will use either the Aerolizer dry powder inhalers the delivery device. 3-60 days later participants will receive the same drug through the Inspiromatic dry powder inhaler.
intervention type: Device
intervention name: Aerolizer Followed by Inspiromatic
description: Participants will receive Formoterol (Foradil) 12mcg via the Foradil Aerolizer inhaler while performing lung function as part of the and not differ from other routine follow-up
arm group label: Aerolizer followed by Inspiromatic
other name: Foradil Inhaler
intervention type: Device
intervention name: Inspiromatic followed by Aerolizer
description: Participants will receive Formoterol (Foradil) 12mcg via the Inspiromatic dry powder inhaler while performing lung function instead of getting it via the Foradil Aerolizer
arm group label: Inspiromatic followed by Aerolizer
other name: Inspiromatic dry powder experimental inhaler
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: No
last name: Guy Steuer, M.D.
role: Principal Investigator
affiliation: Schneider Children Hospital
last name: Guy Steuer, M.D.
phone: +972524249925
email: kids.lung@gmail.com
last name: Hanna Blau, M.D.
phone: +97239253654
email: hanhblau@post.tau.ac.il
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Sponsor-Investigator
investigator affiliation: Rabin Medical Center
investigator full name: Guy Steuer
investigator title: Guy Steuer, M.D.
mesh term: Asthma
mesh term: Formoterol Fumarate