<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/NCT01699594</url>
  </required_header>
  <id_info>
    <org_study_id>IIS-A-524</org_study_id>
    <secondary_id>BioReb #10-227</secondary_id>
    <nct_id>NCT01699594</nct_id>
  </id_info>
  <brief_title>Change in Airway Responsiveness After Allergen Exposure</brief_title>
  <official_title>Allergen Induced Increase in Indirect Non-allergic Bronchial Reactivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Saskatchewan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The&#xD;
      investigators will look at whether or not exposure to allergens changes the way the airway&#xD;
      responds to a different stimuli (mannitol) and compare that with the known stimuli&#xD;
      (methacholine).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in airway responsiveness three hours after allergen exposure</measure>
    <time_frame>Change from Baseline at 3 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Allergic Asthma</condition>
  <arm_group>
    <arm_group_label>Mannitol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will assess the allergen induced change in airway responsiveness to mannitol bronchoprovocation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methacholine Chloride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will assess the allergen induced change in airway responsiveness to methacholine bronchoprovocation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mannitol</intervention_name>
    <description>Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)</description>
    <arm_group_label>Mannitol</arm_group_label>
    <other_name>Aridol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methacholine Chloride</intervention_name>
    <description>Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)</description>
    <arm_group_label>Methacholine Chloride</arm_group_label>
    <other_name>Provocholine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mild, allergic asthma&#xD;
&#xD;
          -  FEV1 greater than 70% predicted&#xD;
&#xD;
          -  methacholine PC20 less than or equal to 16mg/ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known sensitivity to mannitol or other excipient&#xD;
&#xD;
          -  diagnosis of any other respiratory or non respiratory disease/disorder that would&#xD;
             preclude the individual from participating&#xD;
&#xD;
          -  recent thoracic, abdominal or eye surgery&#xD;
&#xD;
          -  recent allergen exposure (4 weeks), respiratory infection (6 weeks)&#xD;
&#xD;
          -  current immunotherapy&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  history of anaphylaxis&#xD;
&#xD;
          -  use of asthma therapies other than short acting beta agonist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donald W Cockcroft, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Saskatchewan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Saskatchewan</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>April 8, 2015</last_update_submitted>
  <last_update_submitted_qc>April 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>allergies</keyword>
  <keyword>mannitol</keyword>
  <keyword>methacholine</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>Mannitol</mesh_term>
    <mesh_term>Methacholine Chloride</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/NCT01699594
org study id: IIS-A-524
secondary id: BioReb #10-227
nct id: NCT01699594
lead sponsor: 
has dmc: No
Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The
      investigators will look at whether or not exposure to allergens changes the way the airway
      responds to a different stimuli (mannitol) and compare that with the known stimuli
      (methacholine).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change from baseline in airway responsiveness three hours after allergen exposure
time frame: Change from Baseline at 3 hours
arm group label: Mannitol
arm group type: Experimental
description: This arm will assess the allergen induced change in airway responsiveness to mannitol bronchoprovocation.
arm group label: Methacholine Chloride
arm group type: Active Comparator
description: This arm will assess the allergen induced change in airway responsiveness to methacholine bronchoprovocation.
intervention type: Drug
intervention name: Mannitol
description: Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)
arm group label: Mannitol
other name: Aridol
intervention type: Drug
intervention name: Methacholine Chloride
description: Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)
arm group label: Methacholine Chloride
other name: Provocholine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Donald W Cockcroft, MD
role: Principal Investigator
affiliation: University of Saskatchewan
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Asthma
mesh term: Mannitol
mesh term: Methacholine Chloride