xml: <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/NCT05977699</url>
    </required_header>
    <id_info>
      <org_study_id>BIO 3632</org_study_id>
      <nct_id>NCT05977699</nct_id>
    </id_info>
    <brief_title>Reversibility of Methacholine Induced Bronchoconstriction</brief_title>
    <official_title>Salbutamol Reversal of Methacholine Induced Bronchoconstriction: Vibrating Mesh Nebulizer Versus Pressurized Metered Dose Inhaler</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study will compare salbutamol reversibility of methacholine induced bronchoconstriction&#xD;
        between a pressurized metered dose inhaler with a spacer versus nebulizer administration&#xD;
        using a vibrating mesh nebulizer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Lung function recovery</measure>
      <time_frame>up to 60 minutes post salbutamol administration</time_frame>
      <description>Maximal recovery in FEV1 and FVC (absolute volume and percent)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to lung function recovery</measure>
      <time_frame>0-60 minutes</time_frame>
      <description>Area under the curve from start of salbutamol administration to time at which maximal recovery occurs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate</measure>
      <time_frame>0-60 minutes</time_frame>
      <description>change in pulse after salbutamol administration</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Asthma</condition>
    <arm_group>
      <arm_group_label>salbutamol delivered via pressurized metered dose inhaler</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>200mcg of salbutamol will be delivered using a pressurized metered dose inhaler plus spacer</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>normal saline will be administered with a vibrating mesh nebulizer and 200mcg of placebo will be administered using a pressurized metered dose inhaler plus spacer</description>
    </arm_group>
    <arm_group>
      <arm_group_label>salbutamol delivered with vibrating mesh nebulizer</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>200microliters of salbutamol will be administered using a vibrating mesh nebulizer</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>salbutamol aqueous solution</intervention_name>
      <description>administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a vibrating mesh nebulizer</description>
      <arm_group_label>salbutamol delivered with vibrating mesh nebulizer</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>salbutamol pressurized metered dose inhaler</intervention_name>
      <description>administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a pressurized metered dose inhaler plus spacer</description>
      <arm_group_label>salbutamol delivered via pressurized metered dose inhaler</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>placebo</intervention_name>
      <description>matching placebo delivered via pressurized metered dose inhaler plus spacer or normal saline via vibrating mesh nebulizer</description>
      <arm_group_label>placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age (years) at least 18, male or female&#xD;
  &#xD;
            -  no confounding health issue (i.e. no health conditions, other than asthma, that would&#xD;
               put the participant at risk or affect data integrity)&#xD;
  &#xD;
            -  baseline FEV1 ≥ 65% predicted (per Quanjer GLI 2012)&#xD;
  &#xD;
            -  methacholine PD20 ≤ 800mcg&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  respiratory infection within 4 weeks of Visit 1&#xD;
  &#xD;
            -  exposure to triggers of respiratory symptoms within 4 weeks of Visit 1&#xD;
  &#xD;
            -  currently pregnant or breastfeeding&#xD;
  &#xD;
            -  current smoker (cigarettes, vaping)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Don Cockcroft, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Saskatchewan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Beth Davis, PhD</last_name>
      <phone>306-844-1444</phone>
      <email>Beth.davis@usask.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall</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>July 2023</verification_date>
    <study_first_submitted>June 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
      <investigator_full_name>Don Cockcroft</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Albuterol</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977699
  org study id: BIO 3632
  nct id: NCT05977699
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The study will compare salbutamol reversibility of methacholine induced bronchoconstriction
        between a pressurized metered dose inhaler with a spacer versus nebulizer administration
        using a vibrating mesh nebulizer.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Lung function recovery
  time frame: up to 60 minutes post salbutamol administration
  description: Maximal recovery in FEV1 and FVC (absolute volume and percent)
  measure: Time to lung function recovery
  time frame: 0-60 minutes
  description: Area under the curve from start of salbutamol administration to time at which maximal recovery occurs
  measure: Heart rate
  time frame: 0-60 minutes
  description: change in pulse after salbutamol administration
  arm group label: salbutamol delivered via pressurized metered dose inhaler
  arm group type: Active Comparator
  description: 200mcg of salbutamol will be delivered using a pressurized metered dose inhaler plus spacer
  arm group label: placebo
  arm group type: Placebo Comparator
  description: normal saline will be administered with a vibrating mesh nebulizer and 200mcg of placebo will be administered using a pressurized metered dose inhaler plus spacer
  arm group label: salbutamol delivered with vibrating mesh nebulizer
  arm group type: Experimental
  description: 200microliters of salbutamol will be administered using a vibrating mesh nebulizer
  intervention type: Drug
  intervention name: salbutamol aqueous solution
  description: administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a vibrating mesh nebulizer
  arm group label: salbutamol delivered with vibrating mesh nebulizer
  intervention type: Drug
  intervention name: salbutamol pressurized metered dose inhaler
  description: administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a pressurized metered dose inhaler plus spacer
  arm group label: salbutamol delivered via pressurized metered dose inhaler
  intervention type: Other
  intervention name: placebo
  description: matching placebo delivered via pressurized metered dose inhaler plus spacer or normal saline via vibrating mesh nebulizer
  arm group label: placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Don Cockcroft, MD
  role: Principal Investigator
  affiliation: University of Saskatchewan
  last name: Beth Davis, PhD
  phone: 306-844-1444
  email: Beth.davis@usask.ca
  facility: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of Saskatchewan
  investigator full name: Don Cockcroft
  investigator title: Professor
  mesh term: Albuterol