<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/NCT03238560</url>
  </required_header>
  <id_info>
    <org_study_id>2016Montelukast001</org_study_id>
    <nct_id>NCT03238560</nct_id>
  </id_info>
  <brief_title>The Population Pharmacokinetics of Montelukast in Infants and Children</brief_title>
  <official_title>Population Pharmacokinetics of Montelukast in Infants and Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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 investigators' aim was to evaluate the population pharmacokinetics of montelukast in&#xD;
      infants and children and define the appropriate dose in order to optimize Montelukast&#xD;
      treatment in this vulnerable population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Anticipated">June 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>plasma concentration</measure>
    <time_frame>3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration</time_frame>
    <description>To detect the plasma concentrations of montelukast at 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>bronchoalveolar lavage fluid(BALF)</measure>
    <time_frame>Procedure (When the patient underwent fiberoptic bronchoscopy)</time_frame>
    <description>To detect the concentrations of montelukast in bronchoalveolar lavage fluid</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Asthma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Montelukast Chewable Tablet</intervention_name>
    <description>Montelukast treatment was used at a dosage of 5mg/day once daily</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients are cared in the department of pediatric respiratory at Shandong Provincial&#xD;
        Qianfoshan Hospital, Jinan, China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients have been diagnosed with asthma; age range: 1 month to 12 years old;&#xD;
             montelukast used as part of regular treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  expected survival time less than the treatment cycle; patients with other factors that&#xD;
             researcher considers unsuitable for inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Zhao, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shandong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wei Zhao, Ph.D</last_name>
    <phone>86053188383308</phone>
    <email>zhao4wei2@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shandong Provincial Qianfoshan Hospital</name>
      <address>
        <city>Ji'nan</city>
        <state>Shandong</state>
        <zip>250014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Zhao, Ph.D</last_name>
      <phone>86053188383308</phone>
      <email>zhao4wei2@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Wei Zhao</investigator_full_name>
    <investigator_title>Head of department of clinical pharmacy and pharmacology</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Montelukast</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03238560
org study id: 2016Montelukast001
nct id: NCT03238560
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The investigators' aim was to evaluate the population pharmacokinetics of montelukast in
      infants and children and define the appropriate dose in order to optimize Montelukast
      treatment in this vulnerable population.
observational model: Other
time perspective: Prospective
measure: plasma concentration
time frame: 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration
description: To detect the plasma concentrations of montelukast at 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration.
measure: bronchoalveolar lavage fluid(BALF)
time frame: Procedure (When the patient underwent fiberoptic bronchoscopy)
description: To detect the concentrations of montelukast in bronchoalveolar lavage fluid
intervention type: Drug
intervention name: Montelukast Chewable Tablet
description: Montelukast treatment was used at a dosage of 5mg/day once daily
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 12 Years
healthy volunteers: No
last name: Wei Zhao, Ph.D
role: Principal Investigator
affiliation: Shandong University
last name: Wei Zhao, Ph.D
phone: 86053188383308
email: zhao4wei2@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Wei Zhao
investigator title: Head of department of clinical pharmacy and pharmacology
mesh term: Montelukast
sharing ipd: Undecided