<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/NCT01681732</url>
  </required_header>
  <id_info>
    <org_study_id>38403</org_study_id>
    <nct_id>NCT01681732</nct_id>
  </id_info>
  <brief_title>A Pilot Study of Personalized Medicine for Pediatric Asthma</brief_title>
  <official_title>A Pilot Study of Personalized Medicine for Pediatric Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A pilot study to test the feasibility of a personalized asthma care intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are two arms in this study. The control arm of the trial will involve the current&#xD;
      standard primary care asthma management, and the intervention arm will involve personalized&#xD;
      asthma management.&#xD;
&#xD;
      Inclusion criteria include: 1) child age 6-17 years, 2) doctor diagnosed asthma, 3) at least&#xD;
      one asthma exacerbation in the previous year. Children with other coexistent pulmonary&#xD;
      diseases such as chronic lung disease and cystic fibrosis will be excluded.&#xD;
&#xD;
      The period of participation will be three months for each participant. After screening, each&#xD;
      participant will have an initial clinic visit. During this baseline visit, the investigators&#xD;
      will collect DNA by taking a saliva sample, the investigators will conduct spirometry, and&#xD;
      the investigators will survey the families regarding household level environmental exposures,&#xD;
      demographics, and other key variables. The participant will be randomly assigned to a study&#xD;
      arm at the end of the baseline visit. The data gathered at the baseline visit will be used to&#xD;
      develop a management plan. The investigators will mail a plan to the participant and the&#xD;
      primary care provider within a couple weeks of the baseline visit. The investigators will&#xD;
      then discuss the plan with the participant via phone. Both groups will receive a plan which&#xD;
      MAY be used to guide asthma care. Sample letters follow the protocol. The intervention group&#xD;
      will receive basic information on the skin testing, genetic testing, and spirometry. The&#xD;
      control group will not receive the genetic information. The control arm will receive the&#xD;
      genetic information at the end of the study follow up.&#xD;
&#xD;
      After the baseline visit, the participants will receive a monthly phone call for two months&#xD;
      to conduct a survey to assess our study outcomes and covariates. At the 3rd month&#xD;
      participants will return to the GCRC for a final clinic visit. During the final visit the&#xD;
      investigators will conduct our survey and spirometry and request permission for medical&#xD;
      record release.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 29, 2014</completion_date>
  <primary_completion_date type="Actual">August 29, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of symptom free days over the course of the study</measure>
    <time_frame>3 months</time_frame>
    <description>measured as the number of days during the 2 weeks before the follow-up interview with no asthma symptoms</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Personalized Care Plan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A personalized plan based on baseline clinic visit data</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will be standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personalized Care Plan</intervention_name>
    <description>We will develop a personalized plan based on info collected in the primary visit</description>
    <arm_group_label>Personalized Care Plan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Standard Care</intervention_name>
    <description>This is the standard care arm</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 6-17 years&#xD;
&#xD;
          -  doctor diagnosed asthma -at least one asthma exacerbation in the previous year. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Children with other coexistent pulmonary diseases such as chronic lung disease and cystic&#xD;
        fibrosis will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam Spanier, MD, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Milton S. Hershey Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State Hershey Children's Hospital</name>
      <address>
        <city>Hersey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>March 31, 2017</last_update_submitted>
  <last_update_submitted_qc>March 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>child</keyword>
  <keyword>pediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01681732
org study id: 38403
nct id: NCT01681732
lead sponsor: 
has dmc: No
A pilot study to test the feasibility of a personalized asthma care intervention.
There are two arms in this study. The control arm of the trial will involve the current
      standard primary care asthma management, and the intervention arm will involve personalized
      asthma management.

      Inclusion criteria include: 1) child age 6-17 years, 2) doctor diagnosed asthma, 3) at least
      one asthma exacerbation in the previous year. Children with other coexistent pulmonary
      diseases such as chronic lung disease and cystic fibrosis will be excluded.

      The period of participation will be three months for each participant. After screening, each
      participant will have an initial clinic visit. During this baseline visit, the investigators
      will collect DNA by taking a saliva sample, the investigators will conduct spirometry, and
      the investigators will survey the families regarding household level environmental exposures,
      demographics, and other key variables. The participant will be randomly assigned to a study
      arm at the end of the baseline visit. The data gathered at the baseline visit will be used to
      develop a management plan. The investigators will mail a plan to the participant and the
      primary care provider within a couple weeks of the baseline visit. The investigators will
      then discuss the plan with the participant via phone. Both groups will receive a plan which
      MAY be used to guide asthma care. Sample letters follow the protocol. The intervention group
      will receive basic information on the skin testing, genetic testing, and spirometry. The
      control group will not receive the genetic information. The control arm will receive the
      genetic information at the end of the study follow up.

      After the baseline visit, the participants will receive a monthly phone call for two months
      to conduct a survey to assess our study outcomes and covariates. At the 3rd month
      participants will return to the GCRC for a final clinic visit. During the final visit the
      investigators will conduct our survey and spirometry and request permission for medical
      record release.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: number of symptom free days over the course of the study
time frame: 3 months
description: measured as the number of days during the 2 weeks before the follow-up interview with no asthma symptoms
arm group label: Personalized Care Plan
arm group type: Experimental
description: A personalized plan based on baseline clinic visit data
arm group label: Control
arm group type: Active Comparator
description: This arm will be standard care
intervention type: Other
intervention name: Personalized Care Plan
description: We will develop a personalized plan based on info collected in the primary visit
arm group label: Personalized Care Plan
intervention type: Other
intervention name: Control Standard Care
description: This is the standard care arm
arm group label: Control
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Adam Spanier, MD, PhD, MPH
role: Principal Investigator
affiliation: Milton S. Hershey Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No