<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/NCT01690793</url>
  </required_header>
  <id_info>
    <org_study_id>acute asthma</org_study_id>
    <nct_id>NCT01690793</nct_id>
  </id_info>
  <brief_title>Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma</brief_title>
  <acronym>acute asthma</acronym>
  <official_title>Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of South Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that there is a statistically significant decrease of&#xD;
      Natriuretic Hormone Peptides (NHPs) in subjects with asthma exacerbation compared to levels&#xD;
      following treatment of an exacerbation of asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overall Study Design&#xD;
&#xD;
        1. Measurement of Natriuretic Hormone Peptides in individuals suffering from exacerbation&#xD;
           of asthma.&#xD;
&#xD;
        2. Measurement of Natriuretic Hormone Peptides 5-7 days after initiation of treatment of&#xD;
           exacerbation of asthma.&#xD;
&#xD;
        3. Measurement of Natriuretic Hormone Peptides 10-14 days after initiation of treatment of&#xD;
           exacerbation of asthma.&#xD;
&#xD;
      3 comparisons of Natriuretic Hormone Peptides levels will be made:&#xD;
&#xD;
        1. Exacerbation compared to 5-7 days after initiation of treatment&#xD;
&#xD;
        2. Exacerbation compared to 10-14 days after initiation of treatment&#xD;
&#xD;
        3. 5-7 days after initiation of treatment compared to 10-14 days after initiation of&#xD;
           treatment.&#xD;
&#xD;
      Samples of blood will be secured in the Division of Allergy/Immunology at the University of&#xD;
      South Florida, Joy McCann Culverhouse Airways Disease Center. All samples will be&#xD;
      appropriately coded to maintain confidentiality. Blood specimens will be held at minus 20&#xD;
      degrees Celsius.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2009</start_date>
  <completion_date type="Actual">February 2011</completion_date>
  <primary_completion_date type="Actual">December 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>The measurement of NHPs after treatment of an exacerbation of asthma</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>ASTHMA</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples of blood will be secured in the Division of Allergy/Immunology at the University of&#xD;
      South Florida, Joy McCann Culverhouse Airways Disease Center. All samples will be&#xD;
      appropriately coded to maintain confidentiality. Blood specimens will be held at minus 20&#xD;
      degrees Celsius. GENETICS SAMPLES ARE OPTIONAL&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The Asthma Control Test score of less than 18.&#xD;
&#xD;
        Asthma control test consists of five questions, scored 1-5 each.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both genders, age 18-85.&#xD;
&#xD;
          -  Females who are pregnant or lactating are not eligible.&#xD;
&#xD;
          -  Read and comprehend English.&#xD;
&#xD;
          -  Ability to give informed consent.&#xD;
&#xD;
          -  Seen in the outpatient setting at one of the clinic.&#xD;
&#xD;
          -  The subject must have a history of physician diagnosed asthma for at least 1 year and&#xD;
             must have an exacerbation of asthma for entry into the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Usf Asthma Allergy and Immunology Cru</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 5, 2010</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>May 27, 2015</last_update_submitted>
  <last_update_submitted_qc>May 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of South Florida</investigator_affiliation>
    <investigator_full_name>Richard Lockey</investigator_full_name>
    <investigator_title>prinicpal investigator</investigator_title>
  </responsible_party>
  <keyword>ASTHMA</keyword>
  <keyword>ACUTE EXACERBATION OF ASTHMA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_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/NCT01690793
org study id: acute asthma
nct id: NCT01690793
lead sponsor: 
has dmc: No
The investigators hypothesize that there is a statistically significant decrease of
      Natriuretic Hormone Peptides (NHPs) in subjects with asthma exacerbation compared to levels
      following treatment of an exacerbation of asthma.
Overall Study Design

        1. Measurement of Natriuretic Hormone Peptides in individuals suffering from exacerbation
           of asthma.

        2. Measurement of Natriuretic Hormone Peptides 5-7 days after initiation of treatment of
           exacerbation of asthma.

        3. Measurement of Natriuretic Hormone Peptides 10-14 days after initiation of treatment of
           exacerbation of asthma.

      3 comparisons of Natriuretic Hormone Peptides levels will be made:

        1. Exacerbation compared to 5-7 days after initiation of treatment

        2. Exacerbation compared to 10-14 days after initiation of treatment

        3. 5-7 days after initiation of treatment compared to 10-14 days after initiation of
           treatment.

      Samples of blood will be secured in the Division of Allergy/Immunology at the University of
      South Florida, Joy McCann Culverhouse Airways Disease Center. All samples will be
      appropriately coded to maintain confidentiality. Blood specimens will be held at minus 20
      degrees Celsius.
measure: The measurement of NHPs after treatment of an exacerbation of asthma
time frame: 14 days
Samples of blood will be secured in the Division of Allergy/Immunology at the University of
      South Florida, Joy McCann Culverhouse Airways Disease Center. All samples will be
      appropriately coded to maintain confidentiality. Blood specimens will be held at minus 20
      degrees Celsius. GENETICS SAMPLES ARE OPTIONAL
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of South Florida
investigator full name: Richard Lockey
investigator title: prinicpal investigator
mesh term: Asthma