<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/NCT01676467</url>
  </required_header>
  <id_info>
    <org_study_id>ENA002</org_study_id>
    <nct_id>NCT01676467</nct_id>
  </id_info>
  <brief_title>Sample Collection in Smoking Asthma</brief_title>
  <official_title>A Sample Collection Protocol for Disease Profiling of Smoking Asthma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Respivert Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Respivert Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will collect blood and sputum (phlegm) samples from subjects with asthma, smokers&#xD;
      and normal healthy subjects, to compare the biological markers of disease and inflammation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sputum and serum biomarkers</measure>
    <time_frame>Day 10</time_frame>
    <description>Measurement of biomarkers of inflammation, including but not limited to: TNFα, IL-8, IFNγ, IP10 and eotaxin in sputum supernatant and serum will be collected and measured only once, at Visit 2 (Day 10).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sputum cell count</measure>
    <time_frame>Day 10</time_frame>
    <description>Sputum cell count (total cells, differentials and absolute number) at Visit 2 (Day 10).</description>
  </primary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Smoking asthma on steroids</arm_group_label>
    <description>Smokers with persistent asthma on background steroid therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smoking asthma steroid naïve</arm_group_label>
    <description>Smokers with persistent asthma, steroid naive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>asthma on steroids</arm_group_label>
    <description>Non-Smokers with persistent asthma on background steroid therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>asthma, steroid naïve</arm_group_label>
    <description>Non-smokers with persistent asthma, steroid naive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy smoking</arm_group_label>
    <description>Healthy smoking control subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy non-smoking</arm_group_label>
    <description>Healthy non-smoking control subjects</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum sputum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be selected by advertisements from the general population and primary care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (healthy subjects):&#xD;
&#xD;
          -  Male or female, between 18 and 55 years of age, inclusive.&#xD;
&#xD;
          -  no clinically significant abnormalities.&#xD;
&#xD;
          -  able to produce an adequate induced sputum sample.&#xD;
&#xD;
          -  no history of chronic respiratory disease including asthma.&#xD;
&#xD;
          -  no history of allergic symptoms e.g., allergic rhinitis, eczema.&#xD;
&#xD;
          -  No other acute illness in the 6 weeks prior to Visit 1.&#xD;
&#xD;
        Additional Inclusion Criterion for Healthy Smoking Subjects&#xD;
&#xD;
          -  Be a smoker for &gt;/= 1 year.&#xD;
&#xD;
        Additional Inclusion Criteria (Persistent Asthmatic Subjects):&#xD;
&#xD;
          -  No contraindications to the procedures in this study.&#xD;
&#xD;
          -  Symptoms compatible with asthma for at least 6 months prior to screening&#xD;
&#xD;
          -  Pre-bronchodilator FEV1 &gt;/=50% predicted at Visit 1.&#xD;
&#xD;
          -  clinically stable asthma for at least 6 weeks prior to Visit 1.&#xD;
&#xD;
          -  No acute illness including asthma exacerbation requiring augmentation of therapy in&#xD;
             the 6 weeks prior to Visit 1.&#xD;
&#xD;
          -  on current asthma controller therapy for &gt;/= 6 weeks prior to Visit 1.&#xD;
&#xD;
        Additional Inclusion for Steroid Naïve Asthmatics (smoking or non-smoking)&#xD;
&#xD;
          -  Must not have received a regular course of inhaled or oral corticosteroids for at&#xD;
             least 3 months prior to Visit 1.&#xD;
&#xD;
        Additional Inclusion for Smoking Asthmatics&#xD;
&#xD;
          -  Be a smoker for &gt;/= 1 year prior to Visit 1.&#xD;
&#xD;
        Exclusion Criteria (healthy):&#xD;
&#xD;
          -  History of any clinically significant medical illness or medical disorders.&#xD;
&#xD;
          -  Diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or other&#xD;
             significant respiratory disorder including significant occupational or environmental&#xD;
             exposures with ongoing respiratory symptoms.&#xD;
&#xD;
          -  bronchodilator response of &gt;/=12% and at least 200 mL from baseline or an FEV1 value&#xD;
             &lt;85% of predicted value at Visit 1.&#xD;
&#xD;
          -  positive urine pregnancy screening result.&#xD;
&#xD;
          -  recent history (within previous 6 months) of alcohol or drug abuse.&#xD;
&#xD;
          -  Positive urine toxicology screen for substances of abuse&#xD;
&#xD;
          -  positive serology test for HIV antibodies, hepatitis B surface antigen (HBsAg), or&#xD;
             hepatitis C virus antibody (anti-HCV) at Visit 1.&#xD;
&#xD;
          -  Received an experimental antibody or biologic therapy within the 6 months prior to&#xD;
             Visit 1, or received any other experimental therapy or new investigational agent&#xD;
             within 60 days of Visit 1.&#xD;
&#xD;
          -  Is an employee or family member of the investigator, study centre or Sponsor.&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, would complicate or compromise&#xD;
             the study, or the well-being of the subject.&#xD;
&#xD;
          -  Use of any antioxidants within 1 week of Visit 1 and throughout the study period.&#xD;
&#xD;
          -  known allergies, hypersensitivity, or intolerance to short acting β-agonists (SABA).&#xD;
&#xD;
        Additional Exclusion Criterion for Healthy Non-smoking Subjects&#xD;
&#xD;
          -  subject is a smoker (regular or irregular), or has smoked or used nicotine-containing&#xD;
             products within the 6 months prior to Visit 1.&#xD;
&#xD;
        Additional Exclusion Criteria (Persistent Asthma Subjects):&#xD;
&#xD;
          -  Diagnosis of allergic bronchopulmonary aspergillosis (ABPA), allergic bronchopulmonary&#xD;
             mycosis (ABPM), or occupational asthma.&#xD;
&#xD;
          -  Diagnosis of COPD, cystic fibrosis, or other significant respiratory disorder&#xD;
             including significant occupational or environmental exposures with ongoing respiratory&#xD;
             symptoms.&#xD;
&#xD;
          -  Use of theophylline, N-acetyl cysteine, or any other anti-oxidants within 1 week of&#xD;
             Visit 1 and throughout the study period.&#xD;
&#xD;
          -  positive test for tuberculosis at Visit 1.&#xD;
&#xD;
        Additional Exclusion Criterion for Non-smoking Asthmatic Subjects&#xD;
&#xD;
          -  subject is a smoker (regular or irregular), or has smoked or used nicotine-containing&#xD;
             products within the 6 months prior to Visit 1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Garth Rapeport</last_name>
    <role>Study Director</role>
    <affiliation>Respivert Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Harrow</city>
        <state>Middlesex</state>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>January 7, 2013</last_update_submitted>
  <last_update_submitted_qc>January 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 8, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT01676467
org study id: ENA002
nct id: NCT01676467
lead sponsor: 
has dmc: No
This study will collect blood and sputum (phlegm) samples from subjects with asthma, smokers
      and normal healthy subjects, to compare the biological markers of disease and inflammation.
observational model: Cohort
time perspective: Cross-Sectional
measure: Sputum and serum biomarkers
time frame: Day 10
description: Measurement of biomarkers of inflammation, including but not limited to: TNFα, IL-8, IFNγ, IP10 and eotaxin in sputum supernatant and serum will be collected and measured only once, at Visit 2 (Day 10).
measure: Sputum cell count
time frame: Day 10
description: Sputum cell count (total cells, differentials and absolute number) at Visit 2 (Day 10).
arm group label: Smoking asthma on steroids
description: Smokers with persistent asthma on background steroid therapy
arm group label: Smoking asthma steroid naïve
description: Smokers with persistent asthma, steroid naive
arm group label: asthma on steroids
description: Non-Smokers with persistent asthma on background steroid therapy
arm group label: asthma, steroid naïve
description: Non-smokers with persistent asthma, steroid naive
arm group label: Healthy smoking
description: Healthy smoking control subjects
arm group label: Healthy non-smoking
description: Healthy non-smoking control subjects
serum sputum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr Garth Rapeport
role: Study Director
affiliation: Respivert Ltd
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Asthma