<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/NCT01704040</url>
  </required_header>
  <id_info>
    <org_study_id>CR100889</org_study_id>
    <secondary_id>CNTO3157ASH1002</secondary_id>
    <secondary_id>2011-005369-19</secondary_id>
    <nct_id>NCT01704040</nct_id>
  </id_info>
  <brief_title>A Study of CNTO 3157 in Healthy Normal and Asthmatic Participants Inoculated With Human Rhinovirus Type 16</brief_title>
  <official_title>A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating CNTO 3157 in Healthy Normal and Asthmatic Subjects Inoculated With Human Rhinovirus Type 16</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part&#xD;
      2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before&#xD;
      and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two-part, randomized (participants are assigned to treatment by chance),&#xD;
      double-blind (participants and investigators do not know what study agent is being&#xD;
      administered), placebo-controlled study. A placebo appears identical to a study agent, has no&#xD;
      active ingredients, and helps investigators evaluate the effect of a study agent. In Part 1,&#xD;
      following administration of CNTO 3157 or placebo, the severity of an upper respiratory tract&#xD;
      infection, due to inoculation with HRV 16, will be assessed in healthy participants for&#xD;
      safety reasons. In Part 2, following administration of CNTO 3157 or placebo and inoculation&#xD;
      with HRV-16, efficacy and safety will be assessed in asthmatic participants using standard&#xD;
      assessments to evaluate asthma treatments. The study (Parts 1 and 2) will be completed when&#xD;
      the last participant completes the last visit (Week 11) in Part 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The maximum percent decrease relative to baseline in the prebronchodilator forced expiratory volume in 1 second (FEV1) measurements (Part 2)</measure>
    <time_frame>Up to 10 days after inoculation with human rhinovirus type 16 (HRV-16)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the serum concentration versus time curve (AUC) of change from baseline in Cold Symptom Assessment Score</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
    <description>Cold symptoms is rated using a 5 point scale (0=none and 4=very severe). Scores can range from 0-32, with higher scores indicating more symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of change from baseline in Cold and Chest Symptom Scale</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
    <description>Cold and chest symptoms are rated using a 5 point scale: 0 using a 5 point scale (0=none and 4=very severe). Scores can range from 0-60, with higher scores indicating more symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of change from baseline in log-transformed fractional concentration of exhaled nitric oxide (FENO)</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of the percent change from baseline in clinic assessed prebronchodilator FEV1</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of change from baseline in morning (AM) peak expiratory flow rate (PEFR)</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of the change from baseline in prebronchodilator percent predicted FEV1</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of the change from baseline in prebronchodilator forced vital capacity (FVC)</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of the change from baseline in prebronchodilator forced expiratory flow at 25 to 75% of vital capacity (FEV25-75)</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of the change from baseline in prebronchodilator FEV1/FVC</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of change from baseline in average total asthma symptom diary score</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Asthma Control Questionnaire (ACQ)</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
    <description>ACQ is an instrument designed to evaluate asthma control. Seven items are scored on a 7-point scale (0=good control, 6=poor control) with the mean score as an overall summary score. Questions 1-6 are completed by the patient; the last item is entered by site personnel and corresponds to the patient's percent predicted FEV1 categorized according to the 7-point scale. Higher scores reflect poorer control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Cold Symptom Assessment Score</measure>
    <time_frame>Up to 11 weeks</time_frame>
    <description>Clinical symptoms to HRV-16 will be assessed by using the Cold Symptom Assessment Score, wherein participants will report the presence and severity of their cold symptoms in the context of the previous 24 hours via an interactive interview with the study staff. The symptoms consist of nasal congestion (stuffy nose), rhinorrhea (runny nose), sore throat, sneezing, cough, headache, malaise (feeling run down, tired) and chilliness. Severity is rated using a 5 point scale (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe). Scores can range from 0-32, with higher scores indicating more symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Cold and Chest Symptom Scale</measure>
    <time_frame>Up to 11 weeks</time_frame>
    <description>The Cold and Chest Symptom Scale contains 15 items composing 2 domains, a total cold score and a total chest score. Together, these 2 domains comprise the chest symptom assessment score.&#xD;
Total Cold Score domain: sneezing, runny nose, blocked or stuff nose, sore throat or hoarse voice, headache or face pain, generally unwell, chills, fever or shivery and cough and Total Chest Score domain: cough on waking, wheeze on waking, daytime cough, daytime wheeze, daytime chest tightness, daytime breathlessness and nocturnal cough, wheeze and breathlessness.&#xD;
Severity is rated using a 5 point scale: 0 using a 5 point scale (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe). Scores can range from 0-60, with higher scores indicating more symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in log-transformed FENO over time</measure>
    <time_frame>Up to 11 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline over time in prebronchodilator and postbronchodilator FEV1</measure>
    <time_frame>Up to 11 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline over time in percent-predicted prebronchodilator and postbronchodilator FEV1</measure>
    <time_frame>Up to 11 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline over time in prebronchodilator and postbronchodilator FVC</measure>
    <time_frame>Up to 11 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline over time in prebronchodilator and postbronchodilator FEV25-75</measure>
    <time_frame>Up to 11 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline over time in prebronchodilator and postbronchodilator FEV1/FVC</measure>
    <time_frame>Up to 11 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in morning/evening PEFR over time</measure>
    <time_frame>Up to 11 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Total Nasal and Ocular Symptom Score (TNOSS)</measure>
    <time_frame>Up to Day 22</time_frame>
    <description>Nose and eye symptoms are rated by the patient using a 5-point categorical response scale from 0 to 4, where 0 indicates absent/no symptom, and 4 indicates extremely severe symptoms, with a 24-hour recall period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in average total asthma symptom diary score</measure>
    <time_frame>Up to 11 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in average number of nocturnal awakenings</measure>
    <time_frame>Up to 11 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in average rescue medication use over time</measure>
    <time_frame>Up to 11 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of symptom-free days</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The maximum decrease from baseline in the prebronchodilator FEV1 measurements</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to the maximum decrease relative to baseline in prebronchodilator FEV1</measure>
    <time_frame>Up to 10 days after inoculation with HRV-16</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Healthy Volunteers and Asthma</condition>
  <arm_group>
    <arm_group_label>Part 1: Healthy participants (CNTO 3157 + HRV-16)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Healthy participants (placebo + HRV-16)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Asthmatic patients (CNTO 3157 + HRV-16)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Asthmatic patients (placebo + HRV-16)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CNTO 3157 (healthy participants)</intervention_name>
    <description>CNTO 3157 10 mg/kg, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with human rhinovirus type 16 (HRV-16).</description>
    <arm_group_label>Part 1: Healthy participants (CNTO 3157 + HRV-16)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (healthy participants)</intervention_name>
    <description>Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16.</description>
    <arm_group_label>Part 1: Healthy participants (placebo + HRV-16)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CNTO 3157 (asthmatic patients)</intervention_name>
    <description>CNTO 3157 10 mg/kg, as a single intravenous infusion, at Week 1 (Day 1), followed by 3 infusions of 3 mg/kg of CNTO 3157 at Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.</description>
    <arm_group_label>Part 2: Asthmatic patients (CNTO 3157 + HRV-16)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (asthmatic patients)</intervention_name>
    <description>Placebo, as 4 intravenous infusions, at Week 1 (Day 1), Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.</description>
    <arm_group_label>Part 2: Asthmatic patients (placebo + HRV-16)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HRV-16</intervention_name>
    <description>Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.</description>
    <arm_group_label>Part 1: Healthy participants (CNTO 3157 + HRV-16)</arm_group_label>
    <arm_group_label>Part 1: Healthy participants (placebo + HRV-16)</arm_group_label>
    <arm_group_label>Part 2: Asthmatic patients (CNTO 3157 + HRV-16)</arm_group_label>
    <arm_group_label>Part 2: Asthmatic patients (placebo + HRV-16)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Understanding of the study and a signed informed consent form before any study-related&#xD;
             procedures&#xD;
&#xD;
          -  Willing and able to adhere to the restrictions specified in the protocol&#xD;
&#xD;
          -  Results of the following laboratory tests within the following limits: serum alanine&#xD;
             aminotransferase (ALT) levels ≤2 x ULN; serum aspartate aminotransferase (AST) levels&#xD;
             ≤2 x ULN&#xD;
&#xD;
          -  Part 1 (healthy participants):&#xD;
&#xD;
          -  a). Body weight in the range of 40 to 125 kg, inclusive. Have a body mass index (BMI)&#xD;
             of 19 to 32 kg/m2, inclusive&#xD;
&#xD;
          -  b). Healthy with no clinically significant abnormalities as determined by medical&#xD;
             history, physical examination, blood chemistry assessments, hematologic assessments,&#xD;
             coagulation and urinalysis, measurement of vital signs, and 12-lead electrocardiogram&#xD;
             (ECG) performed at Screening Visit 2&#xD;
&#xD;
          -  Part 2:&#xD;
&#xD;
          -  a). (BMI) of 19 to 40 kg/m2, inclusive; have a physician-documented diagnosis of&#xD;
             asthma for at least 6 months prior to Screening Visit 2; have stable asthma based on&#xD;
             physician assessment at Screening Visit 2&#xD;
&#xD;
          -  b). Have an Asthma Control Questionnaire (ACQ) symptom score less than (&lt;)2.5 at&#xD;
             Screening Visit 2&#xD;
&#xD;
          -  c). Have a prebronchodilator forced expiratory volume in the first second (FEV1)&#xD;
             greater than or equal to (&gt;=) 65 percent of predicted normal value at Screening Visit&#xD;
             2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Part 1 (healthy participants): Has any condition that in the opinion of the&#xD;
             investigators, would constitute a risk or a contraindication for participating in the&#xD;
             study, prevent the participant from meeting or performing study requirements, or could&#xD;
             interfere with the study objectives, conduct, or evaluation&#xD;
&#xD;
          -  At Screening Visit 1 and throughout the study, works with (or lives with a family&#xD;
             member who cares for) the elderly, (eg, nursing home), or lives with someone who may&#xD;
             be at risk from transmission of the human rhinovirus type 16 (HRV-16) challenge agent,&#xD;
             including, but not limited to, individuals with chronic lung disease (including&#xD;
             asthma), a premature infant, or an immunocompromised individual&#xD;
&#xD;
          -  Has had any acute illness, including a common cold, within 4 weeks prior to Screening&#xD;
             Visit 1, or has had a major illness or hospitalization within 6 months prior to&#xD;
             Screening Visit 1&#xD;
&#xD;
          -  Has active allergic rhinitis or perennial allergy symptoms (eg, due to ragweed) at&#xD;
             Screening Visit 2 or expects to have active allergic rhinitis or perennial allergy&#xD;
             symptoms during the study&#xD;
&#xD;
          -  Has a current infection (eg, sepsis, pneumonia or pyelonephritis), or has been&#xD;
             hospitalized and/or received antimicrobials for a serious infection during the 6&#xD;
             months prior to Screening Visit 1&#xD;
&#xD;
          -  Part 2 (asthmatic patients): Has a history of any other chronic lung disease,&#xD;
             including chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis,&#xD;
             allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea,&#xD;
             pulmonary hypertension, or any other obstructive pulmonary disease, liver or renal&#xD;
             insufficiency; significant unstable cardiac, vascular, pulmonary, gastrointestinal,&#xD;
             endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic&#xD;
             disturbances, or other body system disorders that are clinically significant in the&#xD;
             opinion of the investigator&#xD;
&#xD;
          -  Has ever had an episode of life-threatening asthma defined as respiratory arrest or&#xD;
             requiring intubation for asthma&#xD;
&#xD;
          -  Has been hospitalized (for greater than 24 hours) due to asthma in the 5 years prior&#xD;
             to Screening Visit 1&#xD;
&#xD;
          -  Has experienced an asthma exacerbation in the 12 weeks prior to Screening Visit 1&#xD;
             requiring management with systemic steroids&#xD;
&#xD;
          -  Is receiving a high-dose inhaled corticosteroid (ICS) (&gt;500 µg/day to fluticasone or&#xD;
             equivalent). Use of low or medium dose ICS (≤500 µg/day fluticasone or equivalent)&#xD;
             with or without permitted controller medications, eg, long-acting Beta2 agonists&#xD;
             (LABA), leukotriene receptor antagonists (LTRA), is allowed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hellerup</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kobenhavn Nv</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Borstel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Amsterdam Zuidoost</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Belfast</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dundee</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>December 11, 2014</last_update_submitted>
  <last_update_submitted_qc>December 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy volunteers and asthma</keyword>
  <keyword>CNTO 3157</keyword>
  <keyword>Rhinovirus</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/NCT01704040
org study id: CR100889
secondary id: CNTO3157ASH1002
secondary id: 2011-005369-19
nct id: NCT01704040
lead sponsor: 
has dmc: Yes
The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part
      2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before
      and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).
This is a two-part, randomized (participants are assigned to treatment by chance),
      double-blind (participants and investigators do not know what study agent is being
      administered), placebo-controlled study. A placebo appears identical to a study agent, has no
      active ingredients, and helps investigators evaluate the effect of a study agent. In Part 1,
      following administration of CNTO 3157 or placebo, the severity of an upper respiratory tract
      infection, due to inoculation with HRV 16, will be assessed in healthy participants for
      safety reasons. In Part 2, following administration of CNTO 3157 or placebo and inoculation
      with HRV-16, efficacy and safety will be assessed in asthmatic participants using standard
      assessments to evaluate asthma treatments. The study (Parts 1 and 2) will be completed when
      the last participant completes the last visit (Week 11) in Part 2.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: The maximum percent decrease relative to baseline in the prebronchodilator forced expiratory volume in 1 second (FEV1) measurements (Part 2)
time frame: Up to 10 days after inoculation with human rhinovirus type 16 (HRV-16)
measure: Area under the serum concentration versus time curve (AUC) of change from baseline in Cold Symptom Assessment Score
time frame: Up to 10 days after inoculation with HRV-16
description: Cold symptoms is rated using a 5 point scale (0=none and 4=very severe). Scores can range from 0-32, with higher scores indicating more symptoms.
measure: AUC of change from baseline in Cold and Chest Symptom Scale
time frame: Up to 10 days after inoculation with HRV-16
description: Cold and chest symptoms are rated using a 5 point scale: 0 using a 5 point scale (0=none and 4=very severe). Scores can range from 0-60, with higher scores indicating more symptoms.
measure: AUC of change from baseline in log-transformed fractional concentration of exhaled nitric oxide (FENO)
time frame: Up to 10 days after inoculation with HRV-16
measure: AUC of the percent change from baseline in clinic assessed prebronchodilator FEV1
time frame: Up to 10 days after inoculation with HRV-16
measure: AUC of change from baseline in morning (AM) peak expiratory flow rate (PEFR)
time frame: Up to 10 days after inoculation with HRV-16
measure: AUC of the change from baseline in prebronchodilator percent predicted FEV1
time frame: Up to 10 days after inoculation with HRV-16
measure: AUC of the change from baseline in prebronchodilator forced vital capacity (FVC)
time frame: Up to 10 days after inoculation with HRV-16
measure: AUC of the change from baseline in prebronchodilator forced expiratory flow at 25 to 75% of vital capacity (FEV25-75)
time frame: Up to 10 days after inoculation with HRV-16
measure: AUC of the change from baseline in prebronchodilator FEV1/FVC
time frame: Up to 10 days after inoculation with HRV-16
measure: AUC of change from baseline in average total asthma symptom diary score
time frame: Up to 10 days after inoculation with HRV-16
measure: Change from baseline in Asthma Control Questionnaire (ACQ)
time frame: Up to 10 days after inoculation with HRV-16
description: ACQ is an instrument designed to evaluate asthma control. Seven items are scored on a 7-point scale (0=good control, 6=poor control) with the mean score as an overall summary score. Questions 1-6 are completed by the patient; the last item is entered by site personnel and corresponds to the patient's percent predicted FEV1 categorized according to the 7-point scale. Higher scores reflect poorer control.
measure: Change from baseline in Cold Symptom Assessment Score
time frame: Up to 11 weeks
description: Clinical symptoms to HRV-16 will be assessed by using the Cold Symptom Assessment Score, wherein participants will report the presence and severity of their cold symptoms in the context of the previous 24 hours via an interactive interview with the study staff. The symptoms consist of nasal congestion (stuffy nose), rhinorrhea (runny nose), sore throat, sneezing, cough, headache, malaise (feeling run down, tired) and chilliness. Severity is rated using a 5 point scale (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe). Scores can range from 0-32, with higher scores indicating more symptoms.
measure: Change from baseline in Cold and Chest Symptom Scale
time frame: Up to 11 weeks
description: The Cold and Chest Symptom Scale contains 15 items composing 2 domains, a total cold score and a total chest score. Together, these 2 domains comprise the chest symptom assessment score.
Total Cold Score domain: sneezing, runny nose, blocked or stuff nose, sore throat or hoarse voice, headache or face pain, generally unwell, chills, fever or shivery and cough and Total Chest Score domain: cough on waking, wheeze on waking, daytime cough, daytime wheeze, daytime chest tightness, daytime breathlessness and nocturnal cough, wheeze and breathlessness.
Severity is rated using a 5 point scale: 0 using a 5 point scale (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe). Scores can range from 0-60, with higher scores indicating more symptoms.
measure: Change from baseline in log-transformed FENO over time
time frame: Up to 11 weeks
measure: Change from baseline over time in prebronchodilator and postbronchodilator FEV1
time frame: Up to 11 weeks
measure: Change from baseline over time in percent-predicted prebronchodilator and postbronchodilator FEV1
time frame: Up to 11 weeks
measure: Change from baseline over time in prebronchodilator and postbronchodilator FVC
time frame: Up to 11 weeks
measure: Change from baseline over time in prebronchodilator and postbronchodilator FEV25-75
time frame: Up to 11 weeks
measure: Change from baseline over time in prebronchodilator and postbronchodilator FEV1/FVC
time frame: Up to 11 weeks
measure: Change from baseline in morning/evening PEFR over time
time frame: Up to 11 weeks
measure: Change from baseline in Total Nasal and Ocular Symptom Score (TNOSS)
time frame: Up to Day 22
description: Nose and eye symptoms are rated by the patient using a 5-point categorical response scale from 0 to 4, where 0 indicates absent/no symptom, and 4 indicates extremely severe symptoms, with a 24-hour recall period.
measure: Change from baseline in average total asthma symptom diary score
time frame: Up to 11 weeks
measure: Change from baseline in average number of nocturnal awakenings
time frame: Up to 11 weeks
measure: Change from baseline in average rescue medication use over time
time frame: Up to 11 weeks
measure: Number of symptom-free days
time frame: Up to 10 days after inoculation with HRV-16
measure: The maximum decrease from baseline in the prebronchodilator FEV1 measurements
time frame: Up to 10 days after inoculation with HRV-16
measure: Time to the maximum decrease relative to baseline in prebronchodilator FEV1
time frame: Up to 10 days after inoculation with HRV-16
arm group label: Part 1: Healthy participants (CNTO 3157 + HRV-16)
arm group type: Experimental
arm group label: Part 1: Healthy participants (placebo + HRV-16)
arm group type: Placebo Comparator
arm group label: Part 2: Asthmatic patients (CNTO 3157 + HRV-16)
arm group type: Experimental
arm group label: Part 2: Asthmatic patients (placebo + HRV-16)
arm group type: Placebo Comparator
intervention type: Drug
intervention name: CNTO 3157 (healthy participants)
description: CNTO 3157 10 mg/kg, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with human rhinovirus type 16 (HRV-16).
arm group label: Part 1: Healthy participants (CNTO 3157 + HRV-16)
intervention type: Drug
intervention name: Placebo (healthy participants)
description: Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16.
arm group label: Part 1: Healthy participants (placebo + HRV-16)
intervention type: Drug
intervention name: CNTO 3157 (asthmatic patients)
description: CNTO 3157 10 mg/kg, as a single intravenous infusion, at Week 1 (Day 1), followed by 3 infusions of 3 mg/kg of CNTO 3157 at Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.
arm group label: Part 2: Asthmatic patients (CNTO 3157 + HRV-16)
intervention type: Drug
intervention name: Placebo (asthmatic patients)
description: Placebo, as 4 intravenous infusions, at Week 1 (Day 1), Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.
arm group label: Part 2: Asthmatic patients (placebo + HRV-16)
intervention type: Other
intervention name: HRV-16
description: Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
arm group label: Part 1: Healthy participants (CNTO 3157 + HRV-16)
arm group label: Part 1: Healthy participants (placebo + HRV-16)
arm group label: Part 2: Asthmatic patients (CNTO 3157 + HRV-16)
arm group label: Part 2: Asthmatic patients (placebo + HRV-16)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: Belgium
country: Canada
country: Denmark
country: Germany
country: Netherlands
country: United Kingdom
responsible party type: Sponsor
mesh term: Asthma