<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/NCT01715493</url>
  </required_header>
  <id_info>
    <org_study_id>LYS-0003</org_study_id>
    <nct_id>NCT01715493</nct_id>
  </id_info>
  <brief_title>Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom</brief_title>
  <official_title>Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom: a Randomised Placebo-controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to assess the effectiveness for small airway inflammation of 4&#xD;
      weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of several inflammatory or biochemical marker concentration in inducted sputum</measure>
    <time_frame>8 weeks (2 periods each lasting 4 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration.</measure>
    <time_frame>8 weeks (2 periods each lasting 4 weeks)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Monthly reduction in forced expiratory volume in 1 Second (FEV1)</measure>
    <time_frame>8 weeks (2 periods each lasting 4 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test)</measure>
    <time_frame>8 weeks (2 periods each lasting 4 weeks)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Lysozyme 90 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lysozyme 90 mg</intervention_name>
    <description>Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)</description>
    <arm_group_label>Lysozyme 90 mg</arm_group_label>
    <other_name>PRT10T</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Lysozyme Matching Placebo three times daily for 4 weeks followed by Lysozyme 90 mg three times daily for 4 weeks (plus usual COPD medication)</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>PRT10T</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        For COPD:&#xD;
&#xD;
          -  Over 20 years of age and below 85 years of age&#xD;
&#xD;
          -  Smoking history&#xD;
&#xD;
          -  Brinkman index 200 or more&#xD;
&#xD;
          -  Diagnosis of COPD&#xD;
&#xD;
          -  Forced expiratory volume in 1 second (FEV1) of &lt;80% of the predicted value&#xD;
&#xD;
          -  Ratio of FEV1 to forced vital capacity (FVC) of &lt;70%&#xD;
&#xD;
          -  symptom of expectorated sputum&#xD;
&#xD;
        For Asthma&#xD;
&#xD;
          -  Over 20 years of age and below 85 years of age&#xD;
&#xD;
          -  Scored between 20 to 24 by ACT (Asthma Control Test)&#xD;
&#xD;
          -  Symptom of expectorated sputum&#xD;
&#xD;
          -  Diagnosed partly controlled by global initiative for asthma&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Egg allergy&#xD;
&#xD;
          -  Domiciliary oxygen therapy&#xD;
&#xD;
          -  Pneumonia or pulmonary tuberculosis&#xD;
&#xD;
          -  Patients with severe cardiovascular disorder, severe kidney disorder, severe hepatic&#xD;
             disorder, severe hematological disorder&#xD;
&#xD;
          -  Cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kai Shibata</last_name>
    <role>Study Director</role>
    <affiliation>Drug Fostering and Evoluation Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquaters</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Mizunami</city>
        <state>Gifu</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Asthma</keyword>
  <keyword>Lysozyme Hydrochloride</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muramidase</mesh_term>
  </intervention_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/NCT01715493
org study id: LYS-0003
nct id: NCT01715493
lead sponsor: 
has dmc: No
The aim of this study was to assess the effectiveness for small airway inflammation of 4
      weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change of several inflammatory or biochemical marker concentration in inducted sputum
time frame: 8 weeks (2 periods each lasting 4 weeks)
measure: Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration.
time frame: 8 weeks (2 periods each lasting 4 weeks)
measure: Monthly reduction in forced expiratory volume in 1 Second (FEV1)
time frame: 8 weeks (2 periods each lasting 4 weeks)
measure: Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test)
time frame: 8 weeks (2 periods each lasting 4 weeks)
arm group label: Lysozyme 90 mg
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: lysozyme 90 mg
description: Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)
arm group label: Lysozyme 90 mg
other name: PRT10T
intervention type: Drug
intervention name: Placebo
description: Lysozyme Matching Placebo three times daily for 4 weeks followed by Lysozyme 90 mg three times daily for 4 weeks (plus usual COPD medication)
arm group label: Placebo
other name: PRT10T
criteria: 
gender: All
minimum age: 20 Years
maximum age: 84 Years
healthy volunteers: No
last name: Kai Shibata
role: Study Director
affiliation: Drug Fostering and Evoluation Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquaters
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Asthma
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Muramidase