<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/NCT01689571</url>
  </required_header>
  <id_info>
    <org_study_id>CCD-1202-PR-0080</org_study_id>
    <secondary_id>2012-001483-29</secondary_id>
    <nct_id>NCT01689571</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Inhaled CHF6001 DPI in Asthmatics</brief_title>
  <acronym>CHF6001_POC2</acronym>
  <official_title>A Randomised, Double-blind, Placebo-controlled, Three-way Crossover Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Two Doses of Inhaled CHF6001 DPI After 9 Days of Treatment in Adult Patients With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiesi Farmaceutici S.p.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chiesi Farmaceutici S.p.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to look at the safety, tolerability and efficacy of 2 different doses&#xD;
      of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once a&#xD;
      day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF 6001&#xD;
      after an allergen challenge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Allergen challenge</measure>
    <time_frame>after 9 days of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Induced Sputum</measure>
    <time_frame>After 9 days of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Methacholine challenge</measure>
    <time_frame>After 9 days of treatment</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Pharmacokinetics of CHF6001 and its metabolites</measure>
    <time_frame>after 9 days of treatment</time_frame>
    <description>The following parameters will be evaluated at the steady state: AUC0-t, AUC0-24h, Cmax, Cmin, Cav, tmax, tmin, t½, CL/F and Vz/F</description>
  </other_outcome>
  <other_outcome>
    <measure>Vital signs</measure>
    <time_frame>After single dose and 9 days of treatment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>ECG</measure>
    <time_frame>After single dose and 9 days of treatment</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Placebo DPI</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo by inhalation for 9 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHF6001 DPI Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CHF6001 by inhalation for 9 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHF6001 DPI Dose1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CHF6001 by inhalation for 9 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CHF6001</intervention_name>
    <arm_group_label>CHF6001 DPI Dose 2</arm_group_label>
    <arm_group_label>CHF6001 DPI Dose1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo DPI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written informed consent obtained&#xD;
&#xD;
          -  Non smoking or ex-smokers from at least 1 year prior to study entry&#xD;
&#xD;
          -  Males of females between 18 and 60 years inclusive&#xD;
&#xD;
          -  Body Mass Index between 18 and 32 kg/m2&#xD;
&#xD;
          -  Ability to be trained about the proper use of the inhalation device and to perform&#xD;
             spirometry&#xD;
&#xD;
          -  With mild to moderate allergic asthma as defined by the GINA guideline, steroid naive&#xD;
&#xD;
          -  Atopy to at least one common aeroallergen&#xD;
&#xD;
          -  Positive allergen-induced Early Asthmatic Response and Late Asthmatic Response at&#xD;
             screening&#xD;
&#xD;
          -  Ability to produce an adequate sputum sample&#xD;
&#xD;
          -  Post-menopausal women, women of not childbearing potential or males and females of&#xD;
             childbearing potential willing (they or their partner) to use a reliable method of&#xD;
             contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Worsening of asthma or respiratory tract infection prior to study entry&#xD;
&#xD;
          -  History of life-threatening asthma or hospitalization for asthma prior to the study&#xD;
             entry&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  History of clinically significant hypotensive episodes or fainting, dizziness or&#xD;
             light-headedness&#xD;
&#xD;
          -  History or symptoms of clinically relevant neurologic disease&#xD;
&#xD;
          -  Symptomatic hay fever&#xD;
&#xD;
          -  Unstable concurrent disease that may impact the feasibility of the study&#xD;
&#xD;
          -  Use of systemic corticosteroids, nebulised bronchodilator or oral beta2-agonist&#xD;
&#xD;
          -  Use of leukotrienes modifiers, roflumilast or cromoglycate&#xD;
&#xD;
          -  Use of long acting beta2-agonist or inhaled corticosteroids&#xD;
&#xD;
          -  Use of short-acting or long-acting non-sedatives antihistamines&#xD;
&#xD;
          -  Use of any other medication for the treatment of allergic asthma other than salbutamol&#xD;
&#xD;
          -  Having received an investigational medicinal drug within 30 days prior to study entry&#xD;
&#xD;
          -  Blood drawn of at least 250 ml in the previous 45 days&#xD;
&#xD;
          -  Ongoing use of tobacco&#xD;
&#xD;
          -  Other lung disease&#xD;
&#xD;
          -  Recent history of alcohol dependency&#xD;
&#xD;
          -  Inability to comply with the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dave Singh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medicines Evaluation Unit</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brian Leaker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Respiratory Clinical Trials</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth Tranter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hammersmith Medicines Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hammersmith Medicines Research</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Respiratory Clinical Trials</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicines Evaluation Unit</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-001483-29</url>
    <description>Study Record on EU Clinical Trials Register including results</description>
  </link>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>March 28, 2017</last_update_submitted>
  <last_update_submitted_qc>March 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PDE4 inhibitor</keyword>
  <keyword>Allergen Challenge</keyword>
  <keyword>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/NCT01689571
org study id: CCD-1202-PR-0080
secondary id: 2012-001483-29
nct id: NCT01689571
lead sponsor: 
has dmc: No
The study is designed to look at the safety, tolerability and efficacy of 2 different doses
      of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once a
      day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF 6001
      after an allergen challenge.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Allergen challenge
time frame: after 9 days of treatment
measure: Induced Sputum
time frame: After 9 days of treatment
measure: Methacholine challenge
time frame: After 9 days of treatment
measure: Pharmacokinetics of CHF6001 and its metabolites
time frame: after 9 days of treatment
description: The following parameters will be evaluated at the steady state: AUC0-t, AUC0-24h, Cmax, Cmin, Cav, tmax, tmin, t½, CL/F and Vz/F
measure: Vital signs
time frame: After single dose and 9 days of treatment
measure: ECG
time frame: After single dose and 9 days of treatment
arm group label: Placebo DPI
arm group type: Placebo Comparator
description: Placebo by inhalation for 9 days
arm group label: CHF6001 DPI Dose 2
arm group type: Experimental
description: CHF6001 by inhalation for 9 days
arm group label: CHF6001 DPI Dose1
arm group type: Experimental
description: CHF6001 by inhalation for 9 days
intervention type: Drug
intervention name: CHF6001
arm group label: CHF6001 DPI Dose 2
arm group label: CHF6001 DPI Dose1
intervention type: Drug
intervention name: Placebo
arm group label: Placebo DPI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Dave Singh, MD
role: Principal Investigator
affiliation: Medicines Evaluation Unit
last name: Brian Leaker, MD
role: Principal Investigator
affiliation: Respiratory Clinical Trials
last name: Elizabeth Tranter, MD
role: Principal Investigator
affiliation: Hammersmith Medicines Research
facility: 
facility: 
facility: 
country: United Kingdom
url: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-001483-29
description: Study Record on EU Clinical Trials Register including results
responsible party type: Sponsor
mesh term: Asthma