<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/NCT01730404</url>
  </required_header>
  <id_info>
    <org_study_id>CCD-1201-PR-0079</org_study_id>
    <nct_id>NCT01730404</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients</brief_title>
  <official_title>A Randomised, Double-blind, Double-dummy, Placebo and Active-controlled, Three-way Crossover Study to Evaluate the Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI (1200 µg Daily) in Subjects With COPD</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>
      Phase IIa study in COPD patients aimed to evaluate the safety, tolerability ,pharmacodynamics&#xD;
      (effect on biological markers of inflammation in induced sputum and in blood, and on&#xD;
      pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor) after 28-days of&#xD;
      daily inhaled dosing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 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>Adverse events, adverse drug reactions, serious adverse.</measure>
    <time_frame>After 28 days of treatment</time_frame>
    <description>The number and percentage of subjects experiencing AEs, ADRs, serious AEs and AEs leading to study withdrawal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vital signs</measure>
    <time_frame>After 28 days of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>12-lead ECG parameters</measure>
    <time_frame>After 28 days of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of CHF 6001 and its metabolites</measure>
    <time_frame>After 28 days of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Induction of sputum</measure>
    <time_frame>After 28 days of treatment</time_frame>
    <description>Biomarkers of inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Dyspnea Index and Transition Dyspnea Index Questionnaire</measure>
    <time_frame>After 28 days of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function measurements</measure>
    <time_frame>After 28 days of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>CHF6001</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CHF6001 DPI (Dry Powder Inhaler) once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Roflumilast</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Roflumilast, tablet, once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CHF6001 DPI</intervention_name>
    <arm_group_label>CHF6001</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Roflumilast</intervention_name>
    <arm_group_label>Roflumilast</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent obtained prior to any study-related procedures.&#xD;
&#xD;
          2. Male or female aged between 40 and 70 years inclusive.&#xD;
&#xD;
          3. Current or past smoker of at least 10 pack/years&#xD;
&#xD;
          4. BMI in the range of 18-35 Kg/m2&#xD;
&#xD;
          5. GOLD Stage 2 and 3 COPD subjects&#xD;
&#xD;
          6. A history of chronic bronchitis defined as chronic cough and sputum production&#xD;
&#xD;
          7. At screening, subjects must be able to produce an adequate induced sputum sample&#xD;
&#xD;
          8. Female subjects: post-menopausal women having at least 12 months of natural&#xD;
             (spontaneous) amenorrhea, or women of childbearing potential using two acceptable&#xD;
             methods of contraception for the duration of the study and for the following three&#xD;
             months&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Female subjects: pregnant or lactating women&#xD;
&#xD;
          2. Past or current history of asthma&#xD;
&#xD;
          3. History of clinically significant hypotensive episodes&#xD;
&#xD;
          4. History or symptoms of significant cardiovascular disease&#xD;
&#xD;
          5. History or symptoms of significant neurological disease&#xD;
&#xD;
          6. Unstable concurrent disease&#xD;
&#xD;
          7. An abnormal and clinically significant 12-lead ECG&#xD;
&#xD;
          8. Clinically relevant abnormal laboratory values&#xD;
&#xD;
          9. Use of oral or systemic corticosteroids oral and/or nebulised Beta2 agonists and/or&#xD;
             antibiotics within 6 weeks preceding the screening visit&#xD;
&#xD;
         10. Moderate or severe hepatic impairment (Child-Pugh B or C)&#xD;
&#xD;
         11. Intolerance/hypersensitivity or any contraindication to treatment with roflumilast,&#xD;
             tiotropium bromide or salbutamol or any of the excipients contained in the&#xD;
             formulations used in the study&#xD;
&#xD;
         12. Chronic use of any other medication for treatment of lung disease like xanthines,&#xD;
             antileukotrienes, systemic and inhaled corticosteroids, long acting beta2- agonists,&#xD;
             roflumilast (other than the study drug) and cromoglycates&#xD;
&#xD;
         13. Long term (at least 12 hours daily) use of oxygen therapy for chronic hypoxemia.&#xD;
&#xD;
         14. Having received an investigational medicinal drug within 30 days prior to study entry&#xD;
&#xD;
         15. Blood draws of 250 mL or more within 45 days prior to enrolment into the study.&#xD;
&#xD;
         16. Known respiratory disorders other than COPD.&#xD;
&#xD;
         17. History of alcohol dependency, or substance abuse&#xD;
&#xD;
         18. Inability to comply with the study Protocol for any other reason.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 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 Ltd</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anthony DeSoyza, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Freeman Health System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen Smith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Celerion</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tim Harrison, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nottingham University Hospitals NHS Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Muna Albayaty, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Parexel, early phases</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Belfast</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parexel, early phases</name>
      <address>
        <city>Harrow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicines Evaluation Unit Ltd</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Freeman Hospital</name>
      <address>
        <city>Newcastle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-001005-25</url>
    <description>Study Record on EU Clinical Trials Register including results</description>
  </link>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 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 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01730404
org study id: CCD-1201-PR-0079
nct id: NCT01730404
lead sponsor: 
has dmc: No
Phase IIa study in COPD patients aimed to evaluate the safety, tolerability ,pharmacodynamics
      (effect on biological markers of inflammation in induced sputum and in blood, and on
      pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor) after 28-days of
      daily inhaled dosing.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse events, adverse drug reactions, serious adverse.
time frame: After 28 days of treatment
description: The number and percentage of subjects experiencing AEs, ADRs, serious AEs and AEs leading to study withdrawal.
measure: Vital signs
time frame: After 28 days of treatment
measure: 12-lead ECG parameters
time frame: After 28 days of treatment
measure: Pharmacokinetics of CHF 6001 and its metabolites
time frame: After 28 days of treatment
measure: Induction of sputum
time frame: After 28 days of treatment
description: Biomarkers of inflammation
measure: Baseline Dyspnea Index and Transition Dyspnea Index Questionnaire
time frame: After 28 days of treatment
measure: Lung function measurements
time frame: After 28 days of treatment
arm group label: CHF6001
arm group type: Experimental
description: CHF6001 DPI (Dry Powder Inhaler) once daily
arm group label: Roflumilast
arm group type: Active Comparator
description: Roflumilast, tablet, once daily
arm group label: placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: CHF6001 DPI
arm group label: CHF6001
intervention type: Drug
intervention name: Roflumilast
arm group label: Roflumilast
intervention type: Drug
intervention name: Placebo
arm group label: placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Dave Singh, MD
role: Principal Investigator
affiliation: Medicines Evaluation Unit Ltd
last name: Anthony DeSoyza, MD
role: Principal Investigator
affiliation: Freeman Health System
last name: Stephen Smith, MD
role: Principal Investigator
affiliation: Celerion
last name: Tim Harrison, MD
role: Principal Investigator
affiliation: Nottingham University Hospitals NHS Trust
last name: Muna Albayaty, MD
role: Principal Investigator
affiliation: Parexel, early phases
facility: 
facility: 
facility: 
facility: 
facility: 
country: Ireland
country: United Kingdom
url: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-001005-25
description: Study Record on EU Clinical Trials Register including results
responsible party type: Sponsor