<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/NCT02189577</url>
  </required_header>
  <id_info>
    <org_study_id>CCD-05993AA1-09</org_study_id>
    <secondary_id>2013-005268-25</secondary_id>
    <nct_id>NCT02189577</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients</brief_title>
  <acronym>Trigon</acronym>
  <official_title>A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease</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 purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate&#xD;
      bromide) for the treatment of COPD patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover&#xD;
      Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI&#xD;
      (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Change from baseline in pre-dose morning FEV1 on Day 28</measure>
    <time_frame>Day 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to day 28 in area under the curve for forced expiratory volume in 1 second measured at 11 timepoints between 0 to 12 hours postdose (FEV1 AUC0-12h)</measure>
    <time_frame>Day 28</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>CHF 5259</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CHF 5259</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>CHF 5259</intervention_name>
    <description>Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.</description>
    <arm_group_label>CHF 5259</arm_group_label>
    <other_name>glycopyrrolate bromide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female adults (40 ≤ age ≤ 80 years) with a diagnosis of COPD&#xD;
&#xD;
          -  Current smokers or ex-smokers&#xD;
&#xD;
          -  A post-bronchodilator FEV1 &lt; 60% of the predicted normal value and a&#xD;
             post-bronchodilator FEV1/FVC &lt; 0.7&#xD;
&#xD;
          -  Positive response to the reversibility test at screening defined as change in FEV1 ≥&#xD;
             5%.&#xD;
&#xD;
          -  BDI score ≤ 10&#xD;
&#xD;
          -  Patients free of exacerbations for at least 1 month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Diagnosis of asthma&#xD;
&#xD;
          -  Patients treated for exacerbations in the 4 weeks prior to screening visit&#xD;
&#xD;
          -  Patients treated with long-acting antihistamines unless taken at stable regimen at&#xD;
             least 2 months prior to screening and to be maintained constant during the study or if&#xD;
             taken as PRN&#xD;
&#xD;
          -  Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic&#xD;
             hypoxemia&#xD;
&#xD;
          -  Known respiratory disorders other than COPD&#xD;
&#xD;
          -  Patients who have clinically significant cardiovascular condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael POLKEY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus, London SW7 2AZ; UK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 1017</name>
      <address>
        <city>Sevlievo</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 1010</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 1011</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 1014</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 1015</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 1016</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 1012</name>
      <address>
        <city>Stara Zagora</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 1013</name>
      <address>
        <city>Troyan</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 2024</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 2028</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 2020 - Pulmonary Research Institute at Hospital Grosshansdorf</name>
      <address>
        <city>Großhansdorf</city>
        <zip>D-22927</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 2027</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 2026</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 2023</name>
      <address>
        <city>Magdeburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 2021</name>
      <address>
        <city>Radebeul</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 2022</name>
      <address>
        <city>Witten</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 3039</name>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 3032</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 3035</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 3037</name>
      <address>
        <city>Lubin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 3031</name>
      <address>
        <city>Ostrowiec Świętokrzyski</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 3033</name>
      <address>
        <city>Oświęcim</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 3038</name>
      <address>
        <city>Rzeszów</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 3034</name>
      <address>
        <city>Tarnów</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 3030</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 3036</name>
      <address>
        <city>Zgierz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus</name>
      <address>
        <city>London</city>
        <zip>SW7 2AZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 4042</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiesi Clinical Trial Site 4041</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Germany</country>
    <country>Poland</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-005268-25</url>
    <description>Study Record on EU Clinical Trials Register including results</description>
  </link>
  <link>
    <url>https://www.chiesi.com/clinic/CSR_Synopsis_CCD-05993AA1-09.pdf</url>
    <description>CSR Synopsis available in the CHIESI Clinical Study Register</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>October 28, 2021</last_update_submitted>
  <last_update_submitted_qc>October 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Obstructive Pulmonary disease</keyword>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Glycopyrrolate</mesh_term>
    <mesh_term>Bromides</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.&#xD;
Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.</ipd_description>
    <ipd_access_criteria>Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.</ipd_access_criteria>
    <ipd_url>https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/</ipd_url>
  </patient_data>
  <!-- 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/NCT02189577
org study id: CCD-05993AA1-09
secondary id: 2013-005268-25
nct id: NCT02189577
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate
      bromide) for the treatment of COPD patients.
A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover
      Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI
      (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in pre-dose morning FEV1 on Day 28
time frame: Day 28
measure: Change from baseline to day 28 in area under the curve for forced expiratory volume in 1 second measured at 11 timepoints between 0 to 12 hours postdose (FEV1 AUC0-12h)
time frame: Day 28
arm group label: CHF 5259
arm group type: Experimental
description: CHF 5259
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: CHF 5259
description: Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
arm group label: CHF 5259
other name: glycopyrrolate bromide
intervention type: Drug
intervention name: Placebo
description: Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Michael POLKEY, MD
role: Principal Investigator
affiliation: Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus, London SW7 2AZ; UK
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country: Bulgaria
country: Germany
country: Poland
country: United Kingdom
url: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-005268-25
description: Study Record on EU Clinical Trials Register including results
url: https://www.chiesi.com/clinic/CSR_Synopsis_CCD-05993AA1-09.pdf
description: CSR Synopsis available in the CHIESI Clinical Study Register
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Glycopyrrolate
mesh term: Bromides
sharing ipd: Yes
ipd description: Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.
Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
ipd access criteria: Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
ipd url: https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/