<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/NCT02234739</url>
  </required_header>
  <id_info>
    <org_study_id>Hangzhou Red Cross Hospital</org_study_id>
    <nct_id>NCT02234739</nct_id>
  </id_info>
  <brief_title>Voriconazole for IPA in Chinese Patients With COPD</brief_title>
  <acronym>VIA-COPD</acronym>
  <official_title>Efficacy and Safety of Voriconazole for Treatment of Invasive Pulmonary Aspergillosis Secondary to COPD: a Multi-center Prospective，Open Cohort Study (VIA-COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Red Cross Hospital, Hangzhou, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sir Run Run Shaw Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First People's Hospital of Hangzhou</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second People's Hospital of Hangzhou</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Third Affiliated hospital of Zhejiang Chinese Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ningbo People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiaoshan People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiaoshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First People's Hospital of Huzhou</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Red Cross Hospital, Hangzhou, China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      voriconazole is recommended as first-line therapy for invasive pulmonary aspergillosis,&#xD;
      however the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis&#xD;
      secondary to COPD is not clear. This study aims to investigate the effectiveness and&#xD;
      tolerability of intravenous voriconazole for treatment of invasive pulmonary aspergillosis in&#xD;
      Chinese patients with COPD, by monitoring changes in clinical symptoms, eradication of&#xD;
      aspergillus, improvement of chest imaging as well as record of possible adverse reactions&#xD;
      following 2-week intravenous instillation of voriconazole.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multiple-center open-label clinical trial to study the efficacy and safety of&#xD;
      voriconazole for treating invasive pulmonary aspergillosis secondary to COPD in Chinese&#xD;
      patients.The primary endpoint is treatment success rate as defined by improvement of symptoms&#xD;
      related to invasive pulmonary asperillosis, secondary endpoints include the mortality, the&#xD;
      eradication of sputum asperillus and profile of adverse reactions following intravenous&#xD;
      instillation of voriconazole.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>success rate of voriconazole antifungal treatment</measure>
    <time_frame>2-week</time_frame>
    <description>treatment success if defined as improve of symptoms related to invasive pulmonary aspergillosis, such as fever, wheezing, chest pain, dyspnea, and hemoptysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse reactions following voriconazole treatment</measure>
    <time_frame>2-week</time_frame>
    <description>any adverse events including complaints, physical signs, or laboratory abnormalities</description>
  </secondary_outcome>
  <other_outcome>
    <measure>all-cause mortality of invasive pulmonary aspergillosis secondary to COPD</measure>
    <time_frame>2 week</time_frame>
    <description>all-cause mortality</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Invasive Pulmonary Aspergillosis</condition>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>active treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chinese patients with invasive pulmonary aspergillosis treated by voriconazole, who has COPD as underlying condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Voriconazole</intervention_name>
    <description>2-week long intravenous instillation of voriconazole</description>
    <arm_group_label>active treatment</arm_group_label>
    <other_name>Vfend</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cases of invasive pulmonary aspergillosis secondary to COPD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of voriconazole or itraconazole or amphotericin B or caspofungin or micafungin&#xD;
             within 4 weeks prior to enrollment&#xD;
&#xD;
          -  Known allergy to voriconazole&#xD;
&#xD;
          -  Severe impairment of live or kidney function&#xD;
&#xD;
          -  Septic shock&#xD;
&#xD;
          -  Unwilling to sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chuang Cai, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Red Cross Hospital, Hangzhou, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chuang Cai, doctor</last_name>
    <phone>86-0571-56109772</phone>
    <email>tinattm@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhijian Bao, master</last_name>
    <phone>86-0571-56109707</phone>
    <email>baozhijian@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hangzhou Red Cross Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Chuang Cai, doctor</last_name>
      <phone>86-0571-56109772</phone>
      <email>tinattm@163.com</email>
    </contact>
    <investigator>
      <last_name>Enguo Chen, doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Limin Wang, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Qun Nv, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rongzhuan Zhao, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>YongChen Li, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xiaoping Huang, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bin Wang, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>jianping Yan, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>jianpu Xu, bachelor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Tutar N, Metan G, Koc AN, Yilmaz I, Bozkurt I, Simsek ZO, Buyukoglan H, Kanbay A, Oymak FS, Gulmez I, Demir R. Invasive pulmonary aspergillosis in patients with chronic obstructive pulmonary disease. Multidiscip Respir Med. 2013 Sep 4;8(1):59. doi: 10.1186/2049-6958-8-59. eCollection 2013.</citation>
    <PMID>24135224</PMID>
  </reference>
  <reference>
    <citation>Patel DA, Gao X, Stephens JM, Forshag MS, Tarallo M. US hospital database analysis of invasive aspergillosis in the chronic obstructive pulmonary disease non-traditional host. J Med Econ. 2011;14(2):227-37. doi: 10.3111/13696998.2011.564246. Epub 2011 Mar 9.</citation>
    <PMID>21385144</PMID>
  </reference>
  <reference>
    <citation>Ader F, Bienvenu AL, Rammaert B, Nseir S. Management of invasive aspergillosis in patients with COPD: rational use of voriconazole. Int J Chron Obstruct Pulmon Dis. 2009;4:279-87. doi: 10.2147/copd.s4229. Epub 2009 Aug 3.</citation>
    <PMID>19684861</PMID>
  </reference>
  <reference>
    <citation>Walsh TJ, Anaissie EJ, Denning DW, Herbrecht R, Kontoyiannis DP, Marr KA, Morrison VA, Segal BH, Steinbach WJ, Stevens DA, van Burik JA, Wingard JR, Patterson TF; Infectious Diseases Society of America. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2008 Feb 1;46(3):327-60. doi: 10.1086/525258. No abstract available.</citation>
    <PMID>18177225</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Red Cross Hospital, Hangzhou, China</investigator_affiliation>
    <investigator_full_name>caichuang</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>voriconazole</keyword>
  <keyword>COPD</keyword>
  <keyword>invasive pulmonary aspergillosis</keyword>
  <keyword>efficacy</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspergillosis</mesh_term>
    <mesh_term>Pulmonary Aspergillosis</mesh_term>
    <mesh_term>Invasive Pulmonary Aspergillosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Voriconazole</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/NCT02234739
org study id: Hangzhou Red Cross Hospital
nct id: NCT02234739
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
voriconazole is recommended as first-line therapy for invasive pulmonary aspergillosis,
      however the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis
      secondary to COPD is not clear. This study aims to investigate the effectiveness and
      tolerability of intravenous voriconazole for treatment of invasive pulmonary aspergillosis in
      Chinese patients with COPD, by monitoring changes in clinical symptoms, eradication of
      aspergillus, improvement of chest imaging as well as record of possible adverse reactions
      following 2-week intravenous instillation of voriconazole.
This is a multiple-center open-label clinical trial to study the efficacy and safety of
      voriconazole for treating invasive pulmonary aspergillosis secondary to COPD in Chinese
      patients.The primary endpoint is treatment success rate as defined by improvement of symptoms
      related to invasive pulmonary asperillosis, secondary endpoints include the mortality, the
      eradication of sputum asperillus and profile of adverse reactions following intravenous
      instillation of voriconazole.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: success rate of voriconazole antifungal treatment
time frame: 2-week
description: treatment success if defined as improve of symptoms related to invasive pulmonary aspergillosis, such as fever, wheezing, chest pain, dyspnea, and hemoptysis
measure: adverse reactions following voriconazole treatment
time frame: 2-week
description: any adverse events including complaints, physical signs, or laboratory abnormalities
measure: all-cause mortality of invasive pulmonary aspergillosis secondary to COPD
time frame: 2 week
description: all-cause mortality
arm group label: active treatment
arm group type: Experimental
description: Chinese patients with invasive pulmonary aspergillosis treated by voriconazole, who has COPD as underlying condition
intervention type: Drug
intervention name: Voriconazole
description: 2-week long intravenous instillation of voriconazole
arm group label: active treatment
other name: Vfend
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
last name: Chuang Cai, doctor
role: Principal Investigator
affiliation: Red Cross Hospital, Hangzhou, China
last name: Chuang Cai, doctor
phone: 86-0571-56109772
email: tinattm@163.com
last name: Zhijian Bao, master
phone: 86-0571-56109707
email: baozhijian@163.com
facility: 
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
citation: Tutar N, Metan G, Koc AN, Yilmaz I, Bozkurt I, Simsek ZO, Buyukoglan H, Kanbay A, Oymak FS, Gulmez I, Demir R. Invasive pulmonary aspergillosis in patients with chronic obstructive pulmonary disease. Multidiscip Respir Med. 2013 Sep 4;8(1):59. doi: 10.1186/2049-6958-8-59. eCollection 2013.
PMID: 24135224
citation: Patel DA, Gao X, Stephens JM, Forshag MS, Tarallo M. US hospital database analysis of invasive aspergillosis in the chronic obstructive pulmonary disease non-traditional host. J Med Econ. 2011;14(2):227-37. doi: 10.3111/13696998.2011.564246. Epub 2011 Mar 9.
PMID: 21385144
citation: Ader F, Bienvenu AL, Rammaert B, Nseir S. Management of invasive aspergillosis in patients with COPD: rational use of voriconazole. Int J Chron Obstruct Pulmon Dis. 2009;4:279-87. doi: 10.2147/copd.s4229. Epub 2009 Aug 3.
PMID: 19684861
citation: Walsh TJ, Anaissie EJ, Denning DW, Herbrecht R, Kontoyiannis DP, Marr KA, Morrison VA, Segal BH, Steinbach WJ, Stevens DA, van Burik JA, Wingard JR, Patterson TF; Infectious Diseases Society of America. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2008 Feb 1;46(3):327-60. doi: 10.1086/525258. No abstract available.
PMID: 18177225
responsible party type: Principal Investigator
investigator affiliation: Red Cross Hospital, Hangzhou, China
investigator full name: caichuang
investigator title: professor
mesh term: Aspergillosis
mesh term: Pulmonary Aspergillosis
mesh term: Invasive Pulmonary Aspergillosis
mesh term: Voriconazole