<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/NCT01710488</url>
  </required_header>
  <id_info>
    <org_study_id>EudraCT N. 2008-003842-27</org_study_id>
    <nct_id>NCT01710488</nct_id>
  </id_info>
  <brief_title>Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD</brief_title>
  <acronym>FLOR</acronym>
  <official_title>A Randomized, Controlled, Single-blind, Parallel-group Comparison Between Levofloxacin and Prulifloxacin, in Patients With Acute Exacerbation of COPD Unresponsive to Other Antibiotics and Admitted to the Internal Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fadoi Foundation, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fadoi Foundation, Italy</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to determine the percentage of patients with&#xD;
      &quot;therapeutic success&quot; at the end of the cycle of antibiotic therapy (10 days), in the two&#xD;
      treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be&#xD;
      evaluated on the basis of a score determined in relation to the signs-symptoms of acute&#xD;
      exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to examine the effects of the use of fluoroquinolones a class of&#xD;
      antibiotics introduced relatively recently, in a particular population of patients with acute&#xD;
      exacerbation of COPD, previously treated unsuccessfully with other antibiotics, and&#xD;
      hospitalized in Internal Medicine. These patients reflect the reality of patients admitted to&#xD;
      Internal Medicine, they are characterized by a high frequency of advanced age, polypathology,&#xD;
      with multiple treatments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary objective of the study is to determine the percentage of patients with &quot;therapeutic success&quot; at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin).</measure>
    <time_frame>10 days</time_frame>
    <description>The effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of successful treatment to day 7 of treatment</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>rehospitalization for COPD exacerbation during the follow-up</measure>
    <time_frame>one year</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of episodes of Exacerbations</measure>
    <time_frame>one year</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Additional cycles of antibiotic</measure>
    <time_frame>one year</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>survival</measure>
    <time_frame>one year</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">258</enrollment>
  <condition>COPD Exacerbation</condition>
  <arm_group>
    <arm_group_label>Levofloxacin 1 tablet 500 mg once a day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Levofloxacin 1 tablet 500 mg once a day for 7-10 days. It will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prulifloxacin 1 tablet 600 mg once a day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prulifloxacin 1 tablet 600 mg once a day for 7-10 days. It will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levofloxacin 1 tablet 500 mg once a day</intervention_name>
    <description>Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients:&#xD;
Levofloxacin 500 mg (1 tablet) once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food.</description>
    <arm_group_label>Levofloxacin 1 tablet 500 mg once a day</arm_group_label>
    <other_name>LEVOXACIN 500 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prulifloxacin 1 tablet 600 mg once a day</intervention_name>
    <description>Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients:&#xD;
Prulifloxacin 1 tablet 600 mg once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food.</description>
    <arm_group_label>Prulifloxacin 1 tablet 600 mg once a day</arm_group_label>
    <other_name>UNIDROX 600 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Presence of purulent sputum documented by colorimetric assay (Allegra et al., Resp&#xD;
             Med 2005), plus at least two of the following signs-symptoms&#xD;
&#xD;
          -  Increased cough&#xD;
&#xD;
          -  Increased dyspnea&#xD;
&#xD;
          -  Increase in sputum volume appeared at least 3 days&#xD;
&#xD;
          -  previous antibiotic treatment with any medication (eg, amoxicillin, amoxicillin /&#xD;
             clavulanate, cephalosporins or macrolides) with the exception of quinolones, conducted&#xD;
             for at least 3 days with persistence or worsening of symptoms and subsequent use of&#xD;
             hospital&#xD;
&#xD;
          -  ≥ 60 years&#xD;
&#xD;
          -  FEV1 &lt;80% and ≥ 30% and ratio FEV 1 / FVC &lt;70%&#xD;
&#xD;
          -  chest x-ray negative for inflammatory infiltrates&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  asthma&#xD;
&#xD;
          -  pulmonary neoplasms&#xD;
&#xD;
          -  a history of allergy or hypersensitivity to quinolones&#xD;
&#xD;
          -  impracticability in oral antibiotic and / or altered ability to absorption by the&#xD;
             gastrointestinal system&#xD;
&#xD;
          -  a history of epilepsy, seizures, cerebral vascular disease (stroke cerebri within 6&#xD;
             months)&#xD;
&#xD;
          -  history of tendinopathy&#xD;
&#xD;
          -  note or severe renal impairment creatinine&gt; than twice the upper limit of the normal&#xD;
             range or hepatic impairment (AST and / or ALT&gt; twice the upper limit of the normal&#xD;
             range)&#xD;
&#xD;
          -  patients with sepsis, tuberculosis or other infections in other organs or systems&#xD;
&#xD;
          -  cystic fibrosis&#xD;
&#xD;
          -  patients with inherited tolerance to intolerance, Lapp lactase deficiency or&#xD;
             glucose-galactose malabsorption, or deficiency of the enzyme glucose-6-phosphate&#xD;
             dehydrogenase&#xD;
&#xD;
          -  pregnant or breastfeeding&#xD;
&#xD;
          -  drug or alcohol addiction&#xD;
&#xD;
          -  experimental concomitant treatment with other drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gualberto GG Gussoni, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Dept. Clinical Research &quot;Study Centre&quot; - FadoiFoundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospita &quot;San Francesco Caracciolo&quot;</name>
      <address>
        <city>Agnone</city>
        <zip>86081</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Alghero</name>
      <address>
        <city>Alghero</city>
        <zip>07041</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;Cardinal Massaia&quot;</name>
      <address>
        <city>Asti</city>
        <zip>14100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;Fatebenefratelli&quot;</name>
      <address>
        <city>Benevento</city>
        <zip>82100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Bordighera</name>
      <address>
        <city>Bordighera</city>
        <zip>18012</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;San Giovanni di Dio&quot;</name>
      <address>
        <city>Cagliari</city>
        <zip>09124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;Pugliese-Ciaccio&quot;</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;L.Parodi Delfino&quot;</name>
      <address>
        <city>Colleferro</city>
        <zip>00034</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospita &quot;San Giovanni di Dio&quot;</name>
      <address>
        <city>Crotone</city>
        <zip>88900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;E.Profili&quot; of Fabriano</name>
      <address>
        <city>Fabriano</city>
        <zip>60044</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;F. Veneziale&quot;</name>
      <address>
        <city>Isernia</city>
        <zip>86170</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Civile Legnano</name>
      <address>
        <city>Legnano</city>
        <zip>20025</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Ortona</name>
      <address>
        <city>Ortona</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Fatebenefratelli &quot;Buccheri La Ferla&quot;</name>
      <address>
        <city>Palermo</city>
        <zip>90123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;Sant'Anna&quot;</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42035</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot; Santa Maria Nuova&quot;</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;Policlinico Universitario Campus Biomedico&quot;</name>
      <address>
        <city>Rome</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;Casa Sollievo della Sofferenza&quot;</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Scandiano</name>
      <address>
        <city>Scandiano</city>
        <zip>42019</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;Paolo Dettori&quot;</name>
      <address>
        <city>Tempio Pausania</city>
        <zip>0729</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;Santa Maria&quot; of Terni</name>
      <address>
        <city>Terni</city>
        <zip>05100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;San Giovanni Bosco&quot;</name>
      <address>
        <city>Torino</city>
        <zip>10100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;Jazzolino&quot;</name>
      <address>
        <city>Vibo Valentia</city>
        <zip>89900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;San Bortolo&quot;</name>
      <address>
        <city>Vicenza</city>
        <zip>36100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital &quot;Santa Maria Maddalena&quot;</name>
      <address>
        <city>Volterra</city>
        <zip>56048</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD exacerbation</keyword>
  <keyword>fluoroquinolones,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Levofloxacin</mesh_term>
    <mesh_term>Prulifloxacin</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/NCT01710488
org study id: EudraCT N. 2008-003842-27
nct id: NCT01710488
lead sponsor: 
has dmc: Yes
The primary objective of the study is to determine the percentage of patients with
      "therapeutic success" at the end of the cycle of antibiotic therapy (10 days), in the two
      treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be
      evaluated on the basis of a score determined in relation to the signs-symptoms of acute
      exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)
The aim of this study was to examine the effects of the use of fluoroquinolones a class of
      antibiotics introduced relatively recently, in a particular population of patients with acute
      exacerbation of COPD, previously treated unsuccessfully with other antibiotics, and
      hospitalized in Internal Medicine. These patients reflect the reality of patients admitted to
      Internal Medicine, they are characterized by a high frequency of advanced age, polypathology,
      with multiple treatments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: The primary objective of the study is to determine the percentage of patients with "therapeutic success" at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin).
time frame: 10 days
description: The effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)
measure: Percentage of successful treatment to day 7 of treatment
time frame: 7 days
measure: rehospitalization for COPD exacerbation during the follow-up
time frame: one year
measure: Number of episodes of Exacerbations
time frame: one year
measure: Additional cycles of antibiotic
time frame: one year
measure: survival
time frame: one year
arm group label: Levofloxacin 1 tablet 500 mg once a day
arm group type: Active Comparator
description: Levofloxacin 1 tablet 500 mg once a day for 7-10 days. It will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients
arm group label: Prulifloxacin 1 tablet 600 mg once a day
arm group type: Experimental
description: Prulifloxacin 1 tablet 600 mg once a day for 7-10 days. It will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients
intervention type: Drug
intervention name: Levofloxacin 1 tablet 500 mg once a day
description: Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients:
Levofloxacin 500 mg (1 tablet) once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food.
arm group label: Levofloxacin 1 tablet 500 mg once a day
other name: LEVOXACIN 500 mg
intervention type: Drug
intervention name: Prulifloxacin 1 tablet 600 mg once a day
description: Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients:
Prulifloxacin 1 tablet 600 mg once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food.
arm group label: Prulifloxacin 1 tablet 600 mg once a day
other name: UNIDROX 600 mg
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Gualberto GG Gussoni, MD, PhD
role: Study Director
affiliation: Dept. Clinical Research "Study Centre" - FadoiFoundation
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country: Italy
responsible party type: Sponsor
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Levofloxacin
mesh term: Prulifloxacin