<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/NCT02205255</url>
  </required_header>
  <id_info>
    <org_study_id>s55829 - FarmEc Substudy</org_study_id>
    <nct_id>NCT02205255</nct_id>
  </id_info>
  <brief_title>BACE Trial Substudy 2 - FarmEc Substudy</brief_title>
  <acronym>FarmEc</acronym>
  <official_title>BACE Trial - The Pharmaco-economic Impact of the Azithromycin Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wim Janssens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A second sub-analysis of the BACE trial will include a detailed cost-effectiveness study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our multicenter randomized trial executed in one country will provide an excellent tool for&#xD;
      more precise health economic assessments. In a first approach, rough estimates on savings of&#xD;
      direct costs in the entire study cohort will be made by taking into account the Flemish&#xD;
      average costs for a single hospitalization day at a respiratory ward, for a day at intensive&#xD;
      care, for an emergency visit, for a home physician contact and for an antibiotic-steroid&#xD;
      course. A more detailed cost-effectiveness and cost-utility analysis at 3 and 9 months&#xD;
      interval will only be performed in case significant clinical benefits are found in favor of&#xD;
      the active treatment.&#xD;
&#xD;
      For this purpose medical resource use data will be collected retrospectively via hospital&#xD;
      invoices (direct costs including drugs, physician visits, laboratory tests, technical exams,&#xD;
      medical imaging, hospital stay) but also prospectively via patient diaries, to cover direct&#xD;
      and indirect costs during the entire outpatient period, and will be linked to EQ5D scores.&#xD;
&#xD;
      Patient will have to give informed consent that additional to the clinical evaluation,&#xD;
      invoices will be collected. However, individual patients can still opt out for these analyses&#xD;
      (sub-study) and only participate in the medical intervention study (main study).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2014</start_date>
  <completion_date type="Actual">April 2020</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total cost (direct and Indirect cost) during the entire study participation</measure>
    <time_frame>At 3 month interval</time_frame>
    <description>Direct costs (including drugs, physician visits, laboratory tests, technical exams, medical imaging, hospital stay) will be assessed by collecting the medical resource use data retrospectively via hospital invoices and prospectively via patient diaries.&#xD;
Indirect costs (relating to time, convenience, and transportation) will be assessed by collecting the medical resource use data prospectively via patient diaries.&#xD;
This outcome measure will also be analysed in following subgroups:&#xD;
Male vs female&#xD;
Smoker vs ex-smoker (stopped smoking &gt; 6 months)&#xD;
GOLD A, B vs GOLD C vs GOLD D&#xD;
Former GOLD I, II vs III vs IV&#xD;
High CRP (&gt; 50 mg/dL) vs low CRP (&lt; 50 mg/dL)&#xD;
Age &lt; 60 years vs age 60 - 70 years vs age &gt; 70 years&#xD;
Anthonissen I vs Anthonissen II vs Anthonissen III at admission&#xD;
ICS use vs no ICS use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total cost (direct and Indirect cost) during the entire study participation</measure>
    <time_frame>At 9 month interval</time_frame>
    <description>Direct costs (including drugs, physician visits, laboratory tests, technical exams, medical imaging, hospital stay) will be assessed by collecting the medical resource use data retrospectively via hospital invoices and prospectively via patient diaries.&#xD;
Indirect costs (relating to time, convenience, and transportation) will be assessed by collecting the medical resource use data prospectively via patient diaries.&#xD;
This outcome measure will also be analysed in following subgroups:&#xD;
Male vs female&#xD;
Smoker vs ex-smoker (stopped smoking &gt; 6 months)&#xD;
GOLD A, B vs GOLD C vs GOLD D&#xD;
Former GOLD I, II vs III vs IV&#xD;
High CRP (&gt; 50 mg/dL) vs low CRP (&lt; 50 mg/dL)&#xD;
Age &lt; 60 years vs age 60 - 70 years vs age &gt; 70 years&#xD;
Anthonissen I vs Anthonissen II vs Anthonissen III at admission&#xD;
ICS use vs no ICS use</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Azithromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N = 250 From day 1 up to and including day 3: 500 mg azithromycin PO once a day From day 4 up to and including day 90: 250 mg azithromycin PO once every 2 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>N = 250 From day 1 up to and including day 3: 500 mg placebo PO once a day From day 4 up to and including day 90: 250 mg placebo PO once every 2 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <description>From day 1 up to and including day 3: 500 mg azithromycin or placebo PO once a day From day 4 up to and including day 90: 250 mg azithromycin or placebo PO once every 2 days</description>
    <arm_group_label>Azithromycin</arm_group_label>
    <other_name>Azitromcyine CF</other_name>
    <other_name>ATC code: J01FA10</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Inactive substance</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Established diagnosis of COPD by medical doctor (based on clinical history OR&#xD;
             pulmonary function test)&#xD;
&#xD;
          -  Smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes&#xD;
             a day for 10 years, or 10 cigarettes a day for 20 years, etc.)&#xD;
&#xD;
          -  Current hospitalization for potential infectious AECOPD treated with standard therapy&#xD;
&#xD;
          -  History of at least one exacerbation during the last year (prior to the current&#xD;
             hospital admission) for which systemic steroids and/or antibiotics were taken&#xD;
&#xD;
          -  ECG at admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mechanical or non-invasive ventilation at moment of randomization (D1)&#xD;
&#xD;
          -  Long QT interval on ECG (QTc &gt; 450msec for males or &gt; 470msec for females)&#xD;
&#xD;
          -  History of life-threatening arrhythmias&#xD;
&#xD;
          -  Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before start of study drug&#xD;
&#xD;
          -  Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission&#xD;
&#xD;
          -  Drugs with high risk for long QT interval and torsade de pointes (amiodarone,&#xD;
             flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides)&#xD;
&#xD;
          -  Documented uncorrected severe hypokalemia (K+ &lt; 3.0 mmol/L) or hypomagnesemia (Mg2+ &lt;&#xD;
             0.5 mmol/L)&#xD;
&#xD;
          -  Chronic systemic steroids (&gt; 4 mg methylprednisolone /day for ≥ 2 months)&#xD;
&#xD;
          -  Actual use of macrolides for at least 2 weeks&#xD;
&#xD;
          -  Allergy to macrolides&#xD;
&#xD;
          -  Active cancer treatment&#xD;
&#xD;
          -  Life expectancy &lt; 3 months&#xD;
&#xD;
          -  Pregnant or breast-feeding subjects. Woman of childbearing potential must have a&#xD;
             pregnancy test performed and a negative result must be documented before start of&#xD;
             treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wim Janssens, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussel</city>
        <state>Brussel Hoofdstedelijk Gewest</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Pieterziekenhuis</name>
      <address>
        <city>Brussel</city>
        <state>Brussels Hoofdstedelijk Gewest</state>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNA Middelheim</name>
      <address>
        <city>Antwerpen</city>
        <state>Vlaanderen</state>
        <zip>2020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Augustinus Ziekenhuis</name>
      <address>
        <city>Antwerpen</city>
        <state>Vlaanderen</state>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imelda Ziekenhuis</name>
      <address>
        <city>Bonheiden</city>
        <state>Vlaanderen</state>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Jan Brugge Ziekenhuis</name>
      <address>
        <city>Brugge</city>
        <state>Vlaanderen</state>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maria Middelaresziekenhuis</name>
      <address>
        <city>Gent</city>
        <state>Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <state>Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Ziekenhuis</name>
      <address>
        <city>Hasselt</city>
        <state>Vlaanderen</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge Ziekenhuis</name>
      <address>
        <city>Kortrijk</city>
        <state>Vlaanderen</state>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <state>Vlaanderen</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heilig Hart Ziekenhuis</name>
      <address>
        <city>Roeselare</city>
        <state>Vlaanderen</state>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Andriesziekenhuis</name>
      <address>
        <city>Tielt</city>
        <state>Vlaanderen</state>
        <zip>8700</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Charleroi</name>
      <address>
        <city>Charleroi</city>
        <state>Wallonië</state>
        <zip>6110</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Hôpital de Charleroi</name>
      <address>
        <city>Gilly</city>
        <state>Wallonië</state>
        <zip>6060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Liège</name>
      <address>
        <city>Liège</city>
        <state>Wallonië</state>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Mont-Godinne</name>
      <address>
        <city>Yvoir</city>
        <state>Wallonië</state>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze-Lieve-Vrouwziekenhuis</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Reine Astrid</name>
      <address>
        <city>Malmedy</city>
        <zip>4960</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Sainte-Elisabeth</name>
      <address>
        <city>Namur</city>
        <zip>5000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>April 7, 2020</last_update_submitted>
  <last_update_submitted_qc>April 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Wim Janssens</investigator_full_name>
    <investigator_title>MD. PhD</investigator_title>
  </responsible_party>
  <keyword>AECOPD</keyword>
  <keyword>Chronic Obstructive Pulmonary Disease</keyword>
  <keyword>Acute exacerbation</keyword>
  <keyword>Hospitalization</keyword>
  <keyword>Azithromycin</keyword>
  <keyword>Macrolides</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <keyword>Placebo</keyword>
  <keyword>Economic Impact</keyword>
  <keyword>Cost-effectiveness</keyword>
  <keyword>EQ5D</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>Azithromycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02205255
org study id: s55829 - FarmEc Substudy
nct id: NCT02205255
lead sponsor: 
has dmc: No
A second sub-analysis of the BACE trial will include a detailed cost-effectiveness study.
Our multicenter randomized trial executed in one country will provide an excellent tool for
      more precise health economic assessments. In a first approach, rough estimates on savings of
      direct costs in the entire study cohort will be made by taking into account the Flemish
      average costs for a single hospitalization day at a respiratory ward, for a day at intensive
      care, for an emergency visit, for a home physician contact and for an antibiotic-steroid
      course. A more detailed cost-effectiveness and cost-utility analysis at 3 and 9 months
      interval will only be performed in case significant clinical benefits are found in favor of
      the active treatment.

      For this purpose medical resource use data will be collected retrospectively via hospital
      invoices (direct costs including drugs, physician visits, laboratory tests, technical exams,
      medical imaging, hospital stay) but also prospectively via patient diaries, to cover direct
      and indirect costs during the entire outpatient period, and will be linked to EQ5D scores.

      Patient will have to give informed consent that additional to the clinical evaluation,
      invoices will be collected. However, individual patients can still opt out for these analyses
      (sub-study) and only participate in the medical intervention study (main study).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Total cost (direct and Indirect cost) during the entire study participation
time frame: At 3 month interval
description: Direct costs (including drugs, physician visits, laboratory tests, technical exams, medical imaging, hospital stay) will be assessed by collecting the medical resource use data retrospectively via hospital invoices and prospectively via patient diaries.
Indirect costs (relating to time, convenience, and transportation) will be assessed by collecting the medical resource use data prospectively via patient diaries.
This outcome measure will also be analysed in following subgroups:
Male vs female
Smoker vs ex-smoker (stopped smoking > 6 months)
GOLD A, B vs GOLD C vs GOLD D
Former GOLD I, II vs III vs IV
High CRP (> 50 mg/dL) vs low CRP (< 50 mg/dL)
Age < 60 years vs age 60 - 70 years vs age > 70 years
Anthonissen I vs Anthonissen II vs Anthonissen III at admission
ICS use vs no ICS use
measure: Total cost (direct and Indirect cost) during the entire study participation
time frame: At 9 month interval
description: Direct costs (including drugs, physician visits, laboratory tests, technical exams, medical imaging, hospital stay) will be assessed by collecting the medical resource use data retrospectively via hospital invoices and prospectively via patient diaries.
Indirect costs (relating to time, convenience, and transportation) will be assessed by collecting the medical resource use data prospectively via patient diaries.
This outcome measure will also be analysed in following subgroups:
Male vs female
Smoker vs ex-smoker (stopped smoking > 6 months)
GOLD A, B vs GOLD C vs GOLD D
Former GOLD I, II vs III vs IV
High CRP (> 50 mg/dL) vs low CRP (< 50 mg/dL)
Age < 60 years vs age 60 - 70 years vs age > 70 years
Anthonissen I vs Anthonissen II vs Anthonissen III at admission
ICS use vs no ICS use
arm group label: Azithromycin
arm group type: Experimental
description: N = 250 From day 1 up to and including day 3: 500 mg azithromycin PO once a day From day 4 up to and including day 90: 250 mg azithromycin PO once every 2 days
arm group label: Placebo
arm group type: Placebo Comparator
description: N = 250 From day 1 up to and including day 3: 500 mg placebo PO once a day From day 4 up to and including day 90: 250 mg placebo PO once every 2 days
intervention type: Drug
intervention name: Azithromycin
description: From day 1 up to and including day 3: 500 mg azithromycin or placebo PO once a day From day 4 up to and including day 90: 250 mg azithromycin or placebo PO once every 2 days
arm group label: Azithromycin
other name: Azitromcyine CF
other name: ATC code: J01FA10
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
other name: Inactive substance
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wim Janssens, MD PhD
role: Principal Investigator
affiliation: KU Leuven
facility: 
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country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: KU Leuven
investigator full name: Wim Janssens
investigator title: MD. PhD
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Azithromycin
sharing ipd: No