<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/NCT02994017</url>
  </required_header>
  <id_info>
    <org_study_id>2011_31</org_study_id>
    <secondary_id>2011-A01532-39</secondary_id>
    <nct_id>NCT02994017</nct_id>
  </id_info>
  <brief_title>Prognostic Value of Functional Exercise Test (EFX) in Cystic Fibrosis</brief_title>
  <acronym>EFX</acronym>
  <official_title>Prognostic Value of Functional Exercise Test (EFX) in Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of study is to prospectively determine if CPET with blood gas analysis should&#xD;
      have a prognostic value in CF. The study plans to include 300 cystic fibrosis patients.&#xD;
      Inclusion criteria will be: age &gt;15 years, cystic fibrosis confirmed by chloride sweat test&#xD;
      or genetic analysis, clinical and functional stability in the 2 month before CPET. Patients&#xD;
      will perform a maximal exercise test on a cycloergometer during the inclusion visit, with&#xD;
      pulmonary function testing and a six-minute walk test. The study will also include a visit&#xD;
      every 6 months with: body mass index calculation, pulmonary function testing with DLCO&#xD;
      (diffusing lung capacity for carbon monoxide), a six minute walk test, and&#xD;
      antibacteriological study of sputum. The results of this study could help identify earlier&#xD;
      the patients for referral to a lung transplantation centre, by using the usual criteria and&#xD;
      the CPET abnormalities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current guidelines for referring cystic fibrosis (CF) patients for lung transplantation,&#xD;
      based on clinical and functional resting parameters, are insufficient to predict 3-year&#xD;
      mortality. Previous studies have shown that sex, impaired pulmonary function, undernutrition&#xD;
      and colonization of the respiratory tract by Pseudomonas aeruginosa are associated with a&#xD;
      poor prognosis. Current guidelines for referral to a lung transplant center include age, sex,&#xD;
      forced expiratory volume at one second (FEV1) below 30% predicted or a rapid decline of FEV1,&#xD;
      in particular in young female patients, increasing frequency of exacerbations requiring&#xD;
      antibiotic therapy, refractory or recurrent pneumothorax, recurrent hemoptysis not controlled&#xD;
      by embolization. But, despite these criteria, near that 30% of patients are still dying while&#xD;
      on the lung transplant waiting list, or are transplanted in high emergency. Cardiopulmonary&#xD;
      exercise testing (CPET) in CF patients would have an interest in the following of cystic&#xD;
      fibrosis patients. A previous study, carried out on fifty one adult patients, showed that&#xD;
      CPET with blood gas analysis may have a prognosis value in cystic fibrosis. The authors found&#xD;
      that a BMI &lt; 19.8 and P(A-a)O2 peak &gt; 43 mmHg were independently associated with a lower&#xD;
      chance of survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2012</start_date>
  <completion_date type="Actual">June 16, 2019</completion_date>
  <primary_completion_date type="Actual">June 16, 2019</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>at five years</time_frame>
    <description>the survival is defined by the occurrence of death or lung transplantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6 minute walking distance</measure>
    <time_frame>Every 12 months during 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body mass index calculation</measure>
    <time_frame>Every 12 months during 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sputum sample culture</measure>
    <time_frame>Every 12 months during 5 years</time_frame>
    <description>(a descriptive analysis of Haemophilus influenzae, Staphylococcus aureus, Pseudomonas aeruginosa,Burkholderia cepacia streptococci in the bacterial flora of sputum)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulmonary function testing with DLCO</measure>
    <time_frame>Every 12 months during 5 years</time_frame>
    <description>diffusing lung capacity for carbon monoxide.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">287</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>cystic fibrosis patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cardiopulmonary exercise testing</intervention_name>
    <description>The Cardiopulmonary exercise testing (CPET) was performed at the beginning of the study, the same at each center. Each patient underwent a symptom-limited incremental exercise test on an ergometric bicycle (Ergoline-Ergometrics 800®). The protocol included a warm-up period of 3 min at 20 W followed by a progressively increasing work rate (WR) in a ramp fashion and then 3 min recovery. The ramped WR increment was individualized (range,8-30 W/min). during exercise, heart rate (HR) was monitored continuously by 12-lead ECG, and arterial oxygen saturation (SpO2) was measured by pulse oximetry (Nellcor N-395). The expired gases were analyzed with an Ergocard®, focusing on oxygen consumption(VO2), carbon dioxide production (VCO2), minute ventilation (VE), and tidal volume (VT).</description>
    <arm_group_label>cystic fibrosis patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age more than 15 years&#xD;
&#xD;
          -  Cystic fibrosis diagnosed by positive sweat chloride test or genetic test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  waiting on transplantation list&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Prevotat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Calmette, CHRU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>February 3, 2023</last_update_submitted>
  <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cystic fibrosis</keyword>
  <keyword>Cardiopulmonary exercise testing</keyword>
  <keyword>prognostic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_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/NCT02994017
org study id: 2011_31
secondary id: 2011-A01532-39
nct id: NCT02994017
lead sponsor: 
has dmc: No
The objective of study is to prospectively determine if CPET with blood gas analysis should
      have a prognostic value in CF. The study plans to include 300 cystic fibrosis patients.
      Inclusion criteria will be: age >15 years, cystic fibrosis confirmed by chloride sweat test
      or genetic analysis, clinical and functional stability in the 2 month before CPET. Patients
      will perform a maximal exercise test on a cycloergometer during the inclusion visit, with
      pulmonary function testing and a six-minute walk test. The study will also include a visit
      every 6 months with: body mass index calculation, pulmonary function testing with DLCO
      (diffusing lung capacity for carbon monoxide), a six minute walk test, and
      antibacteriological study of sputum. The results of this study could help identify earlier
      the patients for referral to a lung transplantation centre, by using the usual criteria and
      the CPET abnormalities.
Current guidelines for referring cystic fibrosis (CF) patients for lung transplantation,
      based on clinical and functional resting parameters, are insufficient to predict 3-year
      mortality. Previous studies have shown that sex, impaired pulmonary function, undernutrition
      and colonization of the respiratory tract by Pseudomonas aeruginosa are associated with a
      poor prognosis. Current guidelines for referral to a lung transplant center include age, sex,
      forced expiratory volume at one second (FEV1) below 30% predicted or a rapid decline of FEV1,
      in particular in young female patients, increasing frequency of exacerbations requiring
      antibiotic therapy, refractory or recurrent pneumothorax, recurrent hemoptysis not controlled
      by embolization. But, despite these criteria, near that 30% of patients are still dying while
      on the lung transplant waiting list, or are transplanted in high emergency. Cardiopulmonary
      exercise testing (CPET) in CF patients would have an interest in the following of cystic
      fibrosis patients. A previous study, carried out on fifty one adult patients, showed that
      CPET with blood gas analysis may have a prognosis value in cystic fibrosis. The authors found
      that a BMI < 19.8 and P(A-a)O2 peak > 43 mmHg were independently associated with a lower
      chance of survival.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Survival
time frame: at five years
description: the survival is defined by the occurrence of death or lung transplantation.
measure: 6 minute walking distance
time frame: Every 12 months during 5 years
measure: body mass index calculation
time frame: Every 12 months during 5 years
measure: sputum sample culture
time frame: Every 12 months during 5 years
description: (a descriptive analysis of Haemophilus influenzae, Staphylococcus aureus, Pseudomonas aeruginosa,Burkholderia cepacia streptococci in the bacterial flora of sputum)
measure: pulmonary function testing with DLCO
time frame: Every 12 months during 5 years
description: diffusing lung capacity for carbon monoxide.
arm group label: cystic fibrosis patients
arm group type: Other
intervention type: Other
intervention name: cardiopulmonary exercise testing
description: The Cardiopulmonary exercise testing (CPET) was performed at the beginning of the study, the same at each center. Each patient underwent a symptom-limited incremental exercise test on an ergometric bicycle (Ergoline-Ergometrics 800®). The protocol included a warm-up period of 3 min at 20 W followed by a progressively increasing work rate (WR) in a ramp fashion and then 3 min recovery. The ramped WR increment was individualized (range,8-30 W/min). during exercise, heart rate (HR) was monitored continuously by 12-lead ECG, and arterial oxygen saturation (SpO2) was measured by pulse oximetry (Nellcor N-395). The expired gases were analyzed with an Ergocard®, focusing on oxygen consumption(VO2), carbon dioxide production (VCO2), minute ventilation (VE), and tidal volume (VT).
arm group label: cystic fibrosis patients
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Anne Prevotat, MD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: No