<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/NCT02261350</url>
  </required_header>
  <id_info>
    <org_study_id>2013LF004H</org_study_id>
    <nct_id>NCT02261350</nct_id>
  </id_info>
  <brief_title>Post-hospitalisation Nutritional Support and Gait Speed in COPD</brief_title>
  <official_title>The Effect of Nutritional Support on Gait Speed Following Hospitalisation for Acute Exacerbation of COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Brompton &amp; Harefield NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Hillingdon Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Brompton &amp; Harefield NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the feasibility of delivering different community nutritional interventions to&#xD;
      chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of&#xD;
      malnutrition following a hospitalisation for an acute exacerbation of COPD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Factorial Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in four-metre gait speed (m/s) following nutritional support</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in weight (kg) following nutritional support</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <condition>Respiratory Tract Diseases</condition>
  <condition>Lung Diseases, Obstructive</condition>
  <condition>Bronchitis, Chronic</condition>
  <condition>Pulmonary Emphysema</condition>
  <arm_group>
    <arm_group_label>Food Fortification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Food Fortification</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral Nutritional Supplements</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Nutritional Supplements - Fortisip Compact</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Food fortification</intervention_name>
    <arm_group_label>Food Fortification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oral Nutritional Supplements</intervention_name>
    <arm_group_label>Oral Nutritional Supplements</arm_group_label>
    <other_name>Fortisip Compact, Nutricia Clinical</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to consent&#xD;
&#xD;
          -  Patients at moderate or severe risk of malnutrition&#xD;
&#xD;
          -  Adults over the age of 40&#xD;
&#xD;
          -  Hospitalised with an AECOPD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving long term parental or enteral nutrition&#xD;
&#xD;
          -  Inability to swallow or difficulty liquids&#xD;
&#xD;
          -  Lactose intolerance, galactosaemia, cow's milk protein allergy or intolerance&#xD;
&#xD;
          -  Co-existing active cancer, progressive neurological condition or active GI disorder.&#xD;
&#xD;
          -  Receiving palliative care with expectation of death within 3 months&#xD;
&#xD;
          -  Cognitive dysfunction or unable to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Man, PhD FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Brompton &amp; Harefield NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hillingdon Hospital NHS Foundation Trust</name>
      <address>
        <city>Uxbridge</city>
        <state>Middlesex</state>
        <zip>UB8 3NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>May 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>October 30, 2015</last_update_submitted>
  <last_update_submitted_qc>October 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchitis</mesh_term>
    <mesh_term>Bronchitis, Chronic</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Pulmonary Emphysema</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Emphysema</mesh_term>
  </condition_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/NCT02261350
org study id: 2013LF004H
nct id: NCT02261350
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
To determine the feasibility of delivering different community nutritional interventions to
      chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of
      malnutrition following a hospitalisation for an acute exacerbation of COPD.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Change in four-metre gait speed (m/s) following nutritional support
time frame: Change from baseline to 12 weeks
measure: Change in weight (kg) following nutritional support
time frame: Change from baseline to 12 weeks
measure: Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support
time frame: Change from baseline to 12 weeks
measure: Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support
time frame: Change from baseline to 12 weeks
arm group label: Food Fortification
arm group type: Experimental
description: Food Fortification
arm group label: Oral Nutritional Supplements
arm group type: Experimental
description: Oral Nutritional Supplements - Fortisip Compact
arm group label: Usual Care
arm group type: No Intervention
intervention type: Dietary Supplement
intervention name: Food fortification
arm group label: Food Fortification
intervention type: Dietary Supplement
intervention name: Oral Nutritional Supplements
arm group label: Oral Nutritional Supplements
other name: Fortisip Compact, Nutricia Clinical
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: William Man, PhD FRCP
role: Principal Investigator
affiliation: Royal Brompton & Harefield NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Bronchitis
mesh term: Bronchitis, Chronic
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Pulmonary Emphysema
mesh term: Respiratory Tract Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Emphysema