<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/NCT03286855</url>
  </required_header>
  <id_info>
    <org_study_id>INCA NEB</org_study_id>
    <nct_id>NCT03286855</nct_id>
  </id_info>
  <brief_title>Effectiveness of Vibrating Mesh Versus Small Volume Nebuliser in Chronic Obstructive Pulmonary Disease (COPD)</brief_title>
  <official_title>A Randomized Controlled Trial of Bronchodilator Delivery by Vibrating Mesh (VM) Nebuliser Versus Small Volume Nebuliser During an Acute Exacerbation of COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beaumont Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aerogen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Beaumont Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      When patients get an attack of COPD, one of the main treatments is regular nebulised&#xD;
      medications called bronchodilators. These medications act by opening up the airways allowing&#xD;
      patients to breathe easier and to reduce shortness of breath. Newer nebulisers may increase&#xD;
      the amount of medication that gets into the lungs compared to the standard nebuliser usually&#xD;
      used in hospital. This study is being done to assess whether increasing the amount of&#xD;
      medication getting into the lungs using these newer nebulisers will help patients recover&#xD;
      from a COPD exacerbation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COPD is a common chronic respiratory disease. It is characterised by repeated episodes of&#xD;
      acute worsening of symptoms of cough, wheeze and breathlessness called exacerbations.&#xD;
      Exacerbations result in patients having to present to hospital for treatment. In Ireland more&#xD;
      than one-fifth of all inpatient hospital days for the treatment of respiratory complaints are&#xD;
      for the treatment of COPD. The administration of bronchodilators (medication to open the&#xD;
      airway) is a central component of the treatment of COPD exacerbation. In the hospital setting&#xD;
      these are most commonly administered via a nebuliser. The standard of care in our institution&#xD;
      is the Hudson micromist small volume nebuliser.&#xD;
&#xD;
      However, previous studies have shown that Vibrating mesh (VM) nebulisers result in greater&#xD;
      deposition of medication to the lungs compared to small volume nebulisers. In addition they&#xD;
      resulted in greater improvements in lung function and breathlessness.&#xD;
&#xD;
      This study will assess the efficacy of the Aerogen Ultra VM nebuliser in a real-world&#xD;
      setting. The VM nebuliser is readily available for use in the clinical setting and is used to&#xD;
      administer bronchodilator therapy, within the terms of its CE Mark. This nebuliser is already&#xD;
      in routine use in hospitals within the Royal College of Surgeons in Ireland (RCSI) hospital&#xD;
      group.&#xD;
&#xD;
      Patients hospitalised with an exacerbation of COPD will be recruited. There will be two study&#xD;
      groups. Group 1 (VM Group): will receive bronchodilator (salbutamol 2.5mg/ipratropium 0.5mg)&#xD;
      by Vibrating Mesh Nebuliser (Aerogen Ultra) with facemask and Group 2 (Standard Hospital&#xD;
      Care): will receive bronchodilator by small volume nebuliser (Hudson Micromist) via facemask&#xD;
      as per standard care.&#xD;
&#xD;
      Both groups will receive bronchodilator therapy four times a day which has already been&#xD;
      prescribed by their medical team, and in accordance with recommended guidelines for treatment&#xD;
      of COPD exacerbations. Patients will use the nebuliser for the duration of hospital stay or a&#xD;
      maximum of 7 days. Lung function and breathlessness scores will be recorded. The aim of this&#xD;
      study is to demonstrate that better medication delivery by VM nebulizer during an&#xD;
      exacerbation of COPD will lead to greater bronchodilation, shorter recovery time and reduced&#xD;
      hospital length of stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>prospective feasibility open-label randomised controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Forced Vital Capacity (FVC)</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Forced spirometry measured at bedside</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Borg breathlessness score</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Change in patient-reported breathlessness as determined by the Borg breathlessness score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Defined as time from randomisation to medical decision to discharge patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Inspiratory Capacity (IC)</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Relaxed spirometry measured at bedside</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of re-exacerbation at Day 30</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>The number of repeat exacerbations following discharged from hospital. Exacerbation defined as an acute change in respiratory symptoms necessitating administration of antibiotics and/or steroids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to re-exacerbation .</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>The time to first repeat exacerbation following discharge.Exacerbation defined as an acute change in respiratory symptoms necessitating administration of antibiotics and/or steroids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life (QOL): to discharge and to Day 30</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>COPD Assessment Test Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personal Satisfaction Score</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>End-user questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Forced Expiratory Volume in one second (FEV1)</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Forced spirometry measured at bedside</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>COPD</condition>
  <condition>Copd Exacerbation Acute</condition>
  <condition>COPD Exacerbation</condition>
  <arm_group>
    <arm_group_label>Vibrating Mesh Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient's admitted with an acute exacerbation of COPD and prescribed nebulised combined salbutamol 2.5mg/ipratropium bromide 0.5mg (Combivent) are randomised to receive their treatment via the Aerogen Ultra (CE 0050) vibrating mesh Nebuliser.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Hospital Care Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient's admitted with an acute exacerbation of COPD and prescribed nebulised combined salbutamol 2.5mg/ipratropium bromide 0.5mg (Combivent) are randomised to receive their treatment via the Hudson micromist small volume nebuliser which is the standard of care at our institution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vibrating Mesh Nebuliser</intervention_name>
    <description>The Aerogen Ultra vibrating mesh nebuliser is an approved 13 485 class II medical device (CE marked) nebuliser licenced for the delivery of physician-prescribed medications for inhalation which are approved for use with a general purpose nebuliser. It has been shown in previous laboratory and clinical studies to have superior drug delivery to standard jet nebulisers.</description>
    <arm_group_label>Vibrating Mesh Group</arm_group_label>
    <other_name>Aerogen Ultra 13 485 class II medical device (CE 0050)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Hospital Care</intervention_name>
    <description>The &quot;standard hospital care&quot; refers to the nebuliser in clinical use currently throughout Beaumont Hospital and used for the administration of nebulised medications. This is the Hudson micromist small volume nebuliser.</description>
    <arm_group_label>Standard Hospital Care Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission with acute exacerbation of COPD within 24 hours of presentation to hospital&#xD;
&#xD;
          -  Age &gt;40&#xD;
&#xD;
          -  Confirmed COPD diagnosis (FEV1/FVC &lt;0.70 on spirometry)&#xD;
&#xD;
          -  Willing to participate in the study and provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Admission for reason other than COPD exacerbation e.g. Heart Failure&#xD;
&#xD;
          -  Acute confusion as per clinical team&#xD;
&#xD;
          -  Allergy or contraindication to combined bronchodilator medication&#xD;
&#xD;
          -  Severe respiratory sepsis as evident by temperature &gt;38 degrees and/or lobar pneumonia&#xD;
             on Chest Radiograph&#xD;
&#xD;
          -  Sustained tachycardia &gt;120bpm&#xD;
&#xD;
          -  Patients with very advanced COPD, admitted for palliative or long term care&#xD;
&#xD;
          -  Patients re-admitted within 90 days who have already been enrolled in the study.&#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>Richard W Costello</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal College of Surgeons in Ireland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beaumont Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>July 17, 2019</last_update_submitted>
  <last_update_submitted_qc>July 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beaumont Hospital</investigator_affiliation>
    <investigator_full_name>Professor Richard Costello</investigator_full_name>
    <investigator_title>Consultant Respiratory Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</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/NCT03286855
org study id: INCA NEB
nct id: NCT03286855
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
When patients get an attack of COPD, one of the main treatments is regular nebulised
      medications called bronchodilators. These medications act by opening up the airways allowing
      patients to breathe easier and to reduce shortness of breath. Newer nebulisers may increase
      the amount of medication that gets into the lungs compared to the standard nebuliser usually
      used in hospital. This study is being done to assess whether increasing the amount of
      medication getting into the lungs using these newer nebulisers will help patients recover
      from a COPD exacerbation.
COPD is a common chronic respiratory disease. It is characterised by repeated episodes of
      acute worsening of symptoms of cough, wheeze and breathlessness called exacerbations.
      Exacerbations result in patients having to present to hospital for treatment. In Ireland more
      than one-fifth of all inpatient hospital days for the treatment of respiratory complaints are
      for the treatment of COPD. The administration of bronchodilators (medication to open the
      airway) is a central component of the treatment of COPD exacerbation. In the hospital setting
      these are most commonly administered via a nebuliser. The standard of care in our institution
      is the Hudson micromist small volume nebuliser.

      However, previous studies have shown that Vibrating mesh (VM) nebulisers result in greater
      deposition of medication to the lungs compared to small volume nebulisers. In addition they
      resulted in greater improvements in lung function and breathlessness.

      This study will assess the efficacy of the Aerogen Ultra VM nebuliser in a real-world
      setting. The VM nebuliser is readily available for use in the clinical setting and is used to
      administer bronchodilator therapy, within the terms of its CE Mark. This nebuliser is already
      in routine use in hospitals within the Royal College of Surgeons in Ireland (RCSI) hospital
      group.

      Patients hospitalised with an exacerbation of COPD will be recruited. There will be two study
      groups. Group 1 (VM Group): will receive bronchodilator (salbutamol 2.5mg/ipratropium 0.5mg)
      by Vibrating Mesh Nebuliser (Aerogen Ultra) with facemask and Group 2 (Standard Hospital
      Care): will receive bronchodilator by small volume nebuliser (Hudson Micromist) via facemask
      as per standard care.

      Both groups will receive bronchodilator therapy four times a day which has already been
      prescribed by their medical team, and in accordance with recommended guidelines for treatment
      of COPD exacerbations. Patients will use the nebuliser for the duration of hospital stay or a
      maximum of 7 days. Lung function and breathlessness scores will be recorded. The aim of this
      study is to demonstrate that better medication delivery by VM nebulizer during an
      exacerbation of COPD will lead to greater bronchodilation, shorter recovery time and reduced
      hospital length of stay.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective feasibility open-label randomised controlled trial
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Forced Vital Capacity (FVC)
time frame: Up to 7 days
description: Forced spirometry measured at bedside
measure: Change in Borg breathlessness score
time frame: Up to 7 days
description: Change in patient-reported breathlessness as determined by the Borg breathlessness score
measure: Length of Hospital Stay
time frame: Up to 7 days
description: Defined as time from randomisation to medical decision to discharge patient
measure: Change in Inspiratory Capacity (IC)
time frame: Up to 7 days
description: Relaxed spirometry measured at bedside
measure: Rate of re-exacerbation at Day 30
time frame: Up to 30 days
description: The number of repeat exacerbations following discharged from hospital. Exacerbation defined as an acute change in respiratory symptoms necessitating administration of antibiotics and/or steroids
measure: Time to re-exacerbation .
time frame: Up to 30 days
description: The time to first repeat exacerbation following discharge.Exacerbation defined as an acute change in respiratory symptoms necessitating administration of antibiotics and/or steroids
measure: Change in quality of life (QOL): to discharge and to Day 30
time frame: Up to 30 days
description: COPD Assessment Test Score
measure: Personal Satisfaction Score
time frame: Up to 7 days
description: End-user questionnaire
measure: Change in Forced Expiratory Volume in one second (FEV1)
time frame: Up to 7 days
description: Forced spirometry measured at bedside
arm group label: Vibrating Mesh Group
arm group type: Experimental
description: Patient's admitted with an acute exacerbation of COPD and prescribed nebulised combined salbutamol 2.5mg/ipratropium bromide 0.5mg (Combivent) are randomised to receive their treatment via the Aerogen Ultra (CE 0050) vibrating mesh Nebuliser.
arm group label: Standard Hospital Care Group
arm group type: Active Comparator
description: Patient's admitted with an acute exacerbation of COPD and prescribed nebulised combined salbutamol 2.5mg/ipratropium bromide 0.5mg (Combivent) are randomised to receive their treatment via the Hudson micromist small volume nebuliser which is the standard of care at our institution.
intervention type: Device
intervention name: Vibrating Mesh Nebuliser
description: The Aerogen Ultra vibrating mesh nebuliser is an approved 13 485 class II medical device (CE marked) nebuliser licenced for the delivery of physician-prescribed medications for inhalation which are approved for use with a general purpose nebuliser. It has been shown in previous laboratory and clinical studies to have superior drug delivery to standard jet nebulisers.
arm group label: Vibrating Mesh Group
other name: Aerogen Ultra 13 485 class II medical device (CE 0050)
intervention type: Device
intervention name: Standard Hospital Care
description: The "standard hospital care" refers to the nebuliser in clinical use currently throughout Beaumont Hospital and used for the administration of nebulised medications. This is the Hudson micromist small volume nebuliser.
arm group label: Standard Hospital Care Group
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Richard W Costello
role: Principal Investigator
affiliation: Royal College of Surgeons in Ireland
facility: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: Beaumont Hospital
investigator full name: Professor Richard Costello
investigator title: Consultant Respiratory Physician
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
sharing ipd: No