<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/NCT02247856</url>
  </required_header>
  <id_info>
    <org_study_id>Valdecir_COPD</org_study_id>
    <nct_id>NCT02247856</nct_id>
  </id_info>
  <brief_title>COPD AND ASSESSMENT OF RADIOLABELED AEROSOL DURING NONINVASIVE VENTILATION</brief_title>
  <official_title>IN VIVO ASSESSMENT OF RADIOLABELED AEROSOL DURING NONINVASIVE VENTILATION IN STABLE COPD: A RANDOMIZED CROSSOVER CLINICAL TRIAL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daniella Cunha Brandao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidade Federal de Pernambuco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Federal de Pernambuco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Beneficial effects from noninvasive ventilation (NIV) in acute COPD are&#xD;
      well-established, but couple to nebulization is still challenging. Aim: To compare&#xD;
      radioaerosol pulmonary deposition and radioaerosol mass balance in the different compartments&#xD;
      (pulmonary and extrapulmonary) using vibrating mesh nebulizer (VMN) and jet nebulizer (JN)&#xD;
      coupled to NIV.Methods: It was a crossover study involving 9 stable moderate to severe COPD&#xD;
      randomly allocated for both phases of the study: Phase 1(NIV+MN,n=9) and phase 2(NIV+JN,n=9).&#xD;
      Bronchodilators were delivered during NIV using a facemask (pressures of 12 cmH2O and 5 cmH2O&#xD;
      - inspiratory and expiratory, respectively). Radioactivity counts were performed using a&#xD;
      gamma camera and regions of interest(ROIs) were delimited. We determine aerosol mass balance&#xD;
      from the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory&#xD;
      filters, and mask as a percentage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>radioaerosol deposition index into the lungs</measure>
    <time_frame>10 months</time_frame>
    <description>Immediately after inhalation, participants sat in a chair with the back positioned in front to the gamma camera (STARCAM 3200 GE, California, USA) to obtain radioactivity counts from the posterior thorax during a period of 300 seconds on a matrix of 256 X 256. After, participants were positioned sitting in front to the gama camera to obtain images from face. Then, the same procedure was performed to analysis deposition in the nebulizer, circuits, inspiratory filter, expiratory filter and face mask. Counts representing stomach were obtained from posterior thorax and corrections for decay of technetium were used to during extrapulmonary measurements</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>radioaerosol mass balance that reached pulmonary and extrapulmonary compartments.</measure>
    <time_frame>10 months</time_frame>
    <description>The analysis of deposition in pulmonary and extrapulmonary compartments was expressed as a percentage from the count in each compartment to the total radioaerosol mass generated by nebulizers. The inhaled radioaerosol was considered the sum of deposition into the upper airways, lungs and stomach.&#xD;
Regions of interest were delimited based on a previous protocol and RDI was expressed as absolute values and was calculated according to the counts generated from each regions of interest.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Noninvasive ventilation+ jet nebulizer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Noninvasive ventilation+ Vibrating Mesh Nebulizer (VMN)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Noninvasive ventilation</intervention_name>
    <description>Bilevel positive pressure (BiPAP Synchrony, Respironics®, Murrysville, Pennsylvania, USA) was applied through face mask (Comfort Full 2, Respironics®, Murrysville, Pennsylvania, USA) attached with straps and pressure adjusted were 12 cmH2O of inspiratory pressure and 5 cmH2O of expiratory pressure after a period of adaptation before beginning the procedure to avoid ventilator-patient asynchrony</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Jet Nebulizer</intervention_name>
    <description>Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. JN (Mist yMax, Air Life, Yorba Linda, USA) was positioned in the circuit using a &quot;T&quot; piece, particle size generation in a 5 µm range (according to the manufacturer information) and flow oxygen tritated at 8 L/min</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vibrating Mesh Nebulizer (VMN)</intervention_name>
    <description>Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. VMN (Aeroneb Solo, Galway, Ireland) was positioned in the mask using an elbow (Elbow Kit, Respironics®, Murrysville, Pennsylvania, USA), particle size generation in a 1 µm and connected to electrical energy.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria were considered as follows: moderate to severe stable COPD (50% ≤ FEV1 &lt;&#xD;
        80% from predicted values or 30% ≤ FEV1 &lt; 50% from predicted values)(4); none exacerbation&#xD;
        in the last six months; age between 18 - 60 years; both sexes; no smoking history; able to&#xD;
        understand verbal commands, and consent to participate in this protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Presence of dyspnea; cardiopulmonary diseases (chronic obstructive pulmonary disease,&#xD;
        pneumonia, cardiac failure, myocardial infarction, pneumothorax); hyperthermia; hemodynamic&#xD;
        instability (heart rate &gt; 150 bpm and systolic blood pressure &lt; 90 mmHg); arrhythmia&#xD;
        absence; pregnancy; and contraindications for use of NIV (29).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valdecir G Filho, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal de Pernambuco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital das Clínicas de Pernambuco</name>
      <address>
        <city>Recife</city>
        <state>Pernambuco</state>
        <zip>50670-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Brandao DC, Lima VM, Filho VG, Silva TS, Campos TF, Dean E, de Andrade AD. Reversal of bronchial obstruction with bi-level positive airway pressure and nebulization in patients with acute asthma. J Asthma. 2009 May;46(4):356-61. doi: 10.1080/02770900902718829.</citation>
    <PMID>19484669</PMID>
  </results_reference>
  <results_reference>
    <citation>Galindo-Filho VC, Brandao DC, Ferreira Rde C, Menezes MJ, Almeida-Filho P, Parreira VF, Silva TN, Rodrigues-Machado Mda G, Dean E, Dornelas de Andrade A. Noninvasive ventilation coupled with nebulization during asthma crises: a randomized controlled trial. Respir Care. 2013 Feb;58(2):241-9. doi: 10.4187/respcare.01371.</citation>
    <PMID>22781558</PMID>
  </results_reference>
  <results_reference>
    <citation>Soroksky A, Stav D, Shpirer I. A pilot prospective, randomized, placebo-controlled trial of bilevel positive airway pressure in acute asthmatic attack. Chest. 2003 Apr;123(4):1018-25. doi: 10.1378/chest.123.4.1018.</citation>
    <PMID>12684289</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 21, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 23, 2014</last_update_submitted>
  <last_update_submitted_qc>September 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Pernambuco</investigator_affiliation>
    <investigator_full_name>Daniella Cunha Brandao</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>nebulizers,</keyword>
  <keyword>noninvasive ventilation</keyword>
  <keyword>COPD</keyword>
  <keyword>scintigraphy,</keyword>
  <keyword>aerosol</keyword>
  <!-- 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/NCT02247856
org study id: Valdecir_COPD
nct id: NCT02247856
lead sponsor: 
collaborator: 
has dmc: Yes
Background: Beneficial effects from noninvasive ventilation (NIV) in acute COPD are
      well-established, but couple to nebulization is still challenging. Aim: To compare
      radioaerosol pulmonary deposition and radioaerosol mass balance in the different compartments
      (pulmonary and extrapulmonary) using vibrating mesh nebulizer (VMN) and jet nebulizer (JN)
      coupled to NIV.Methods: It was a crossover study involving 9 stable moderate to severe COPD
      randomly allocated for both phases of the study: Phase 1(NIV+MN,n=9) and phase 2(NIV+JN,n=9).
      Bronchodilators were delivered during NIV using a facemask (pressures of 12 cmH2O and 5 cmH2O
      - inspiratory and expiratory, respectively). Radioactivity counts were performed using a
      gamma camera and regions of interest(ROIs) were delimited. We determine aerosol mass balance
      from the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory
      filters, and mask as a percentage.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: radioaerosol deposition index into the lungs
time frame: 10 months
description: Immediately after inhalation, participants sat in a chair with the back positioned in front to the gamma camera (STARCAM 3200 GE, California, USA) to obtain radioactivity counts from the posterior thorax during a period of 300 seconds on a matrix of 256 X 256. After, participants were positioned sitting in front to the gama camera to obtain images from face. Then, the same procedure was performed to analysis deposition in the nebulizer, circuits, inspiratory filter, expiratory filter and face mask. Counts representing stomach were obtained from posterior thorax and corrections for decay of technetium were used to during extrapulmonary measurements
measure: radioaerosol mass balance that reached pulmonary and extrapulmonary compartments.
time frame: 10 months
description: The analysis of deposition in pulmonary and extrapulmonary compartments was expressed as a percentage from the count in each compartment to the total radioaerosol mass generated by nebulizers. The inhaled radioaerosol was considered the sum of deposition into the upper airways, lungs and stomach.
Regions of interest were delimited based on a previous protocol and RDI was expressed as absolute values and was calculated according to the counts generated from each regions of interest.
arm group label: Control Group
arm group type: Active Comparator
description: Noninvasive ventilation+ jet nebulizer
arm group label: Experimental Group
arm group type: Experimental
description: Noninvasive ventilation+ Vibrating Mesh Nebulizer (VMN)
intervention type: Other
intervention name: Noninvasive ventilation
description: Bilevel positive pressure (BiPAP Synchrony, Respironics®, Murrysville, Pennsylvania, USA) was applied through face mask (Comfort Full 2, Respironics®, Murrysville, Pennsylvania, USA) attached with straps and pressure adjusted were 12 cmH2O of inspiratory pressure and 5 cmH2O of expiratory pressure after a period of adaptation before beginning the procedure to avoid ventilator-patient asynchrony
arm group label: Control Group
arm group label: Experimental Group
intervention type: Device
intervention name: Jet Nebulizer
description: Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. JN (Mist yMax, Air Life, Yorba Linda, USA) was positioned in the circuit using a "T" piece, particle size generation in a 5 µm range (according to the manufacturer information) and flow oxygen tritated at 8 L/min
arm group label: Control Group
intervention type: Device
intervention name: Vibrating Mesh Nebulizer (VMN)
description: Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. VMN (Aeroneb Solo, Galway, Ireland) was positioned in the mask using an elbow (Elbow Kit, Respironics®, Murrysville, Pennsylvania, USA), particle size generation in a 1 µm and connected to electrical energy.
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Valdecir G Filho, PhD
role: Principal Investigator
affiliation: Universidade Federal de Pernambuco
facility: 
country: Brazil
citation: Brandao DC, Lima VM, Filho VG, Silva TS, Campos TF, Dean E, de Andrade AD. Reversal of bronchial obstruction with bi-level positive airway pressure and nebulization in patients with acute asthma. J Asthma. 2009 May;46(4):356-61. doi: 10.1080/02770900902718829.
PMID: 19484669
citation: Galindo-Filho VC, Brandao DC, Ferreira Rde C, Menezes MJ, Almeida-Filho P, Parreira VF, Silva TN, Rodrigues-Machado Mda G, Dean E, Dornelas de Andrade A. Noninvasive ventilation coupled with nebulization during asthma crises: a randomized controlled trial. Respir Care. 2013 Feb;58(2):241-9. doi: 10.4187/respcare.01371.
PMID: 22781558
citation: Soroksky A, Stav D, Shpirer I. A pilot prospective, randomized, placebo-controlled trial of bilevel positive airway pressure in acute asthmatic attack. Chest. 2003 Apr;123(4):1018-25. doi: 10.1378/chest.123.4.1018.
PMID: 12684289
responsible party type: Sponsor-Investigator
investigator affiliation: Universidade Federal de Pernambuco
investigator full name: Daniella Cunha Brandao
investigator title: PhD