<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/NCT02211118</url>
  </required_header>
  <id_info>
    <org_study_id>Nystrom01</org_study_id>
    <nct_id>NCT02211118</nct_id>
  </id_info>
  <brief_title>Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD</brief_title>
  <official_title>Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dayton VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dayton VA Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A variety of medications have been used to treat the anxiety, discomfort, and fear associated&#xD;
      with continuous and sudden episodic breathlessness in patients with advanced respiratory&#xD;
      disease. Opioids and benzodiazepines, used alone or in combination, are commonly prescribed&#xD;
      for this distressing symptom. Clinicians are concerned about the adverse effects of opioids,&#xD;
      especially respiratory depression, so they frequently prescribe benzodiazepines. Recent&#xD;
      studies have shown that benzodiazepine use is associated with increased adverse respiratory&#xD;
      outcomes in older adults with Chronic Obstructive Pulmonary Disease (COPD).&#xD;
&#xD;
      Dexmedetomidine may be an alternative to current drug therapies for breathlessness.&#xD;
      Dexmedetomidine produces a dose dependent sedation, anxiolysis, and analgesia without&#xD;
      respiratory depression or cognitive dysfunction. The drug can be administered intranasally to&#xD;
      induce light to moderate sedation of several hours duration.&#xD;
&#xD;
      The objective of the proposed research, a pilot study, is to assess the dose dependent safety&#xD;
      and efficacy of intranasal dexmedetomidine in clinically stable patients with severe COPD.&#xD;
      This will be accomplished in a staffed acute care setting with routine vital signs monitoring&#xD;
      and pulse oximetry. Patients will be assessed objectively and subjectively for their level of&#xD;
      sedation by validated sedation scales.&#xD;
&#xD;
      This pilot study is an initial investigation of a drug with favorable pharmacologic&#xD;
      properties in this patient population with distressing and difficult to treat symptoms. The&#xD;
      pilot study may provide evidence that a larger trial is needed to confirm the study results,&#xD;
      or evidence that additional study in symptomatic patients and treatment comparison trials&#xD;
      should be pursued.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Observer's Assessment of Alertness/Sedation Scale</measure>
    <time_frame>every 15 minutes up to 5 hours after intranasal desmedetomidine</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Sedation Visual Analog Scale (VAS)</measure>
    <time_frame>Every 15 minutes up to 5 hours after intranasal dexemdetomidine</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Vital Signs</measure>
    <time_frame>Every 5 minutes for 90 minutes, then every 15 minutes for up to 5 hours</time_frame>
    <description>Heart rate, noninvasive blood pressure, respitory rate, pulse oximetry</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>COPD</condition>
  <condition>Sedation</condition>
  <condition>Dexmedetomidine</condition>
  <arm_group>
    <arm_group_label>IN-DEX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be administered 1 mcg/kg or 1.5 mcg/kg intranasal dexemdetomidine (IN-DEX) and monitored for up to 5 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal dexemdetomidine (IN-DEX)</intervention_name>
    <arm_group_label>IN-DEX</arm_group_label>
    <other_name>precedex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe COPD (FEV1 30-50% predicted)&#xD;
&#xD;
          -  Age 45-70&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Class 3&#xD;
&#xD;
          -  Body Mass Index &lt;35 kg/meter squared&#xD;
&#xD;
          -  No prior history of adverse reactions to alpha 2 agonists (dexmedetomidine, clonidine)&#xD;
&#xD;
          -  Women of non-child bearing age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known adverse reaction, allergy or hypersensitivity, to alpha 2 agonists&#xD;
&#xD;
          -  not nothing by mouth (NPO)&#xD;
&#xD;
          -  ASA class &gt;3&#xD;
&#xD;
          -  Home oxygen therapy &gt;2LPM by nasal cannula continuous use&#xD;
&#xD;
          -  Any evidence of nasal mucosal inflammation, irritation, bleeding or ulceration&#xD;
&#xD;
          -  Pregnancy, or possibility of pregnancy&#xD;
&#xD;
          -  Coronary heart disease with stable or unstable angina&#xD;
&#xD;
          -  Baseline heart rate &lt;55 beats per minute&#xD;
&#xD;
          -  Bradyarrhythmia, heart block, presence of pacemaker&#xD;
&#xD;
          -  Congestive Heart Failure or known Cardiomyopathy (Ejection Fraction &lt;40% by ECHO,&#xD;
             MUGA, or myocardial perfusion imaging)&#xD;
&#xD;
          -  Cor pulmonale&#xD;
&#xD;
          -  Liver disease (hepatic transaminases above the upper limit of normal, cirrhosis, end&#xD;
             stage liver disease)&#xD;
&#xD;
          -  diagnosis of moderate to severe Obstructive Sleep Apnea&#xD;
&#xD;
          -  currently enrolled in any other research study involving drugs or devices&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dayton VA Medical Center</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45428</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>July 16, 2019</last_update_submitted>
  <last_update_submitted_qc>July 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>February 13, 2023</submitted>
    <returned>March 8, 2023</returned>
  </pending_results>
  <!-- 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/NCT02211118
org study id: Nystrom01
nct id: NCT02211118
lead sponsor: 
has dmc: Yes
A variety of medications have been used to treat the anxiety, discomfort, and fear associated
      with continuous and sudden episodic breathlessness in patients with advanced respiratory
      disease. Opioids and benzodiazepines, used alone or in combination, are commonly prescribed
      for this distressing symptom. Clinicians are concerned about the adverse effects of opioids,
      especially respiratory depression, so they frequently prescribe benzodiazepines. Recent
      studies have shown that benzodiazepine use is associated with increased adverse respiratory
      outcomes in older adults with Chronic Obstructive Pulmonary Disease (COPD).

      Dexmedetomidine may be an alternative to current drug therapies for breathlessness.
      Dexmedetomidine produces a dose dependent sedation, anxiolysis, and analgesia without
      respiratory depression or cognitive dysfunction. The drug can be administered intranasally to
      induce light to moderate sedation of several hours duration.

      The objective of the proposed research, a pilot study, is to assess the dose dependent safety
      and efficacy of intranasal dexmedetomidine in clinically stable patients with severe COPD.
      This will be accomplished in a staffed acute care setting with routine vital signs monitoring
      and pulse oximetry. Patients will be assessed objectively and subjectively for their level of
      sedation by validated sedation scales.

      This pilot study is an initial investigation of a drug with favorable pharmacologic
      properties in this patient population with distressing and difficult to treat symptoms. The
      pilot study may provide evidence that a larger trial is needed to confirm the study results,
      or evidence that additional study in symptomatic patients and treatment comparison trials
      should be pursued.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Modified Observer's Assessment of Alertness/Sedation Scale
time frame: every 15 minutes up to 5 hours after intranasal desmedetomidine
measure: Sedation Visual Analog Scale (VAS)
time frame: Every 15 minutes up to 5 hours after intranasal dexemdetomidine
measure: Changes in Vital Signs
time frame: Every 5 minutes for 90 minutes, then every 15 minutes for up to 5 hours
description: Heart rate, noninvasive blood pressure, respitory rate, pulse oximetry
arm group label: IN-DEX
arm group type: Experimental
description: Subjects will be administered 1 mcg/kg or 1.5 mcg/kg intranasal dexemdetomidine (IN-DEX) and monitored for up to 5 hours.
intervention type: Drug
intervention name: Intranasal dexemdetomidine (IN-DEX)
arm group label: IN-DEX
other name: precedex
criteria: 
gender: All
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dexmedetomidine
submitted: February 13, 2023
returned: March 8, 2023