<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/NCT02233582</url>
  </required_header>
  <id_info>
    <org_study_id>Ibuprofen and Altitude</org_study_id>
    <secondary_id>IRB#14-14110</secondary_id>
    <nct_id>NCT02233582</nct_id>
  </id_info>
  <brief_title>Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude</brief_title>
  <official_title>Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ibuprofen is often taken by travelers to high altitude to treat the symptoms of acute&#xD;
      mountain sickness such as headache and malaise. However, the blunting of inflammation by&#xD;
      ibuprofen may slow the process of acclimatization to altitude, which relies on mediators of&#xD;
      inflammation for adjustments in breathing.&#xD;
&#xD;
      The study randomizes healthy subjects to receive ibuprofen or placebo and then ascend to&#xD;
      altitude (12,500 feet). Blood cytokines and non-invasive measurements of blood and tissue&#xD;
      oxygen levels will be made for 48 hours at altitude. The hypothesis being tested is that&#xD;
      subjects receiving ibuprofen will have lower blood and tissue oxygen levels after 48 hours at&#xD;
      altitude than will placebo subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will begin with 2 days of studies in San Francisco (sea level baseline).&#xD;
      Measurements will include non-invasive measurements of blood and tissue oxygen and venous&#xD;
      blood draws for cytokine levels.&#xD;
&#xD;
      The altitude part of the study involves ascent to the University of California's White&#xD;
      Mountain Research Center Barcroft Laboratory, at 12,500 feet elevation. The subjects will&#xD;
      remain at that altitude for at least 48 hours for measurements of oxygenation and blood&#xD;
      cytokines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>blood cytokine levels</measure>
    <time_frame>on days 1 and 2 at sea level, on arrival at altitude and daily for 2 days</time_frame>
    <description>venous blood sample, once a day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cerebral blood flow</measure>
    <time_frame>once daily for 2 days at sea level, on arrival at altitude and once daily at altitude for 2 days</time_frame>
    <description>optical/non-invasive measure of frontal cortex cerebral blood flow with an FDA-approved device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pulse oximetry</measure>
    <time_frame>once a day for 2 days at sea level, on arrival at altitude and daily for 2 days</time_frame>
    <description>finger pulse oximetry with an FDA approved pulse oximeter</description>
  </secondary_outcome>
  <other_outcome>
    <measure>cerebral oximetry</measure>
    <time_frame>once daily for 2 days at sea level, on arrival at altitude and daily for 2 days</time_frame>
    <description>non-invasive measurements of cerebral oxygenation with an FDA approved device</description>
  </other_outcome>
  <other_outcome>
    <measure>acute mountain sickness inventory</measure>
    <time_frame>once a day at both sea level (2 days) and altitude (2 days)</time_frame>
    <description>standard questionnaire concerning symptoms associated with acute mountain sickness</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>High Altitude</condition>
  <arm_group>
    <arm_group_label>ibuprofen plus ascent to high altitude</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects randomized to this arm will take ibuprofen 200 mg 3 times daily during ascent and at altitude.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sugar pill plus ascent to high altitude</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>subjects randomized to this arm will receive the placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>We are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia.</description>
    <arm_group_label>ibuprofen plus ascent to high altitude</arm_group_label>
    <other_name>motrin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sugar pill</intervention_name>
    <arm_group_label>sugar pill plus ascent to high altitude</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy subjects The group of subjects in this experiment will be composed of healthy&#xD;
             adult volunteers, over age 18 and under age 65, of any ethnic group, in good physical&#xD;
             and mental health. We expect to enroll approximately 20 subjects. The ethnic groups&#xD;
             represented will depend on the ethnicity of those who wish to be subjects, but no&#xD;
             ethnic groups will be specifically sought after or rejected.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be specifically excluded according to the following criteria:&#xD;
&#xD;
          1. History of any clinically significant medical condition, particularly abnormal&#xD;
             respiratory, cardiovascular, neurological, hematological, renal or hepatic function. A&#xD;
             medical history and physical exam will be performed at the screening session for each&#xD;
             subject. We will use this to determine whether the subjects are healthy and without&#xD;
             any history of these conditions. No laboratory workup will be required&#xD;
&#xD;
          2. Regular smokers (more than 1 cigarette or cigar per day).&#xD;
&#xD;
          3. Currently active or recently treated systemic or serious local infection.&#xD;
&#xD;
          4. Recent regular use of prescription medications or regular physician care for any&#xD;
             significant medical condition.&#xD;
&#xD;
          5. A history of high altitude pulmonary edema or high altitude cerebral edema.&#xD;
&#xD;
          6. Recent exposure to altitude (&gt;8000 ft) in the last month or having slept at an&#xD;
             altitude &gt;6000 feet in the last month.&#xD;
&#xD;
          7. Inability to provide written informed consent or to be able to complete the&#xD;
             experiment.&#xD;
&#xD;
          8. Pregnancy as determined by a urine pregnancy test if subjects believe they might be&#xD;
             pregnant&#xD;
&#xD;
          9. Allergy to non-steroid anti-inflammatory drugs (NSAIDs) or subjects reporting history&#xD;
             or symptoms of ulcers or other ibuprofen related contraindications discussed with the&#xD;
             screening physician.&#xD;
&#xD;
         10. Heavy coffee drinkers or caffeine users will be advised that they may suffer rebound&#xD;
             headache when restricted from caffeinated beverages on measurement days, and asked to&#xD;
             carefully consider any continuing participation in the study after abstaining from&#xD;
             caffeine during their first sea level measurements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Bickler, PhD/MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Feiner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>White Mountain Research Center</name>
      <address>
        <city>Bishop</city>
        <state>California</state>
        <zip>95740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Hypoxia Research Laboratory</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>April 2, 2021</last_update_submitted>
  <last_update_submitted_qc>April 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>altitude</keyword>
  <keyword>mountain sickness</keyword>
  <keyword>ibuprofen</keyword>
  <keyword>hypoxia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Altitude Sickness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified data may be shared with colleagues at other University of California campuses or affiliated academic institutions. No subject identifiers will be included.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>To study completion.</ipd_time_frame>
    <ipd_access_criteria>De-identified data set only.</ipd_access_criteria>
  </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/NCT02233582
org study id: Ibuprofen and Altitude
secondary id: IRB#14-14110
nct id: NCT02233582
lead sponsor: 
has dmc: No
Ibuprofen is often taken by travelers to high altitude to treat the symptoms of acute
      mountain sickness such as headache and malaise. However, the blunting of inflammation by
      ibuprofen may slow the process of acclimatization to altitude, which relies on mediators of
      inflammation for adjustments in breathing.

      The study randomizes healthy subjects to receive ibuprofen or placebo and then ascend to
      altitude (12,500 feet). Blood cytokines and non-invasive measurements of blood and tissue
      oxygen levels will be made for 48 hours at altitude. The hypothesis being tested is that
      subjects receiving ibuprofen will have lower blood and tissue oxygen levels after 48 hours at
      altitude than will placebo subjects.
The study will begin with 2 days of studies in San Francisco (sea level baseline).
      Measurements will include non-invasive measurements of blood and tissue oxygen and venous
      blood draws for cytokine levels.

      The altitude part of the study involves ascent to the University of California's White
      Mountain Research Center Barcroft Laboratory, at 12,500 feet elevation. The subjects will
      remain at that altitude for at least 48 hours for measurements of oxygenation and blood
      cytokines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: blood cytokine levels
time frame: on days 1 and 2 at sea level, on arrival at altitude and daily for 2 days
description: venous blood sample, once a day
measure: cerebral blood flow
time frame: once daily for 2 days at sea level, on arrival at altitude and once daily at altitude for 2 days
description: optical/non-invasive measure of frontal cortex cerebral blood flow with an FDA-approved device
measure: pulse oximetry
time frame: once a day for 2 days at sea level, on arrival at altitude and daily for 2 days
description: finger pulse oximetry with an FDA approved pulse oximeter
measure: cerebral oximetry
time frame: once daily for 2 days at sea level, on arrival at altitude and daily for 2 days
description: non-invasive measurements of cerebral oxygenation with an FDA approved device
measure: acute mountain sickness inventory
time frame: once a day at both sea level (2 days) and altitude (2 days)
description: standard questionnaire concerning symptoms associated with acute mountain sickness
arm group label: ibuprofen plus ascent to high altitude
arm group type: Experimental
description: subjects randomized to this arm will take ibuprofen 200 mg 3 times daily during ascent and at altitude.
arm group label: sugar pill plus ascent to high altitude
arm group type: Placebo Comparator
description: subjects randomized to this arm will receive the placebo
intervention type: Drug
intervention name: Ibuprofen
description: We are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia.
arm group label: ibuprofen plus ascent to high altitude
other name: motrin
intervention type: Drug
intervention name: Sugar pill
arm group label: sugar pill plus ascent to high altitude
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philip Bickler, PhD/MD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: John Feiner, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Altitude Sickness
mesh term: Ibuprofen
sharing ipd: Yes
ipd description: Deidentified data may be shared with colleagues at other University of California campuses or affiliated academic institutions. No subject identifiers will be included.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: To study completion.
ipd access criteria: De-identified data set only.