Back to resultsEffects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude
Primary Purpose
High Altitude
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Sugar pill
Sponsored by
About this trial
This is an interventional basic science trial for High Altitude focused on measuring altitude, mountain sickness, ibuprofen, hypoxia
Eligibility Criteria
Inclusion Criteria:
- healthy subjects The group of subjects in this experiment will be composed of healthy adult volunteers, over age 18 and under age 65, of any ethnic group, in good physical and mental health. We expect to enroll approximately 20 subjects. The ethnic groups represented will depend on the ethnicity of those who wish to be subjects, but no ethnic groups will be specifically sought after or rejected.
Exclusion Criteria:
Subjects will be specifically excluded according to the following criteria:
- History of any clinically significant medical condition, particularly abnormal respiratory, cardiovascular, neurological, hematological, renal or hepatic function. A medical history and physical exam will be performed at the screening session for each subject. We will use this to determine whether the subjects are healthy and without any history of these conditions. No laboratory workup will be required
- Regular smokers (more than 1 cigarette or cigar per day).
- Currently active or recently treated systemic or serious local infection.
- Recent regular use of prescription medications or regular physician care for any significant medical condition.
- A history of high altitude pulmonary edema or high altitude cerebral edema.
- Recent exposure to altitude (>8000 ft) in the last month or having slept at an altitude >6000 feet in the last month.
- Inability to provide written informed consent or to be able to complete the experiment.
- Pregnancy as determined by a urine pregnancy test if subjects believe they might be pregnant
- Allergy to non-steroid anti-inflammatory drugs (NSAIDs) or subjects reporting history or symptoms of ulcers or other ibuprofen related contraindications discussed with the screening physician.
- Heavy coffee drinkers or caffeine users will be advised that they may suffer rebound headache when restricted from caffeinated beverages on measurement days, and asked to carefully consider any continuing participation in the study after abstaining from caffeine during their first sea level measurements.
Sites / Locations
- White Mountain Research Center
- UCSF Hypoxia Research Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ibuprofen plus ascent to high altitude
sugar pill plus ascent to high altitude
Arm Description
subjects randomized to this arm will take ibuprofen 200 mg 3 times daily during ascent and at altitude.
subjects randomized to this arm will receive the placebo
Outcomes
Primary Outcome Measures
blood cytokine levels
venous blood sample, once a day
cerebral blood flow
optical/non-invasive measure of frontal cortex cerebral blood flow with an FDA-approved device
Secondary Outcome Measures
pulse oximetry
finger pulse oximetry with an FDA approved pulse oximeter
Full Information
NCT ID
NCT02233582
First Posted
September 3, 2014
Last Updated
April 2, 2021
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02233582
Brief Title
Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude
Official Title
Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Altitude
Keywords
altitude, mountain sickness, ibuprofen, hypoxia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ibuprofen plus ascent to high altitude
Arm Type
Experimental
Arm Description
subjects randomized to this arm will take ibuprofen 200 mg 3 times daily during ascent and at altitude.
Arm Title
sugar pill plus ascent to high altitude
Arm Type
Placebo Comparator
Arm Description
subjects randomized to this arm will receive the placebo
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
motrin
Intervention Description
We are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia.
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Primary Outcome Measure Information:
Title
blood cytokine levels
Description
venous blood sample, once a day
Time Frame
on days 1 and 2 at sea level, on arrival at altitude and daily for 2 days
Title
cerebral blood flow
Description
optical/non-invasive measure of frontal cortex cerebral blood flow with an FDA-approved device
Time Frame
once daily for 2 days at sea level, on arrival at altitude and once daily at altitude for 2 days
Secondary Outcome Measure Information:
Title
pulse oximetry
Description
finger pulse oximetry with an FDA approved pulse oximeter
Time Frame
once a day for 2 days at sea level, on arrival at altitude and daily for 2 days
Other Pre-specified Outcome Measures:
Title
cerebral oximetry
Description
non-invasive measurements of cerebral oxygenation with an FDA approved device
Time Frame
once daily for 2 days at sea level, on arrival at altitude and daily for 2 days
Title
acute mountain sickness inventory
Description
standard questionnaire concerning symptoms associated with acute mountain sickness
Time Frame
once a day at both sea level (2 days) and altitude (2 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy subjects The group of subjects in this experiment will be composed of healthy adult volunteers, over age 18 and under age 65, of any ethnic group, in good physical and mental health. We expect to enroll approximately 20 subjects. The ethnic groups represented will depend on the ethnicity of those who wish to be subjects, but no ethnic groups will be specifically sought after or rejected.
Exclusion Criteria:
Subjects will be specifically excluded according to the following criteria:
History of any clinically significant medical condition, particularly abnormal respiratory, cardiovascular, neurological, hematological, renal or hepatic function. A medical history and physical exam will be performed at the screening session for each subject. We will use this to determine whether the subjects are healthy and without any history of these conditions. No laboratory workup will be required
Regular smokers (more than 1 cigarette or cigar per day).
Currently active or recently treated systemic or serious local infection.
Recent regular use of prescription medications or regular physician care for any significant medical condition.
A history of high altitude pulmonary edema or high altitude cerebral edema.
Recent exposure to altitude (>8000 ft) in the last month or having slept at an altitude >6000 feet in the last month.
Inability to provide written informed consent or to be able to complete the experiment.
Pregnancy as determined by a urine pregnancy test if subjects believe they might be pregnant
Allergy to non-steroid anti-inflammatory drugs (NSAIDs) or subjects reporting history or symptoms of ulcers or other ibuprofen related contraindications discussed with the screening physician.
Heavy coffee drinkers or caffeine users will be advised that they may suffer rebound headache when restricted from caffeinated beverages on measurement days, and asked to carefully consider any continuing participation in the study after abstaining from caffeine during their first sea level measurements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Bickler, PhD/MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Feiner, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
White Mountain Research Center
City
Bishop
State/Province
California
ZIP/Postal Code
95740
Country
United States
Facility Name
UCSF Hypoxia Research Laboratory
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan 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 Sharing Time Frame
To study completion.
IPD Sharing Access Criteria
De-identified data set only.
Learn more about this trial
Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude
We'll reach out to this number within 24 hrs