Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude
Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: High Altitude
Intervention: Ibuprofen (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: University of California, San Francisco
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.
Clinical Details
Official title: Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: blood cytokine levelscerebral blood flow
Secondary outcome: pulse oximetry
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- healthy subjects
Exclusion Criteria:
- pregnancy
- contraindication to taking ibuprofen
Locations and Contacts
White Mountain Research Center, Bishop, California 95740, United States; Not yet recruiting Philip Bickler, MD, PhD, Phone: 415-476-1411, Email: bicklerp@anesthesia.ucsf.edu John Feiner, Phone: 4154768624, Email: feinerj@anesthesia.ucsf.edu Philip Bickler, MD, PhD, Principal Investigator
UCSF Hypoxia Research Laboratory, San Francisco, California 94143, United States; Not yet recruiting Paul Au, BS, Phone: 415-476-1412, Email: aupaul@anesthesia.ucsf.edu Philip Bickler, MD, PHD, Phone: 4154761411 Philip Bickler, MD, PhD, Principal Investigator
Additional Information
Starting date: September 2014
Last updated: September 9, 2014
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