Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude

NCT02233582 | Completed Phase 1

• 2 other identifiers: Ibuprofen and AltitudeIRB#14-14110
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

High Altitude

Keywords

altitude; mountain sickness; ibuprofen; hypoxia

Outcome Measures

Primary Outcomes (2)

• blood cytokine levels

  venous blood sample, once a day

  on days 1 and 2 at sea level, on arrival at altitude and daily for 2 days

• cerebral blood flow

  optical/non-invasive measure of frontal cortex cerebral blood flow with an FDA-approved device

  once daily for 2 days at sea level, on arrival at altitude and once daily at altitude for 2 days

Secondary Outcomes (1)

• pulse oximetry

  once a day for 2 days at sea level, on arrival at altitude and daily for 2 days

Other Outcomes (2)

• cerebral oximetry

  once daily for 2 days at sea level, on arrival at altitude and daily for 2 days

• acute mountain sickness inventory

  once a day at both sea level (2 days) and altitude (2 days)

Study Arms (2)

ibuprofen plus ascent to high altitude

EXPERIMENTAL

subjects randomized to this arm will take ibuprofen 200 mg 3 times daily during ascent and at altitude.

Drug: Ibuprofen

sugar pill plus ascent to high altitude

PLACEBO COMPARATOR

subjects randomized to this arm will receive the placebo

Drug: Sugar pill

Interventions

Ibuprofen DRUG

We are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia.

Also known as: motrin

ibuprofen plus ascent to high altitude

Sugar pill DRUG

sugar pill plus ascent to high altitude

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

White Mountain Research Center

Bishop, California, 95740, United States

Location

UCSF Hypoxia Research Laboratory

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Altitude Sickness; Hypoxia

Interventions

Ibuprofen; Sugars

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Carbohydrates

Study Officials

• Philip Bickler, PhD/MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• John Feiner, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 8, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: June 1, 2017
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: To study completion.
• Access Criteria: De-identified data set only.

Locations

US (2)