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

NCT ID: NCT02233582

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-06-30

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.

Conditions

High Altitude

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

ibuprofen plus ascent to high altitude

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

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

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

sugar pill plus ascent to high altitude

subjects randomized to this arm will receive the placebo

Group Type: PLACEBO_COMPARATOR

Sugar pill

Intervention Type: DRUG

Interventions

Ibuprofen

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

Sugar pill

Intervention Type: DRUG

Other Intervention Names

motrin

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:

1. 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

2. Regular smokers (more than 1 cigarette or cigar per day).

3. Currently active or recently treated systemic or serious local infection.

4. Recent regular use of prescription medications or regular physician care for any significant medical condition.

5. A history of high altitude pulmonary edema or high altitude cerebral edema.

6. Recent exposure to altitude (>8000 ft) in the last month or having slept at an altitude >6000 feet in the last month.

7. Inability to provide written informed consent or to be able to complete the experiment.

8. Pregnancy as determined by a urine pregnancy test if subjects believe they might be pregnant

9. 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.

10. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Bickler, PhD/MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

John Feiner, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

White Mountain Research Center

Bishop, California, United States

UCSF Hypoxia Research Laboratory

San Francisco, California, United States

Countries

United States

Other Identifiers

IRB#14-14110

Identifier Type: OTHER

Identifier Source: secondary_id

Ibuprofen and Altitude

Identifier Type: -

Identifier Source: org_study_id