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

High Altitude Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233582
• Other study ID #: Ibuprofen and Altitude
• Secondary ID: IRB#14-14110
• Status: Completed
• Phase: Phase 1
• Start date: September 2014
• Est. completion date: June 2017

Study information

• Verified date: April 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Altitude Sickness
• High Altitude

Intervention

Drug:
• Ibuprofen
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

Locations

Country	Name	City	State
United States	White Mountain Research Center	Bishop	California
United States	UCSF Hypoxia Research Laboratory	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cerebral oximetry	non-invasive measurements of cerebral oxygenation with an FDA approved device	once daily for 2 days at sea level, on arrival at altitude and daily for 2 days
Other	acute mountain sickness inventory	standard questionnaire concerning symptoms associated with acute mountain sickness	once a day at both sea level (2 days) and altitude (2 days)
Primary	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
Primary	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	pulse oximetry	finger pulse oximetry with an FDA approved pulse oximeter	once a day for 2 days at sea level, on arrival at altitude and daily for 2 days