High AltitudePhase 1NCT02233582
Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude
A Phase 1 study testing Ibuprofen and Sugar pill in people with High Altitude, run by University of California, San Francisco at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High Altitude
- What is being tested?
- Ibuprofen and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
White Mountain Research Center
Bishop, California, 95740
UCSF Hypoxia Research Laboratory
San Francisco, California, 94143
About this study
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.
Read the 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
- Being tested
- Ibuprofen, Sugar pill
- Keywords
- altitude, mountain sickness, ibuprofen, hypoxia
- Medical subject headings
- Altitude Sickness, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called motrin
We are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia.
Sugar pillDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ibuprofen |
| sugar pill plus ascent to high altitude | Placebo comparator | subjects randomized to this arm will receive the placebo Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood cytokine levels
venous blood sample, once a day
Measured: 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
Measured: 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
finger pulse oximetry with an FDA approved pulse oximeter
Measured: once a day for 2 days at sea level, on arrival at altitude and daily for 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High AltitudeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Bickler, PhD/MD, Principal investigator, University of California, San FranciscoJohn Feiner, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233582
- Sponsor's protocol ID
- Ibuprofen and Altitude
- Other IDs
- IRB#14-14110
- Status last verified
- Apr 2021
- First submitted
- 3 Sep 2014
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Deidentified data may be shared with colleagues at other University of California campuses or affiliated academic institutions. No subject identifiers will be included.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-steroidal Anti-inflammatory Drugs (NSAIDS) on Acclimatization to High Altitude
- ClinicalTrials.gov ID
- NCT02233582
- Acronym / sponsor ID
- Ibuprofen and Altitude
- Conditions
- High Altitude
- Keywords
- altitude, mountain sickness, ibuprofen, hypoxia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ibuprofen plus ascent to high altitude | Experimental | Drug: Ibuprofensubjects randomized to this arm will take ibuprofen 200 mg 3 times daily during ascent and at altitude. |
| sugar pill plus ascent to high altitude | Placebo comparator | Drug: Sugar pillsubjects randomized to this arm will receive the placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: motrinWe are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia. | Drug | ibuprofen plus ascent to high altitude |
| Sugar pill | Drug | sugar pill plus ascent to high altitude |
Primary outcome
blood cytokine levels
Time frame: on days 1 and 2 at sea level, on arrival at altitude and daily for 2 days
venous blood sample, once a day
cerebral blood flow
Time frame: once daily for 2 days at sea level, on arrival at altitude and once daily at altitude for 2 days
optical/non-invasive measure of frontal cortex cerebral blood flow with an FDA-approved device
1 secondary outcome
pulse oximetry
Time frame: once a day for 2 days at sea level, on arrival at altitude and daily for 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: Yes. Deidentified data may be shared with colleagues at other University of California campuses or affiliated academic institutions. No subject identifiers will be included.
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Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease at High Altitude
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Bickler, PhD/MD principal investigator
University of California, San Francisco
John Feiner, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibuprofen and Sugar pill in people with High Altitude, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood cytokine levels (time frame: on days 1 and 2 at sea level, on arrival at altitude and daily for 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.