Clinical trial NCT03154645: Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy
Official title: Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Mountain Sickness
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double blind controlled trial
Primary purpose: PREVENTION

Brief summary: This double blind randomized trial will compare ibuprofen to acetazolamide for the prevention of acute mountain sickness. These drugs have never been directly compared for efficacy. The study population is hikers who are ascending at their own rate under their own power in a true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft Station (BAR), Bancroft Peak, White Mountain, California.

Detailed description: The specific aim of this study is to evaluate if acetazolamide will be similar to ibuprofen (i.e. Ibuprofen being non-inferior) in decreasing the incidence of Acute Mountain Sickness (AMS) in travelers to high altitude. It has been shown that ibuprofen taken 3 times a day 6 hours prior to ascent is effective for the prevention of AMS, with a number needed to treat of 4, decreasing the odds of getting AMS by a third. The efficacy appears to be similar to acetazolamide, with a NNT of 3 -8, although these two medications have not been directly compared in prevention of AMS. Acetazolamide is diuretic that is the only FDA approved AMS prophylactic medication and the most commonly used drug for AMS prevention. Although acetazolamide has been given a 1A indication, it has been shown to limit exercise capabilities at high altitude, and rapid ascent has been shown to attenuate its protective effects. Ibuprofen has been given a IIB recommendation by the Wilderness Medical Society Practice Guidelines, in part because it has not directly compared to acetazolamide. It is unknown if a non-steroidal anti-inflammatory can provide protection from AMS equivalent to acetazolamide.

Eligibility criteria: Inclusion Criteria:

1. Age 18-65 healthy non-pregnant volunteer
2. Sea-level dwelling (live at low elevation \< 4000 ft)
3. Arrange your own transportation to WMRS (Bishop) by Friday evening of study weekend
4. Available for full study duration (Friday PM-Sunday AM)

Exclusion Criteria:

1. Age \<18 or \>65, Pregnant, Live at altitude \>4000 ft
2. Slept at altitude \> 4000ft within 1 week of study
3. Allergic to acetazolamide, sulfa drugs, or non-steroidal anti-inflammatories
4. Taking NSAIDs, Acetazolamide, or Corticosteroids 1 week prior to study
5. Medical History of Brain Tumor, increased brain pressure, pseudotumor cerebri, VP shunts, HACE, or HAPE.

Primary outcomes:
measure: incidence of acute mountain sickness
timeFrame: 2 days
Secondary outcomes:
measure: severity of acute mountain sickness
timeFrame: 2 days
measure: oxygen saturation
timeFrame: 2 days
measure: Groningen Sleep Quality Questionnaire (GSQQ)
timeFrame: 2 days
Other outcomes:
Locations:
city: Bishop
country: United States
facility: White Mountain Research Station
state: California
Study officials:
References:
citation: Burns P, Lipman GS, Warner K, Jurkiewicz C, Phillips C, Sanders L, Soto M, Hackett P. Altitude Sickness Prevention with Ibuprofen Relative to Acetazolamide. Am J Med. 2019 Feb;132(2):247-251. doi: 10.1016/j.amjmed.2018.10.021. Epub 2018 Nov 10.