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Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03154645
Acronym
ASPIRATE
Enrollment
92
Registered
2017-05-16
Start date
2017-08-12
Completion date
2017-10-01
Last updated
2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Mountain Sickness

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.

Interventions

DRUGIbuprofen

non-steroidal anti-inflammatory drug

DRUGAcetazolamide

a diuretic

Sponsors

Grant S Lipman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

visually identical pills

Intervention model description

randomized double blind controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
incidence of acute mountain sickness2 daysincidence of acute mountain sickness by Lake Louise Questionnaire

Secondary

MeasureTime frameDescription
severity of acute mountain sickness2 daysseverity of acute mountain sickness by Lake Louise Questionnaire (0-15)
oxygen saturation2 daysmeasurement of oxygen saturation (%) by fingertip pulse oximetry
Groningen Sleep Quality Questionnaire (GSQQ)2 daysGroningen Sleep Quality Questionnaire (GSQQ) (0-14)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026