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OpenTrials
Completed

NCT Number: NCT03154645

Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

White Mountain Research Station

Bishop, California, 93515, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ibuprofen

Drug

non-steroidal anti-inflammatory drug

Other names: Motrin

Acetazolamide

Drug

a diuretic

Other names: diamox

Primary outcomes

  1. incidence of acute mountain sickness

    Time frame: 2 days

    incidence of acute mountain sickness by Lake Louise Questionnaire

Secondary outcomes

  1. severity of acute mountain sickness

    Time frame: 2 days

    severity of acute mountain sickness by Lake Louise Questionnaire (0-15)

  2. oxygen saturation

    Time frame: 2 days

    measurement of oxygen saturation (%) by fingertip pulse oximetry

  3. Groningen Sleep Quality Questionnaire (GSQQ)

    Time frame: 2 days

    Groningen Sleep Quality Questionnaire (GSQQ) (0-14)

Sponsors and collaborators

Lead sponsor

Grant S Lipman

Other

Registry information

Acronym: ASPIRATE

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 16, 2017
Registry last updated
Nov 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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