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ASPIRATE: Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Sponsor
Grant S Lipman (Other)
Overall Status
Completed
CT.gov ID
NCT03154645
Collaborator
(none)
92
Enrollment
1
Location
2
Arms
1.6
Actual Duration (Months)
56
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized double blind controlled trialrandomized double blind controlled trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
visually identical pills
Primary Purpose:
Prevention
Official Title:
Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy
Actual Study Start Date :
Aug 12, 2017
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ibuprofen

ibuprofen, 600mg, three times a day, through to ascent to high altitude

Drug: Ibuprofen
non-steroidal anti-inflammatory drug
Other Names:
  • Motrin

    		•
    Active Comparator: acetazolamide

    acetazolamide, 125mg, two times a day, through to ascent to high altitude

    Drug: Acetazolamide
    a diuretic
    Other Names:
  • diamox

    		•

    Outcome Measures

    Primary Outcome Measures

    1. incidence of acute mountain sickness [2 days]

      incidence of acute mountain sickness by Lake Louise Questionnaire

    Secondary Outcome Measures

    1. severity of acute mountain sickness [2 days]

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

    2. oxygen saturation [2 days]

      measurement of oxygen saturation (%) by fingertip pulse oximetry

    3. Groningen Sleep Quality Questionnaire (GSQQ) [2 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 White Mountain Research Station Bishop California United States 93515

    Sponsors and Collaborators

    • Grant S Lipman

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Grant S Lipman, Principal Investigator, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03154645
    Other Study ID Numbers:
    • 40325
    First Posted:
    May 16, 2017
    Last Update Posted:
    Nov 26, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Altitude Sickness
    Ibuprofen
    Acetazolamide

    Study Results

    No Results Posted as of Nov 26, 2018