Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy
ASPIRATE
1 other identifier
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
May 16, 2017
CompletedStudy Start
First participant enrolled
August 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedNovember 26, 2018
November 1, 2018
2 months
May 11, 2017
November 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of acute mountain sickness
incidence of acute mountain sickness by Lake Louise Questionnaire
2 days
Secondary Outcomes (3)
severity of acute mountain sickness
2 days
oxygen saturation
2 days
Groningen Sleep Quality Questionnaire (GSQQ)
2 days
Study Arms (2)
Ibuprofen
ACTIVE COMPARATORibuprofen, 600mg, three times a day, through to ascent to high altitude
acetazolamide
ACTIVE COMPARATORacetazolamide, 125mg, two times a day, through to ascent to high altitude
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grant S Lipmanlead
Study Sites (1)
White Mountain Research Station
Bishop, California, 93515, United States
Related Publications (1)
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.
PMID: 30419226RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- visually identical pills
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 11, 2017
First Posted
May 16, 2017
Study Start
August 12, 2017
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
November 26, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share