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

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ClinicalTrials.gov Identifier: NCT03154645
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Grant S Lipman, Stanford University

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
Acute Mountain Sickness Drug: Ibuprofen Drug: Acetazolamide 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized 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 : August 12, 2017
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 1, 2017


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 Name: Motrin

Active Comparator: acetazolamide
acetazolamide, 125mg, two times a day, through to ascent to high altitude
Drug: Acetazolamide
a diuretic
Other Name: diamox




Primary Outcome Measures :
  1. incidence of acute mountain sickness [ Time Frame: 2 days ]
    incidence of acute mountain sickness by Lake Louise Questionnaire


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154645


Locations
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United States, California
White Mountain Research Station
Bishop, California, United States, 93515
Sponsors and Collaborators
Grant S Lipman

Publications of Results:
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Responsible Party: Grant S Lipman, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03154645     History of Changes
Other Study ID Numbers: 40325
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Ibuprofen
Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases
Acetazolamide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics
Natriuretic Agents