Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Phase 1

Completed

• Conditions: Acute Mountain Sickness
• Interventions: Drug: Ibuprofen; Drug: Acetazolamide

• Registration Number: NCT03154645
• Lead Sponsor: Grant S Lipman

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.

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-16
• Study Start: 2017-08-12
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-21
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen	ibuprofen, 600mg, three times a day, through to ascent to high altitude
acetazolamide	Acetazolamide	acetazolamide, 125mg, two times a day, through to ascent to high altitude

Primary Outcome Measures

Name	Time	Method
incidence of acute mountain sickness	2 days	incidence of acute mountain sickness by Lake Louise Questionnaire

Secondary Outcome Measures

Name	Time	Method
severity of acute mountain sickness	2 days	severity of acute mountain sickness by Lake Louise Questionnaire (0-15)
oxygen saturation	2 days	measurement of oxygen saturation (%) by fingertip pulse oximetry
Groningen Sleep Quality Questionnaire (GSQQ)	2 days	Groningen Sleep Quality Questionnaire (GSQQ) (0-14)

Trial Locations

Locations (1)

White Mountain Research Station; 🇺🇸 Bishop, California, United States