Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Acute Mountain Sickness Clinical Trial

— ASPIRATE  

Official title:

Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154645
• Other study ID #: 40325
• Status: Completed
• Phase: Phase 1
• Start date: August 12, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: November 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness

Intervention

Drug:
• Ibuprofen
non-steroidal anti-inflammatory drug
• Acetazolamide
a diuretic

Locations

Country	Name	City	State
United States	White Mountain Research Station	Bishop	California

Sponsors (1)

Lead Sponsor	Collaborator
Grant S Lipman

Country where clinical trial is conducted

United States, 

References & 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. 2018 Nov 9. pii: S0002-9343(18)31044-1. doi: 10.1016/j.amjmed.2018.10.021. [Epub ahead o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of acute mountain sickness	incidence of acute mountain sickness by Lake Louise Questionnaire	2 days
Secondary	severity of acute mountain sickness	severity of acute mountain sickness by Lake Louise Questionnaire (0-15)	2 days
Secondary	oxygen saturation	measurement of oxygen saturation (%) by fingertip pulse oximetry	2 days
Secondary	Groningen Sleep Quality Questionnaire (GSQQ)	Groningen Sleep Quality Questionnaire (GSQQ) (0-14)	2 days