NCT02604173

Brief Summary

This study is designed to be the first to examine the novel drug budesonide for prevention of acute mountain sickness in comparison to acetazolamide and in the context of rapid ascent to high altitude. The investigators will accomplish these objectives with a prospective, double blinded view of a large population of hikers who are ascending at their own rate in a true hiking environment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 18, 2018

Completed
Last Updated

December 12, 2018

Status Verified

November 1, 2018

Enrollment Period

1 month

First QC Date

November 6, 2015

Results QC Date

September 23, 2017

Last Update Submit

November 21, 2018

Conditions

Acute Mountain Sickness

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Acute Mountain Sickness

    Number of participants with acute mountain sickness (AMS) by Lake Lousie Questionnaire (LLQ)

    24 hours

Secondary Outcomes (2)

  • Number of Participants With Severe Acute Mountain Sickness

    24 hours

  • Oxygen Saturation

    24 hours

Study Arms (3)

Budesonide

EXPERIMENTAL

Budesonide inhaler as experimental treatment along with placebo pill.

Drug: Budesonide

Acetazolamide

ACTIVE COMPARATOR

Acetazolimide pill as active comparator along with sham inhaler.

Drug: Acetazolamide

Control

SHAM COMPARATOR

Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator.

Drug: Placebo

Interventions

BudesonideDRUG

Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness

Also known as: entocort, pulmicort
Budesonide
AcetazolamideDRUG

Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness

Also known as: Diamox
Acetazolamide
PlaceboDRUG

Placebo pill and sham inhaler

Also known as: sugar pill
Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and Female
  • Sea level-dwelling hikers
  • Between ages 18-65

You may not qualify if:

  • History of allergy to acetazolamide or budesonide (or other corticosteroids)
  • Taken NSAIDs, acetazolamide, or corticosteroids in the one week prior to study enrollment.
  • Hazardous medical conditions which precludes the ability to moderately hike to high altitude including: sickle cell anemia, asthma, or COPD, severe anemia, or severe coronary arterial disease.
  • Pregnancy or suspected pregnancy.
  • Participants who are younger than 18 years of age and more than 65
  • Sleep above 4'000 elevation in the preceding 1 week.
  • History of asthma or COPD
  • Current symptoms of an acute upper respiratory illness.
  • Unable to complete a moderately strenuous hike at high altitude.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Owens Valley Lodge - White Mountain Research Station

Bishop, California, 93514, United States

Location

Related Publications (1)

  • Lipman GS, Pomeranz D, Burns P, Phillips C, Cheffers M, Evans K, Jurkiewicz C, Juul N, Hackett P. Budesonide Versus Acetazolamide for Prevention of Acute Mountain Sickness. Am J Med. 2018 Feb;131(2):200.e9-200.e16. doi: 10.1016/j.amjmed.2017.05.034. Epub 2017 Jun 28.

    PMID: 28668540RESULT

MeSH Terms

Conditions

Altitude Sickness

Interventions

BudesonideAcetazolamideSugars

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbohydrates

Results Point of Contact

Title
Dr. Grant Lipman
Organization
Stanford University
gslipman@stanford.edu
415-290-9286

Study Officials

  • Grant S Lipman, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Department of Emergency Medicine

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 13, 2015

Study Start

August 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 12, 2018

Results First Posted

January 18, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)