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Altitude Sickness Prevention and Efficacy of Comparative Treatments (ASPECT)

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ClinicalTrials.gov Identifier: NCT02604173
Recruitment Status : Completed
First Posted : November 13, 2015
Results First Posted : January 18, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Grant S Lipman, Stanford University

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.

Condition or disease Intervention/treatment Phase
Acute Mountain Sickness Drug: Budesonide Drug: Acetazolamide Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Altitude Sickness Prevention and Efficacy of Comparative Treatments
Study Start Date : August 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Budesonide
Budesonide inhaler as experimental treatment along with placebo pill.
Drug: Budesonide
Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness
Other Name: entocort, pulmicort

Active Comparator: Acetazolamide
Acetazolimide pill as active comparator along with sham inhaler.
Drug: Acetazolamide
Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness
Other Name: Diamox

Sham Comparator: Control
Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator.
Drug: Placebo
Placebo pill and sham inhaler
Other Name: sugar pill




Primary Outcome Measures :
  1. Number of Participants With Acute Mountain Sickness [ Time Frame: 24 hours ]
    Number of participants with acute mountain sickness (AMS) by Lake Lousie Questionnaire (LLQ)


Secondary Outcome Measures :
  1. Number of Participants With Severe Acute Mountain Sickness [ Time Frame: 24 hours ]
    Number of participants with severe acute mountain sickness (AMS) by Lake Lousie Questionnaire (LLQ) (score > 5).

  2. Oxygen Saturation [ Time Frame: 24 hours ]
    measurement of oxygen saturation (%) by finger tip pulse oximeter.



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. Male and Female
  2. Sea level-dwelling hikers
  3. Between ages 18-65

Exclusion Criteria:

  1. History of allergy to acetazolamide or budesonide (or other corticosteroids)
  2. Taken NSAIDs, acetazolamide, or corticosteroids in the one week prior to study enrollment.
  3. 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.
  4. Pregnancy or suspected pregnancy.
  5. Participants who are younger than 18 years of age and more than 65
  6. Sleep above 4'000 elevation in the preceding 1 week.
  7. History of asthma or COPD
  8. Current symptoms of an acute upper respiratory illness.
  9. Unable to complete a moderately strenuous hike at high altitude.

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): NCT02604173


Locations
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United States, California
Owens Valley Lodge - White Mountain Research Station
Bishop, California, United States, 93514
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Grant S Lipman, MD Stanford University

Publications of Results:
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Responsible Party: Grant S Lipman, Associate Professor Department of Emergency Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02604173     History of Changes
Other Study ID Numbers: 35330
First Posted: November 13, 2015    Key Record Dates
Results First Posted: January 18, 2018
Last Update Posted: December 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases
Budesonide
Acetazolamide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents