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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 : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Grant S Lipman, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Acute Mountain Sickness
Interventions Drug: Budesonide
Drug: Acetazolamide
Drug: Placebo
Enrollment 103

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Budesonide Acetazolamide Control
Hide Arm/Group Description

Budesonide inhaler as experimental treatment along with placebo pill.

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

Acetazolimide pill as active comparator along with sham inhaler.

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

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

Placebo: Placebo pill and sham inhaler

Period Title: Overall Study
Started 33 35 35
Completed 33 35 35
Not Completed 0 0 0
Arm/Group Title Budesonide Acetazolamide Control Total
Hide Arm/Group Description

Budesonide inhaler as experimental treatment along with placebo pill.

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

Acetazolimide pill as active comparator along with sham inhaler.

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

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

Placebo: Placebo pill and sham inhaler

Total of all reporting groups
Overall Number of Baseline Participants 33 35 35 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 35 participants 35 participants 103 participants
33  (10) 33  (9) 32  (7) 33  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 35 participants 35 participants 103 participants
Female
15
  45.5%
12
  34.3%
21
  60.0%
48
  46.6%
Male
18
  54.5%
23
  65.7%
14
  40.0%
55
  53.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 35 participants 35 participants 103 participants
33 35 35 103
1.Primary Outcome
Title Number of Participants With Acute Mountain Sickness
Hide Description Number of participants with acute mountain sickness (AMS) by Lake Lousie Questionnaire (LLQ)
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Budesonide Acetazolamide Control
Hide Arm/Group Description:

Budesonide inhaler as experimental treatment along with placebo pill.

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

Acetazolimide pill as active comparator along with sham inhaler.

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

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

Placebo: Placebo pill and sham inhaler

Overall Number of Participants Analyzed 33 35 35
Measure Type: Number
Unit of Measure: Count of participants
24 22 15
2.Secondary Outcome
Title Number of Participants With Severe Acute Mountain Sickness
Hide Description Number of participants with severe acute mountain sickness (AMS) by Lake Lousie Questionnaire (LLQ) (score > 5).
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Budesonide Acetazolamide Control
Hide Arm/Group Description:

Budesonide inhaler as experimental treatment along with placebo pill.

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

Acetazolimide pill as active comparator along with sham inhaler.

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

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

Placebo: Placebo pill and sham inhaler

Overall Number of Participants Analyzed 33 35 35
Measure Type: Count of Participants
Unit of Measure: Participants
18
  54.5%
11
  31.4%
19
  54.3%
3.Secondary Outcome
Title Oxygen Saturation
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Budesonide Acetazolamide Control
Hide Arm/Group Description:

Budesonide inhaler as experimental treatment along with placebo pill.

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

Acetazolimide pill as active comparator along with sham inhaler.

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

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

Placebo: Placebo pill and sham inhaler

Overall Number of Participants Analyzed 33 35 35
Mean (Standard Deviation)
Unit of Measure: percent saturation
88.6  (4.1) 88.1  (3.8) 86.4  (5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Budesonide Acetazolamide Control
Hide Arm/Group Description

Budesonide inhaler as experimental treatment along with placebo pill.

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

Acetazolimide pill as active comparator along with sham inhaler.

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

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

Placebo: Placebo pill and sham inhaler

All-Cause Mortality
Budesonide Acetazolamide Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Budesonide Acetazolamide Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Budesonide Acetazolamide Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Grant Lipman
Organization: Stanford University
Phone: 415-290-9286
Responsible Party: Grant S Lipman, Stanford University
ClinicalTrials.gov Identifier: NCT02604173     History of Changes
Other Study ID Numbers: 35330
First Submitted: November 6, 2015
First Posted: November 13, 2015
Results First Submitted: September 23, 2017
Results First Posted: January 18, 2018
Last Update Posted: January 18, 2018