Trial Outcomes & Findings for Altitude Sickness Prevention and Efficacy of Comparative Treatments (NCT NCT02604173)

NCT ID: NCT02604173

Last Updated: 2018-12-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 103 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2018-12-12

Participant Flow

Participant milestones

Measure	Budesonide Budesonide inhaler as experimental treatment along with placebo pill. Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness	Acetazolamide Acetazolimide pill as active comparator along with sham inhaler. Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness	Control Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator. Placebo: Placebo pill and sham inhaler
Overall Study STARTED	33	35	35
Overall Study COMPLETED	33	35	35
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Altitude Sickness Prevention and Efficacy of Comparative Treatments

Baseline characteristics by cohort

Measure	Budesonide n=33 Participants Budesonide inhaler as experimental treatment along with placebo pill. Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness	Acetazolamide n=35 Participants Acetazolimide pill as active comparator along with sham inhaler. Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness	Control n=35 Participants Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator. Placebo: Placebo pill and sham inhaler	Total n=103 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 10 • n=5 Participants	33 years STANDARD_DEVIATION 9 • n=7 Participants	32 years STANDARD_DEVIATION 7 • n=5 Participants	33 years STANDARD_DEVIATION 9 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants	48 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	23 Participants n=7 Participants	14 Participants n=5 Participants	55 Participants n=4 Participants
Region of Enrollment United States	33 participants n=5 Participants	35 participants n=7 Participants	35 participants n=5 Participants	103 participants n=4 Participants

PRIMARY outcome

Timeframe: 24 hours

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

Outcome measures

Measure	Budesonide n=33 Participants Budesonide inhaler as experimental treatment along with placebo pill. Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness	Acetazolamide n=35 Participants Acetazolimide pill as active comparator along with sham inhaler. Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness	Control n=35 Participants Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator. Placebo: Placebo pill and sham inhaler
Number of Participants With Acute Mountain Sickness	24 Count of participants	22 Count of participants	15 Count of participants

SECONDARY outcome

Timeframe: 24 hours

Number of participants with severe acute mountain sickness (AMS) by Lake Lousie Questionnaire (LLQ) (score > 5).

Outcome measures

Measure	Budesonide n=33 Participants Budesonide inhaler as experimental treatment along with placebo pill. Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness	Acetazolamide n=35 Participants Acetazolimide pill as active comparator along with sham inhaler. Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness	Control n=35 Participants Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator. Placebo: Placebo pill and sham inhaler
Number of Participants With Severe Acute Mountain Sickness	18 Participants	11 Participants	19 Participants

SECONDARY outcome

Timeframe: 24 hours

measurement of oxygen saturation (%) by finger tip pulse oximeter.

Outcome measures

Measure	Budesonide n=33 Participants Budesonide inhaler as experimental treatment along with placebo pill. Budesonide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness	Acetazolamide n=35 Participants Acetazolimide pill as active comparator along with sham inhaler. Acetazolamide: Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness	Control n=35 Participants Sham inhaler as control for budesonide inhaler along with placebo pill as control for acetazolamide comparator. Placebo: Placebo pill and sham inhaler
Oxygen Saturation	88.6 percent saturation Standard Deviation 4.1	88.1 percent saturation Standard Deviation 3.8	86.4 percent saturation Standard Deviation 5

Adverse Events

Budesonide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acetazolamide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Grant Lipman

Stanford University

Phone: 415-290-9286

Email: gslipman@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place