A Randomized Controlled Trial of Altitude Sickness Prevention and Efficacy of Comparative Treatments

Enrollment:

A total of One hundred healthy male and female participants (group of 25 at a time) will be enrolled by study administrators at Owens Valley Lab, White Mountain Research Station. Pregnant women will be excluded. The study enrollment period will run for approximately 12 days over 4 weekends in August 2016. Advertisement of the study at sea level locals in and around Stanford University as well as email chains with other outdoor groups will attempt to gather a cohort of sea-level participants.

Study:

Eligible participants will be randomized in a double blind fashion the morning of ascent to acetazolamide 125 mg PO bid and empty inhaler, budesonide (200 mcg) inhaler bid and visually matched placebo pill, or visually matched placebo and empty inhaler. After informed consent is signed, participants will complete the baseline demographics sheet, LLQ, have pulse oximetry readings, and perform pulmonary function testing prior to taking the study medications. Participants will take the study capsules and inhaler before they leave from OVL, in order to reveal any significant acute adverse reactions before they leave for higher altitude. In the highly unlikely event of an adverse reaction, the participant will be in close proximity to study administrators who will have first aid medicines to treat allergic reactions (Benadryl, Ranitidine, Prednisone, Epinephrine), and communication to BAR where the code can be broken for medical evaluation. In the morning healthy participants without adverse reactions will drive to the Barcroft Gate 11,700', continue on foot to the Barcroft Research Station (BAR) at 12,500'. The study subjects will be allowed to hike at their own pace with minimal restrictions including no travel above 13,054' (Barcroft Summit). The participants will spend the night at BAR where they will be evaluated within 6 hours of their arrival and the morning after (LLQ, pulse oximetry, pulmonary function testing, side effects data, and compliance). After data collection the morning after arrival, the study will be completed for each participant. Participants with significant illness will be removed from the trial and appropriate safety measures taken (Twenty-four hour access to truck evacuation to lower elevations at OVL - the definitive treatment for AMS). Every effort will be made to secure the incomplete data of those who abort the study early. The highest scoring AMS data will be used for primary and secondary outcome analysis.

Procedures: