Clinical Trial: Altitude Sickness Prevention and Efficacy of Comparative Treatments

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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
Sponsor: Stanford University

Current Primary Outcome: Incidence of acute mountain sickness [ Time Frame: 24 hours ]

Incidence of acute mountain sickness (AMS) by Lake Lousie Questionnaire (LLQ)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pulmonary function testing - FVC [ Time Frame: 24 hours ]
    Spirometry measured forced vital capacity: FVC: [(Volume in Liters): deep breath in, blow out as fast and completely as possible
  • Pulmonary function testing - FEV1 [ Time Frame: 24 hours ]
    Spirometry measured Forced Expiratory Volume in 1 second, FEV1: large airway assessment, early in exhalation, Rate in Liters/sec.
  • Pulmonary function testing - PEFR [ Time Frame: 24 hours ]
    Spirometry measured Peak Expiratoy Flow, PEFR: Liters / sec.exhalation, Rate in Liters/sec.
  • Severity of acute mountain sickness [ Time Frame: 24 hours ]
    Severity of acute mountain sickness (AMS) by Lake Lousie Questionnaire (LLQ) (0- 15)
  • oxygen saturation [ Time Frame: 24 hours ]
    measurement of oxygen saturation (%) by finger tip pulse oximeter.


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: November 6, 2015
Date Started: August 2016
Date Completion:
Last Updated: October 26, 2016
Last Verified: October 2016