Inhaled Budesonide for Altitude Illness Prevention

Overview

A randomized, double-blinded study administering budesonide, a medication to reduce inflammation in the lungs, to healthy volunteers to examine effects on altitude illness prevention by spending 18 hours overnight at 14,000 ft elevation.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 6, 2017

Detailed Description

A randomized, double-blinded study will be conducted to validate the results of previous literature on the use of budesonide in the prevention of altitude sickness. It will be conducted using healthy participants overseen by experienced wilderness medicine and altitude researchers from the Altitude Research Center at University of Colorado Denver. Participants will be recruited from the Denver community and prescreened for eligibility via phone. 100 participants, after consenting, will have baseline data and blood collected and will begin budesonide therapy 72 hours prior to being taken from Denver to Pikes Peak, where they will be observed at altitude for 18 hours. Patients will have the opportunity to withdraw consent at any time and will be monitored continuously by physician-researchers. Data collection and blood draws will be performed at specific time points and analyzed for efficacy of budesonide vs. placebo in the incidence of altitude sickness.

Interventions

  • Drug: Budesonide
    • Budesonide is FDA approved for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). It works by reducing lung inflammation to increase oxygen uptake by the body. The researchers are examining if this medication can prevent altitude sickness.
  • Other: Placebo
    • Subject(s) will participate in all study activities but will receive placebo.

Arms, Groups and Cohorts

  • Experimental: Budesonide
    • Will participate in all study activities but will receive budesonide.
  • Placebo Comparator: Placebo
    • Will participate in all study activities but will receive placebo.

Clinical Trial Outcome Measures

Primary Measures

  • Changes in Inflammation
    • Time Frame: During 18 hours at elevation compared to baseline.
    • Analysis to compare activity in pro-inflammatory pathways and activity in anti-permeability pathways, as measured by serum markers, between budesonide and placebo.
  • Incidence of Acute Mountain Sickness (AMS)
    • Time Frame: During 18 hours at elevation compared to baseline.
    • Comparison of incidence and severity of acute mountain sickness between budesonide and placebo.
  • Changes in Gene regulation
    • Time Frame: During 18 hours at elevation compared to baseline.
    • Comparison of gene regulation involved in acclimatization and altitude illness.

Participating in This Clinical Trial

Inclusion Criteria

  • healthy, altitude naive, 21-40 years old Exclusion Criteria:

  • smokers – pregnancy – hx of asthma – current inhaled steroid use – those with diseases or disorders known to be affected by hypoxia or the drugs used in this study such as – migraine or other chronic headaches, – sickle cell trait or disease, or – diabetes – history of significant head injury or seizures – taking any medication (over-the-counter or prescription) or herbal supplements – a known hypersensitivity reaction to budesonide – inability to be headache-free when consuming the amount of caffeine in two six ounce cups of coffee or less per day – exposure to high altitude above 2000m in the previous 1 month or – those who have been on an airline flight over six hours (Airplane cabins are pressurized to an elevation that can approximate exposure to high altitude)

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ryan Paterson, MD, DiMM, Principal Investigator, University of Colorado, Denver

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