Inhaled Budesonide for Altitude Illness Prevention

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 Overview

• Status: Withdrawn
• Conditions: Altitude Sickness
• Intervention / Treatment: Drug: Budesonide; Other: Placebo

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.

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Budesonide; Will participate in all study activities but will receive budesonide.	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.
PLACEBO_COMPARATOR: Placebo; Will participate in all study activities but will receive placebo.	Other: Placebo; Subject(s) will participate in all study activities but will receive placebo.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Ryan Paterson, MD, DiMM, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2017
• Primary Completion (ACTUAL): March 6, 2017
• Study Completion (ACTUAL): March 6, 2017

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (ESTIMATE): October 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: 16-2184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No