Inhaled Budesonide for Altitude Illness Prevention

Altitude Sickness Clinical Trial

Official title:

Inhaled Budesonide for Altitude Illness Prevention

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02941510
• Other study ID #: 16-2184
• Status: Withdrawn
• Phase: Phase 3
• First received: October 19, 2016
• Last updated: March 9, 2017
• Start date: March 6, 2017
• Est. completion date: March 6, 2017

Study information

• Verified date: March 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 6, 2017
• Est. primary completion date: March 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Altitude Sickness

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Changes in Gene regulation	Comparison of gene regulation involved in acclimatization and altitude illness.	During 18 hours at elevation compared to baseline.