Inhaled Budesonide for Altitude Illness Prevention

NCT02941510 | Withdrawn Phase 3 DMC

• 1 other identifier: 16-2184
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Altitude Sickness

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Budesonide

EXPERIMENTAL

Will participate in all study activities but will receive budesonide.

Drug: Budesonide

Placebo

PLACEBO COMPARATOR

Will participate in all study activities but will receive placebo.

Other: Placebo

Interventions

Budesonide DRUG

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.

Budesonide

Placebo OTHER

Subject(s) will participate in all study activities but will receive placebo.

Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy, altitude naive, 21-40 years old

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Altitude Sickness

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ryan Paterson, MD, DiMM

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 21, 2016
• Study Start: March 6, 2017
• Primary Completion: March 6, 2017
• Study Completion: March 6, 2017
• Last Updated: March 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share