Inhaled Budesonide for Altitude Illness Prevention

NCT ID: NCT02941510

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-06
• Study Completion Date: 2017-03-06

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.

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.

Conditions

Altitude Sickness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Budesonide

Will participate in all study activities but will receive budesonide.

Group Type: EXPERIMENTAL

Budesonide

Intervention Type: 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.

Placebo

Will participate in all study activities but will receive placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Paterson, MD, DiMM

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Other Identifiers

16-2184

Identifier Type: -

Identifier Source: org_study_id