Brief Title
Inhaled Budesonide for Altitude Illness Prevention
Official Title
Inhaled Budesonide for Altitude Illness Prevention
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Changes in Inflammation
Condition
Altitude Sickness
Intervention
Budesonide
Study Arms / Comparison Groups
Budesonide
Description: Will participate in all study activities but will receive budesonide.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
March 6, 2017
Completion Date
March 6, 2017
Primary Completion Date
March 6, 2017
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)
Gender
All
Ages
21 Years - 40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Ryan Paterson, MD, DiMM, ,
Administrative Informations
NCT ID
NCT02941510
Organization ID
16-2184
Responsible Party
Sponsor
Study Sponsor
University of Colorado, Denver
Study Sponsor
Ryan Paterson, MD, DiMM, Principal Investigator, University of Colorado, Denver
Verification Date
March 2017