Inhaled Budesonide for Altitude Illness Prevention

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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