A Double-Blinded, Placebo-Controlled, Randomized, 2 Period, Crossover Phase 1/2a Study to Test the Safety and Efficacy of Advair HFA (Salmeterol and Fluticasone) in Resting and Exercising Healthy and High Altitude Pulmonary Edema (HAPE) Predisposed Subjects

Primary Objective

Investigators at the University of Colorado are conducting research on the ability to exercise under high altitude (low oxygen) conditions. The study is looking at the safety and effects on exercise of a high dose of an inhaled asthma medication (salmeterol/fluticasone, or Advair?) on exercise performance while breathing low-oxygen air.

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Description

The study involves two separate study periods of 12 days each, where you will: • Take the study drug or placebo through a puffer for 7 days. You will not know which drug you are taking during which period • Wear a continuous heart monitor for 12 days • Have blood tests drawn during 5 visits • Complete an exercise performance test while breathing air that has a low oxygen levels (similar to the air at high altitude)

Details
Age
Adult
Eligibility
You may be eligible to participate if you: • Are 18-50 years old • Are generally in good health • Do not use any recreational drugs, tobacco, or vape products
Locations

CTRC Inpatient
Outpatient CTRC

Principal Investigator
Photograph of James Maloney

James Maloney

Study ID

Protocol Number: 23-0463

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