Advair HFA in Healthy and HAPE Predisposed Subjects
Status:
Recruiting
Trial end date:
2026-11-15
Target enrollment:
Participant gender:
Summary
The current protocol is composed of two studies. The first study is designed to carefully
evaluate the safety of high-dose salmeterol/fluticasone (Advair HFA) versus placebo
(hydrofluoroalkane, HFA) administration over 7 days, as well as the efficacy of the study
drug to increase exercise performance, in healthy individuals exercising under hypoxic,
simulated high-altitude conditions (Phase 1/2a study). The second study will examine
sensitive measures of cardiopulmonary function using invasive cardiopulmonary testing, in
both HAPE-sensitive and HAPE-resistant individuals, to assess the potential efficacy of
salmeterol/fluticasone to prevent pulmonary edema and to enhance exercise capacity (Phase 2a)
in these individuals.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Colorado, Denver
Collaborator:
United States Department of Defense
Treatments:
Fluticasone Fluticasone-Salmeterol Drug Combination Norflurane Salmeterol Xinafoate