Condition: Altitude Edema · Sponsor: University of Colorado, Denver
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.
This description comes directly from the study's public registry record.
James P Maloney, MD · 3037246072 · james.maloney@ucdenver.edu
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| University of Colorado Anschutz Medical Campus | Aurora, Colorado, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06040268