RecruitingPhase 1Phase 2NCT06040268

Advair HFA in Healthy and HAPE Predisposed Subjects

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


Sponsor

University of Colorado, Denver

Enrollment

60 participants

Start Date

Dec 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Advair HFA and a drug called Placebo for people with altitude edema. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdvair HFA

6 puffs (total: salmeterol 126 ug and fluticasone 270 ug) twice daily

DRUGPlacebo

HFA134a inhaler


Locations(1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

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NCT06040268