Advair HFA in Healthy and HAPE Predisposed Subjects

Conditions

• Altitude Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Advair HFA — DRUG
  6 puffs (total: salmeterol 126 ug and fluticasone 270 ug) twice daily
• Placebo — DRUG
  HFA134a inhaler

Study Details

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.

Key Dates

Start date

Dec 12, 2023

Status verified

Sep 2025

Primary completion

Dec 1, 2026

Completion

Dec 15, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Advair HFA (salmeterol 126 ug/fluticasone 270 ug) twice daily for up to 7 days
  Participants will inhale salmeterol 126 ug and fluticasone 270 ug twice daily for up to 7 days
• Placebo Comparator: Placebo
  Participants will inhale placebo (same puff number) twice daily for up to 7 days

Primary Outcome Measure

VO2 max [ Time Frame: day 3 of treatment ]

Central Contacts

• James P Maloney, MD
  3037246072
  [email protected]

Locations (1)

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