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Advair HFA in Healthy and HAPE Predisposed Subjects

NCT06040268 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • Altitude Edema

Interventions

DRUG

Advair HFA

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

DRUG

Placebo

HFA134a inhaler

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • James P Maloney, MD · Univ. of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2026-12-01
Completion
2026-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06040268 on ClinicalTrials.gov