Actively Recruiting
Advair HFA in Healthy and HAPE Predisposed Subjects
Led by University of Colorado, Denver · Updated on 2025-09-22
60
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Advair HFA in Healthy and HAPE Predisposed Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before joining the study
- Male or female aged 18 to 50 years
- Body mass index (BMI) between 20 and less than 35 kg/m2
- Willingness to follow all study treatments and procedures
- Good health confirmed by medical history, physical exam, vital signs, lab tests, and resting ECG
- Adequate veins for IV insertion and blood sampling
- For Study 2, HAPE-susceptible individuals must have had a documented HAPE episode during Colorado high altitude travel and live below 3,000 feet
- For Study 2, HAPE-resistant individuals must have no history of HAPE during Colorado high altitude travel and live below 3,000 feet
- For Study 1, healthy controls must be Colorado residents
You will not qualify if you...
- Participation in another clinical trial within 30 days (except observational studies)
- Blood or plasma donation within last month, or more than 500 ml blood donation in past 3 months
- Female subjects who are pregnant, breastfeeding, planning pregnancy, or unwilling to use effective birth control
- Known impaired liver function
- Abnormal lab results beyond safety limits (e.g., kidney function, electrolytes, liver enzymes, blood counts)
- Clinically significant abnormal ECG or history of serious heart rhythm conditions
- History of heart attack, stroke, or heart failure
- Use of blood thinners (except aspirin) or certain medications including beta-blockers, beta-2 agonists, phosphodiesterase-5 inhibitors
- Recent active COVID-19 or viral respiratory infection within 30 days
- Use of medications affecting study drug metabolism or strong enzyme inhibitors/inducers
- Claustrophobia or PTSD limiting use of breathing masks
- Essential tremor requiring medication or limiting handwriting
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
James P Maloney, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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