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Corticosteroid
Advair HFA for Altitude Edema (SWIFTARC Trial)
Phase 1 & 2
Recruiting
Led By James P Maloney, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HAPE-susceptible individuals (Study 2 only) must have had a medically documented (hospital admission or emergency room visit) HAPE episode characterized by noncardiogenic pulmonary edema and hypoxemia that occurred during high altitude travel in Colorado and must reside below 3,000 feet (unacclimatized individuals; non-Colorado residents).
Male or female age 18-50 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days of treatment and 7 days of washout
Summary
This trial looks at the safety & effectiveness of high-dose salmeterol/fluticasone for improving exercise performance & preventing pulmonary edema in healthy & HAPE-sensitive individuals.
Who is the study for?
This trial is for healthy individuals aged 18-50, with a BMI between 20 and <35. Participants must be in good health as confirmed by medical exams and tests, agree to follow the study's procedures, and have good veins for IVs. For part of the study, people either need a history of high-altitude pulmonary edema (HAPE) or no HAPE during high altitude exposure.
What is being tested?
The trial is testing Advair HFA against a placebo over seven days to see if it's safe and can improve exercise performance under simulated high-altitude conditions. It also looks at how well it prevents pulmonary edema and boosts exercise capacity in those prone or resistant to HAPE.
What are the potential side effects?
Possible side effects include reactions related to salmeterol/fluticasone such as throat irritation, hoarseness, headache, increased heart rate, tremors, nervousness; however specific side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a severe altitude sickness episode in Colorado and live below 3,000 feet.
Select...
I am between 18 and 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days of treatment and 7 days of washout
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days of treatment and 7 days of washout
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
VO2 max
Secondary study objectives
Aa Gradient
MPAP
blood lactate
+3 moreOther study objectives
Cardiac rhythm (asymptomatic)
Cardiac rhythm (symptomatic)
Drug discontinuation
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Advair HFA (salmeterol 126 ug/fluticasone 270 ug) twice daily for up to 7 daysExperimental Treatment1 Intervention
Participants will inhale salmeterol 126 ug and fluticasone 270 ug twice daily for up to 7 days
Group II: PlaceboPlacebo Group1 Intervention
Participants will inhale placebo (same puff number) twice daily for up to 7 days
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
MTECUNKNOWN
1 Previous Clinical Trials
47 Total Patients Enrolled
United States Department of DefenseFED
917 Previous Clinical Trials
334,639 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,919,920 Total Patients Enrolled
James P Maloney, MDPrincipal InvestigatorUniv. of Colorado, Denver