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Corticosteroid

Advair HFA (salmeterol 126 ug/fluticasone 270 ug) twice daily for up to 7 days for Altitude Edema (SWIFTARC Trial)

Q: Is there an age limit on the individuals who can participate in this trial?

To be eligible for the study, participants must fall within the 18-50 year age bracket.

Q: What is the current sample size for this research study?

Affirmative. According to clinicaltrials.gov, this therapeutic trial, initially posted on December 12th 2023 and last updated on the 13th of the same month, is actively recruiting participants. In total 60 individuals must be enrolled from a single site.

Q: Can the general public currently enlist in this experiment?

Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting participants and was first published on December 12th 2023 with subsequent updates being made on the 13th of that same month. The trial requires 60 individuals be enrolled at one site location.

Q: Are there any eligibility criteria I must fulfill in order to join this medical experiment?

This trial is searching for 60 individuals, aged 18-50 with altitude edema. To be considered eligible, each patient must provide written consent and meet the following requirements: a BMI between 20 and 35 kg/m2; good health as evaluated by medical history, physical examination, vital signs (blood pressure, heart rate etc.), clinical laboratory tests (CBC etc); venous access to collect blood samples; <a href="https://www.withpower.com/clinical-trials/colorado">Colorado</a> residents who have had an episode of hypoxemia at high altitude or no evidence of HAPE during high altitude travel in Colorado (for study 2 only).

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

Awards & highlights

SWIFTARC Trial 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.Check my eligibility

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.See study design

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.

SWIFTARC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a severe altitude sickness episode in Colorado and live below 3,000 feet.

Select...

I am between 18 and 50 years old.

SWIFTARC Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days of treatment and 7 days of washout for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

VO2 max

Secondary outcome measures

Aa Gradient

MPAP

blood lactate

+3 more

Other outcome measures

Cardiac rhythm (asymptomatic)

Cardiac rhythm (symptomatic)

Drug discontinuation

+2 more

SWIFTARC Trial 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

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

MTECUNKNOWN

United States Department of DefenseFED

865 Previous Clinical Trials

327,639 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,466 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit on the individuals who can participate in this trial?

"To be eligible for the study, participants must fall within the 18-50 year age bracket."

Answered by AI

What is the current sample size for this research study?

"Affirmative. According to clinicaltrials.gov, this therapeutic trial, initially posted on December 12th 2023 and last updated on the 13th of the same month, is actively recruiting participants. In total 60 individuals must be enrolled from a single site."

Answered by AI

Can the general public currently enlist in this experiment?

"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting participants and was first published on December 12th 2023 with subsequent updates being made on the 13th of that same month. The trial requires 60 individuals be enrolled at one site location."

Answered by AI

Are there any eligibility criteria I must fulfill in order to join this medical experiment?

"This trial is searching for 60 individuals, aged 18-50 with altitude edema. To be considered eligible, each patient must provide written consent and meet the following requirements: a BMI between 20 and 35 kg/m2; good health as evaluated by medical history, physical examination, vital signs (blood pressure, heart rate etc.), clinical laboratory tests (CBC etc); venous access to collect blood samples; Colorado residents who have had an episode of hypoxemia at high altitude or no evidence of HAPE during high altitude travel in Colorado (for study 2 only)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Advair HFA in Healthy and HAPE Predisposed Subjects

James Maloney 2023. "Advair HFA in Healthy and HAPE Predisposed Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06040268.