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New treatment option for Altitude Edema
Official title Advair HFA in Healthy and HAPE Predisposed Subjects
ClinicalTrials.gov ID: NCT06040268
What this study is testing
What is Advair HFA?
Advair HFA is an investigational medicine, given as an once-daily, being studied as a potential treatment for altitude edema.
Also referred to as salmeterol and fluticasone in hydrofluoroalkane (HFA) propellant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Written informed consent signed prior to entry into the study.
- Male or female age 18-50 years of age
- BMI ≥ 20 and \< 35 kg/m2
- Agreement to comply with the study-required interventions and treatment during the full duration of the study.
- In good health as determined by screening medical history, physical examination, vital signs (blood pressure, heart rate, respiratory rate and...
You likely can't join if
- Currently participating in or has been enrolled in another clinical trial within the last 30 days (observational studies are acceptable).
- Donation of any blood or plasma in the last month, or donation of \> 500 milliliters (ml) of blood within the 3 months preceding study drug...
- Female people of childbearing potential with positive serum pregnancy (beta human chorionic gonadotropin) test, who are breastfeeding, plan to become...
- Known history of impaired liver function
- Clinically significant laboratory abnormalities (one retest is allowed at the discretion of the Investigator and Medical Monitor), defined as:
- Impaired renal function as estimated glomerular filtration rate \< 60 mL/min/1.73 m2) as estimated using the Chronic Kidney Disease Epidemiology...
See the full eligibility criteria
- Written informed consent signed prior to entry into the study.
- Male or female age 18-50 years of age
- BMI ≥ 20 and \< 35 kg/m2
- Agreement to comply with the study-required interventions and treatment during the full duration of the study.
- In good health as determined by screening medical history, physical examination, vital signs (blood pressure, heart rate, respiratory rate and temperature), clinical laboratory tests (CBC, protime (PT) (INR)/partial...
- Adequate peripheral venous access for IV insertion and blood sample collection (assessments will be made prior to undergoing further assessments).
- 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...
- HAPE-resistant individuals (Study 2 only) will have had no evidence of HAPE during high altitude travel in Colorado, and must reside below 3,000 feet (unacclimatized; often being travel partners of HAPE-susceptible...
- Healthy controls (Study 1 only) will all be Colorado residents.
- Currently participating in or has been enrolled in another clinical trial within the last 30 days (observational studies are acceptable).
- Donation of any blood or plasma in the last month, or donation of \> 500 milliliters (ml) of blood within the 3 months preceding study drug administration.
- Female people of childbearing potential with positive serum pregnancy (beta human chorionic gonadotropin) test, who are breastfeeding, plan to become pregnant during the study, or decline to either be abstinent or use...
- Known history of impaired liver function
- Clinically significant laboratory abnormalities (one retest is allowed at the discretion of the Investigator and Medical Monitor), defined as:
- Impaired renal function as estimated glomerular filtration rate \< 60 mL/min/1.73 m2) as estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at screening.(81)
- Serum Potassium \< 3.2 millimolar (mM)
- aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 2x upper reference limit
- international normalized ratio (INR) \> 1.5
- Fasting serum triglycerides \> 500 mg/dL (lipemic serum affects assays)
- TSH \ 5 milliunits/Liter (mU/L)
- Hemoglobin \< 12.0 g/dL
- Bilirubin \> 2, unless consistent with Gilbert's disorder (indirect bilirubinemia)
- Platelet count \< 100,000/µL
- Any other abnormality deemed by the Investigator to exceed normal safety limits for this study or exclude subject participation.
- Cardiovascular conditions:
- Clinically significant abnormal electrocardiogram at screening:
- Clinically significant abnormal ECG results including but not limited to complete left or right bundle branch block; other ventricular conduction block (except for incomplete bundle branch blocks, with a Q to R to S...
- Any history of congenital or acquired long QT syndrome
- Any history of uncorrected re-entrant supraventricular tachycardia, atrial fibrillation, sinus tachycardia (\> 100 bpm at rest), or ventricular tachycardia.
- Evidence of conduction abnormality including QTc prolongation on ECG, defined as \> 450 msec for men and \> 470 msec for women
- Unstable angina pectoris, history of myocardial infarction (MI), transient ischemic attack (TIA) or stroke within 3 months prior to screening, or people who have ever undergone percutaneous coronary intervention or a...
- New York Heart Association Functional Class I-IV congestive heart failure (any congestive heart failure)
- Use of any blood thinner (e.g. novel oral anticoagulant, coumadin/warfarin). Use of aspirin is acceptable for study and will not need to be discontinued prior to involvement in the study. Use of a P2Y12 inhibitor (such...
- Use of any phosphodiesterase-5 inhibitors (as prescribed medications or obtained by other means) such as sildenafil, tadalafil, or vardenafil (as they may enhance hypoxic exercise performance)
- Infectious conditions: o Active Coronavirus Disease 2019 (COVID-19) or any viral upper respiratory infection suspected by symptoms and/or confirmed by nasal swab polymerase chain reaction (PCR) or rapid antigen within...
- Concomitant Medications:
- Nonselective beta-blockers including propranolol, carvedilol, and labetalol (due to antagonization of beta-2 agonist effects)
- Use of any inhaled or oral beta-2 receptor agonists, or oral theophylline
- Non-potassium sparing diuretics (due to hypokalemia risks)
- The use of any medication known to be a strong inhibitor or strong inducer of cytochrome P (CYP) 3A4 or 3A5 enzymes (cytochrome P450 isoenzymes) that metabolize salmeterol.(66) Also, any medication that has been...
- Use of monoamine oxidase inhibitors or tricyclic antidepressants within 2 weeks of screening
- Prescription amphetamines or other sympathetic stimulants used for disorders such as narcolepsy, somnolence, or attention deficit disorder
- History of claustrophobia or post traumatic stress disorder that would limit use of gas breathing masks or mouthpieces.
- Essential tremor limiting handwriting, or any tremor requiring medication.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.