BridgeMD
New treatment option for Chronic Obstructive Pulmonary Disease
Official title : Vascular Function in Health and Disease
ClinicalTrials.gov ID: NCT02966665
What this study is testing
What is BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate?
BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic obstructive pulmonary disease.
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
- Many control mechanisms exist which successfully match the supply of blood with the metabolic demand of various tissues under wide-ranging conditions. One primary regulator of vasomotion and thus perfusion to the muscle tissue is the host of chemical factors originating from the vascular endothelium and the muscle tissue, which collectively sets the level of vascular tone.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Healthy Young Volunteers: 18-30 years of age with no diseases or conditions that would affect their participation in the study
- Healthy Older Controls: volunteers 65 years of age or older with no diseases or conditions that would affect their participation in the study
- Coronary Angiography people: patients undergoing routine coronary angiography
- Chronic Obstructive Pulmonary Disease people: patients diagnosed with mild to moderate COPD
- Pulmonary Arterial Hypertension people: patients with idiopathic or heritable Group 1 pulmonary arterial hypertension
You likely can't join if
- Severe COPD (use of supplemental oxygen, or have a one-second forced expiratory volume of less than 30% predicted)
- History of myocardial infarction
- History of percutaneous coronary revascularization
- History of coronary artery bypass grafting
- Unstable angina pectoris
- History of variant angina
See the full eligibility criteria
- Healthy Young Volunteers: 18-30 years of age with no diseases or conditions that would affect their participation in the study
- Healthy Older Controls: volunteers 65 years of age or older with no diseases or conditions that would affect their participation in the study
- Coronary Angiography people: patients undergoing routine coronary angiography
- Chronic Obstructive Pulmonary Disease people: patients diagnosed with mild to moderate COPD
- Pulmonary Arterial Hypertension people: patients with idiopathic or heritable Group 1 pulmonary arterial hypertension
- Heart Failure people: patients with Class I, II or III New York Heart Association symptoms of Heart Failure
- Hypertension people: patients diagnosed with chronic high blood pressure
- Severe COPD (use of supplemental oxygen, or have a one-second forced expiratory volume of less than 30% predicted)
- History of myocardial infarction
- History of percutaneous coronary revascularization
- History of coronary artery bypass grafting
- Unstable angina pectoris
- History of variant angina
- Ejection fraction \< 50%
- Significant renal disease (Glomerular Filtration Rate \< 50 mL/min/1.73m2)
- people whose medical care or safety may be at risk from undergoing a Magnetic Resonance Imaging examination (e.g. pacemaker, metal implants, certain types of heart valves)
- Subject is pregnant
- Subject has physical ailments (other than COPD, PAH, HF, or hypertension) that would prevent them from study participation in the judgment of the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, 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.