A Phase 1 interventional study of Maximum Exercise Tests and BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate in Chronic Obstructive Pulmonary Disease, Pulmonary Artery Hypertension and Heart Failure, sponsored by D. Walter Wray. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by D. Walter Wray · Phase 1, Interventional, and Basic science
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Among 1,278 studies in Pulmonary Disease, Chronic Obstructive with a site in United States — 137 open to participants now, 172 under way, 20 of them phase 3. Pulmonary Disease, Chronic Obstructive · United States.
Among the 1,278 studies in Pulmonary Disease, Chronic Obstructive with a site in United States, this one is the 253rd largest by planned enrollment of the 1,037 interventional ones that give a count, is one of 64 that started in 2008, is one of 91 in phase 1, reaches primary completion later than 160 of the 171 other live ones, and was the 748th registered.
5,521 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →137 of the 1,278 studies in Pulmonary Disease, Chronic Obstructive with a site in United States are open now. Recruiting first, the newest first:
Cedars-Sinai Medical Center · Sites in United States
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States
Ages 40–80
Johns Hopkins University · Sites in United States
Ages 18–75 · Healthy volunteers
Enanta Pharmaceuticals, Inc · Sites in United States
Ages 18+
Regeneron Pharmaceuticals · Sites in United States
Ages 40+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,278 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 117 · Phase 2 230 · Phase 3 238 · Phase 4 98
First in 1994; this study’s year is marked. 64 started in 2008.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 420 is above the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 100 across the 1,037 interventional studies, 171 across the 237 observational. Of the 1,018 that completed or were terminated, 502 (49%) have results posted.
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603 of 1,278 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with D. Walter Wray as lead sponsor.
D. Walter Wray has 1 study filed under Pulmonary Disease, Chronic Obstructive — fewer than ten, so there is no comparison to draw.
62 of the studies in Pulmonary Disease, Chronic Obstructive with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05265299Phase 3Johns Hopkins UniversityTrial to Determine Effective Aspirin Dose in COPD | 2026-12 |
| NCT05878769Phase 3Hoffmann-La RocheA Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) | 2027-06-30 |
| NCT07555483Phase 3Grifols Therapeutics LLCA Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD) | 2027-09-30 |
| NCT04968249University of MichiganMichigan Early Disease Progression Cohort | 2026-12 |
| NCT05879211Duke UniversityGoal Concordant Care Learning Laboratory | 2026-12 |
Add all 62 to your calendar (.ics) → With an account.
Among the 1,278 studies in Pulmonary Disease, Chronic Obstructive with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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. With advancing age and in many disease states, deleterious adaptations in the production and sensitivity of these vasodilator and vasoconstrictor substances may be observed, leading to a reduction in skeletal muscle blood flow and compromised perfusion to the muscle tissue. Adequate perfusion is particularly important during exercise to meet the increased metabolic demand of the exercising tissue, and thus any condition that reduces tissue perfusion may limit the capacity for physical activity. As it is now well established that regular physical activity is a key component in maintaining cardiovascular health with advancing age, there is a clear need for further studies in populations where vascular dysfunction is compromised, with the goal of identifying the mechanisms responsible for the dysfunction and exploring whether these maladaptations may be remediable. Thus, to better understand the etiology of these vascular adaptations in health and disease, the current proposal is designed to study changes in vascular function with advancing age, and also examine peripheral vascular changes in patients suffering from chronic obstructive pulmonary disease (COPD), Sepsis, Pulmonary Hypertension, and cardiovascular disease. While there are clearly a host of vasoactive substances which collectively act to govern vasoconstriction both at rest and during exercise, four specific pathways that may be implicated have been identified in these populations: Angiotensin-II (ANG-II), Endothelin-1 (ET-1), Nitric Oxide (NO), and oxidative stress.
Angiotensin-II (ANG-II) is the end-product of the renin-angiotensin cascade, and acts as a potent endogenous vasoconstrictor through binding to the angiotensin receptor (AT1) on arteriolar vascular smooth muscle. With advancing age, there is a notable decline in plasma renin activity accompanied by decrements in circulating ANG-II and an increase in AT1 receptor density. However, the functional consequence of this age-related adaptation of the renin-angiotensin system (RAS) on the peripheral circulation is not well understood. Likewise, in recent years it has become apparent that cardiovascular disease is a major cause of morbidity in COPD, which may be related to vascular dysfunction and associated adoption of a sedentary lifestyle. In these patients, changes in RAS activity have been linked to peripheral vascular dysfunction, with compelling evidence for improvements in peripheral oxygen use following angiotensin-converting enzyme (ACE) inhibition. Like the aging population, systematic studies evaluating AT1 receptor sensitivity and the efficacy of AT1 receptor blockade on peripheral hemodynamics have not been undertaken.
The ubiquitous substance nitric oxide (NO) is now recognized as a key pathway for endothelium-dependent vasodilation, with the bioavailability of NO serving as an indicator for overall vascular health. Cardiac risk factors have been shown to cause impairment in endothelial vasodilator function in both the peripheral and coronary arteries. Coronary vascular dysfunction is an important phase in atherogenesis and is associated with myocardial ischemia. Furthermore, peripheral vascular function has been linked to coronary vascular dysfunction which could have important clinical implications in terms of health screening. Impaired endothelium-dependent vasodilation has been associated with the elderly, patients with COPD, and most cardiovascular diseases including pulmonary hypertension, and heart failure (HF), though the functional consequence of this adaptation on peripheral blood flow regulation remains unclear. Thus, we propose the use of a compound which inhibits the enzyme responsible for NO production in endothelial cells, N-monomethyl-L-arginine (L-NMMA), to temporarily block production of NO and thus determine the importance of this pathway at rest and during physical activity. Additionally, we propose the use of acetylcholine (Ach) to determine endothelial-dependent vasodilation and sodium nitroprusside (SNP) and nitroglycerin (NTG) to determine the endothelial-independent vasodilation in the coronary arteries and the periphery. Oxidative stress associated with aging has been shown to reduce vascular function and antioxidant supplementation restores vascular function to levels that are indistinguishable from healthy young adults. The manner by which this improvement in vascular function occurs is not known by may be acting through a NO dependent mechanism.
Histamine has been reported to mediate sustained post-exercise vasodilation through histamine-1 (H1) and histamine-2 (H2) receptor activity, which results in a \~50% elevation in femoral artery blood flow (above resting levels) that lasts for more than 100 minutes after a single bout of moderate-intensity dynamic exercise. Vasodilation can be markedly reduced by giving either fexofenadine (Allegra, a selective H1-receptor antagonist) or ranitidine (Zantac, a selective H2-receptor antagonist). The combination of H1/H2 blockade abolishes \~80% of the post-exercise vasodilation seen after whole-body exercise such as cycling and this observation has been observed in multiple studies in young sedentary, recreationally active, and endurance trained men and women. The impact of histamine on the post-exercise vasodilatory response is substantial; however, the role of H1/H2 receptors in regulating skeletal muscle blood flow during exercise is unknown. Thus, we intend to investigate the role of H1/H2 receptors in the regulation of skeletal muscle blood during exercise as this may be an important pathway in age and disease related reductions in blood flow during exercise.
Exercise training and rehabilitation can be used as an alternative approach to combat the deleterious effects oxidative stress on aging and disease. An effective exercise training intervention can decrease sympathetic nervous system activity, improve arterial compliance and vascular endothelial function, and alter the pro- and antioxidant balance resulting in improved endogenous antioxidant defense mechanisms. Moreover, exercise training concomitantly improves musculoskeletal strength and function, glucose regulation and insulin sensitivity, cardiovascular function, body composition, blood chemistry (decreased triglyceride and cholesterol levels), and overall well-being. The physiologic effect of an exercise rehabilitation program in diseases such as COPD, and pulmonary arterial hypertension (PAH) is incompletely understood. However, recent studies suggest that exercise training in this patient population is well tolerated and associated with clinically significant physiologic improvements as well as improvements in various quality of life scores.
A unique feature of the proposed studies identified herein is the inclusion of a novel methodological approach to comprehensively evaluate the functional outcome of the proposed pharmacologic interventions. The recent development of a unique combination of nuclear magnetic resonance (NMR) techniques by members of our group enables near-simultaneous measurements of both muscle perfusion and metabolism in vivo. The arterial spin labeling (ASL) technique allows the measurement of both spatially and temporally resolved quantification of perfusion, while the kinetics of phosphocreatine (PCr) depletion and recovery provide high resolution measurements of muscle energetics. The interweaving of these imaging and spectroscopic modules provides the opportunity for determination of skeletal muscle perfusion and metabolism kinetics during and following the stress of physical exercise. Thus, this NMR-based approach, combined with direct measures of muscle fatigue, offers the potential to further define the individual and collective contribution of these variables to the attenuated limb blood flow in the elderly and in patients with COPD and PAH.
We propose that each of these pathways outlined above represent an avenue by which vascular function is compromised in the elderly and in patients with COPD, PAH and cardiovascular disease. However, because these pathways are not mutually exclusive, the proposed studies are designed to systematically evaluate hemodynamic responses to intra-arterial or intravenous administration of pharmacologic agents specific for the AT1 receptor (ANG-II and Diovan, AT1 agonist and antagonist, respectively), the Endothelin receptor Type-A (ETA receptor) (BQ-123, ETA antagonist), and the NO pathway (L-NMMA, Ach, and SNP) both before and after exercise training.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy volunteers between the ages of 18 and 30 years with no diseases or conditions that would affect their participation in the study, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Other: Maximum Exercise Tests · Drug: BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate · Drug: BQ-123 · Drug: Fexofenadine, Ranitidine · Other: Angiotensin-II, Valsartan · Drug: Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine, Phentolamine · Drug: BQ-123, MitoQ, BH4
Healthy volunteers 65 years of age or older with no diseases or conditions that would affect their participation in the study, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Other: Maximum Exercise Tests · Drug: BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate · Drug: BQ-123 · Drug: Fexofenadine, Ranitidine · Other: Angiotensin-II, Valsartan · Drug: Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine, Phentolamine · Drug: BQ-123, MitoQ, BH4
Patients undergoing routine coronary angiography, but who do not require intracoronary procedures or have history of myocardial disease, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Other: Maximum Exercise Tests · Drug: BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate · Drug: BQ-123 · Drug: Fexofenadine, Ranitidine · Other: Angiotensin-II, Valsartan · Drug: Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine, Phentolamine · Drug: BQ-123, MitoQ, BH4
Patients diagnosed with mild to moderate COPD, but not severe COPD patients, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Other: Maximum Exercise Tests · Drug: BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate · Drug: BQ-123 · Drug: Fexofenadine, Ranitidine · Other: Angiotensin-II, Valsartan · Drug: Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine, Phentolamine · Drug: BQ-123, MitoQ, BH4
Patients with idiopathic or heritable Group 1 pulmonary arterial hypertension, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Other: Maximum Exercise Tests · Drug: BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate · Drug: BQ-123 · Drug: Fexofenadine, Ranitidine · Other: Angiotensin-II, Valsartan · Drug: Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine, Phentolamine · Drug: BQ-123, MitoQ, BH4
Patients with Class I - III New York Heart Association symptoms of Heart Failure who are not anemic or taking medications that affect blood clotting, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Other: Maximum Exercise Tests · Drug: BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate · Drug: BQ-123 · Drug: Fexofenadine, Ranitidine · Other: Angiotensin-II, Valsartan · Drug: Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine, Phentolamine · Drug: BQ-123, MitoQ, BH4
Patients with chronic high blood pressure, but with less than severe hypertension, administered various treatments to assess their effect on blood flow and metabolic demand of tissues under wide-ranging conditions, including Maximum Exercise Tests, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid, L-Ascorbate, BQ-123, Fexofenadine, Ranitidine, Angiotensin-II, Valsartan, Acetylcholine, Sodium Nitroprusside, Norepinephrine, Phentolamine and MitoQ.
Other: Maximum Exercise Tests · Drug: BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate · Drug: BQ-123 · Drug: Fexofenadine, Ranitidine · Other: Angiotensin-II, Valsartan · Drug: Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine, Phentolamine · Drug: BQ-123, MitoQ, BH4
Graded exercise test to volitional exhaustion (stationary bike or treadmill), maximal handgrip test, maximal leg extension test, and maximal plantar flexion test.
Drug pages: Sapropterin · Omega-N-Methylarginine · Ascorbic Acid · Vitamin E · Thioctic Acid
Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test, passive leg movement test, exercise bouts, electromyography and exercise training regimen at baseline and following treatment with Nitric Oxide blockade via infusion of N-monomethyl-L-arginine (L-NMMA) (0.4 mg/kg/min), antioxidant cocktail (Vitamin C, Vitamin E, alpha-lipoic acid) ingestion, L-ascorbate injection, BH4 ingestion.
Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test and exercise bouts at baseline and following treatment with endothelin-1 receptor antagonist BQ-123 (D-tryptamine-D-aspartic acid-L-proline-D-valine-L-leucine).
Drug pages: Fexofenadine · Ranitidine
Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test and exercise bouts at baseline and following treatment with Histamine H1 receptor antagonist fexofenadine (Allegra) and Histamine H2 receptor antagonist ranitidine (Zantac).
Also known as: Allegra, Zantac
Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test, muscle sympathetic nerve activity measurement, and exercise bouts at baseline and following treatment with Angiotensin-II receptor agonist (angiotensin-II) and antagonist Valsartan (Diovan).
Also known as: Diovan
Drug pages: Acetylcholine · Nitroprusside · Angiotensin II · Norepinephrine · Phentolamine
Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test, muscle sympathetic nerve activity measurement; vasodilation with nitroglycerin followed by Angiotensin-II and Alpha Adrenergic blockade with infusions of Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine and Phentolamine (Regitine).
Also known as: Regitine
Drug pages: cyclo(Trp-Asp-Pro-Val-Leu) · Mitoquinone · Sapropterin
Catheter placement in femoral artery and femoral vein and muscle biopsy; Nuclear Magnetic Resonance (NMR) scanning and exercise bouts at baseline and following treatment with BQ-123 with or without oral mitochondria-targeted antioxidant (MitoQ) or oral BH4.
Change in Limb Blood Flow
Change in local limb blood flow as measured by ultrasound Doppler in units of milliliters per minute (mL/min) from baseline to up to 1 hour following study interventions
Time frame: Baseline and 1 hour
Change in Blood Pressure
Change in local limb blood pressure measured in millimeters of mercury (mmHg) from baseline to up to 1 hour following study interventions
Time frame: Baseline and 1 hour
Change in Maximum Exercise Capacity
Change in maximal exercise capacity - handgrip strength measured by dynamometer in units of kilograms from baseline to up to 1 hour following study interventions
Time frame: Baseline and 1 hour
Change in Peak Rate of Mitochondrial Adenosine Triphosphate (ATP) Synthesis
Change in muscle peak rate of mitochondrial ATP synthesis as measured by 31P-magnetic resonance spectroscopy (31P-MRS) from baseline up to 1 hour following study interventions
Time frame: Baseline and 1 hour
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Sep 2008, a primary completion of Aug 2030 and a completion of Aug 2030. It does not say whether these dates are actual or estimated.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Aug 2026 → Aug 2030 and completion Aug 2026 → Aug 2030.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: cyclo(Trp-Asp-Pro-Val-Leu)
Pulmonary Disease, Chronic Obstructive →