INOvation-1: Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH

• Sponsor: Bellerophon Pulse Technologies (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02725372
• Collaborator: Worldwide Clinical Trials (Other)
• Enrollment: 162
• Locations: 109
• Arms: 2
• Actual Duration (Months): 28
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: Inhaled Nitric Oxide 75 mcg/kg IBW/hr; Drug: Placebo	Phase 3

Detailed Description

Phase 3, placebo controlled, double-blind, randomized, clinical study to determine safety, tolerability and efficacy of pulsed inhaled nitric oxide (iNO) versus placebo as add-on therapy in subjects with pulmonary arterial hypertension (PAH) who remain symptomatic on approved PAH monotherapy or combination approved PAH therapy and long term oxygen therapy (LTOT). (Part 1 and Part 2)

Study Design

• Study Type: Interventional
• Actual Enrollment: 162 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects With PAH (Part 1 and Part 2)
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inhaled Nitric Oxide 75mcg/KgIBW/Hr Part 1: 15Mcg/kg IBW/hr during Run-in Period dose titrated to Inhaled Nitric Oxide / 75mcg/KgIBW/Hr upon randomization to treatment arm. Part 2: iNO 75 mcg/kg IBW/hr Open Label Treatment (Open Label Treatment - All Subjects)	Drug: Inhaled Nitric Oxide 75 mcg/kg IBW/hr; Inhaled Nitric Oxide 15mcg/Kg IBW/hr for two week run in period dose titrated to Inhaled Nitric Oxide 75 mcg/kg IBW/hr at randomizationTreatment Period (Week 3 to Week 18); Other Names: Inhaled Nitric Oxide iNO
Placebo Comparator: Placebo Part 1: Placebo dose setting 15mcg/kg IBW/hr Run In Period / Placebo dose setting 75 mcg/kg IBW/hr treatment period	Drug: Placebo; Part 1 Placebo arm: Inhaled Nitric Oxide 15mcg/Kg IBW/hrfor two week run in period dose titrated to Inhaled Nitric Oxide 75 mcg/kg IBW/hr at randomizationTreatment Period; Other Names: Inhaled Nitric Oxide iNO

Outcome Measures

Primary Outcome Measures

1. Six Minute Walk Distance (6MWD) - Change from baseline 6MWD at 18 Weeks [Change from baseline to 18 weeks]

   Change in 6MWD from baseline to 18 weeks

Secondary Outcome Measures

1. Time to Clinical Worsening (TTCW) [baseline to 18 weeks]

   1. TTCW, the time (in days) from start of treatment to first event (first day the event is noted), with iNO as compared to placebo, measured from baseline to 18 weeks . TTCW event is defined as any of the following: Death (all-cause mortality) Atrial septostomy Hospitalization due to worsening of PAH (adjudicated) Start of new specific PAH TX (endothelin receptor antagonists [ERAs], phosphodiesterase type-5 [PDE-5] inhibitors or prostanoids), an increase in the dose of an ERA or PDE-5, increase in the dose or frequency of an inhaled prostanoids, or an increase in the dose of an intravenous or subcutaneous prostanoids by >10%. Decrease of >15% from baseline or >30% compared with the last study related measurement in 6MWD should be confirmed by a repeat measurement performed at least 14 days later Worsening of WHO Functional Class (e.g., from Class II to Class III or IV, OR Class III to Class IV); and confirmed by a repeat assessment at least 14 days later

2. Change in World Health Organization (WHO) Functional Class [from baseline to 18 weeks]

   Change in World Health Organization (WHO) Functional Class from baseline to 18 weeks

Other Outcome Measures

1. Change in health-related quality of life using Short Form-36 (SF-36) version 2 health survey [from baseline to 18 weeks]

   Change in QOL SF36 from Baseline to 18 weeks

2. Change in Pulmonary Hemodynamics [from baseline to 18 weeks]

   Change in pulmonary hemodynamics (i.e., cardiac output [CO], cardiac index [CI], mean pulmonary artery pressure [mPAP], mean pulmonary capillary wedge pressure [mPCWP], systolic pulmonary artery pressure [sPAP], diastolic pulmonary artery pressure [dPAP], pulmonary vascular resistance [PVR], and oxygen saturation by pulse oximeter [SpO2], mixed venous O2, and right atrial pressure [RAP]), measured by right heart catheterization (RHC), with iNO as compared to placebo, from baseline to 18 weeks, in a subset of subjects (approximately 50), at selected sites

3. Change in Echocardiogram measurements [from baseline to 18 weeks]

   Change in echocardiogram measurements right ventricular function (including right ventricular fractional area change, systolic pulmonary artery pressure [sPAP], tricuspid annular motion/tricuspid annular plane systolic excursion, tricuspid annular systolic velocity, and Tei index) and left ventricular function (including left ventricular ejection fraction [LVEF], LV size, and improvement in LV early diastolic relaxation velocity), with iNO as compared to placebo, from baseline to 18 weeks, in a subset of subjects (approximately 50), at selected sites

4. Change in Prop BNP [from screening to 18 weeks]

   as compared to placebo from screening to 18 weeks

5. Change in Borg Dyspnea Scale [from baseline to 18 weeks]

   immediately following 6MWT with iNO as compared to Placebo from baseline, to 18weeks

6. Change in 6MWD [from baseline to 18weeks]

   as related to degree of drug adherence, with iNO as compared to placebo,

7. Unsatisfactory Clinical Response [from baseline to 18weeks]

   Number of subjects with unsatisfactory clinical response, with iNO as compared to placebo, from baseline to 18 weeks. Defined as WHO Functional Class III or IV symptoms with no improvement

8. Subjects undergoing heart-lung or lung transplant [from baseline to 18weeks]

   Number of subjects undergoing heart-lung or lung transplantation, number of subjects listed for transplantation, deaths while awaiting transplant, from baseline to 18 week

9. Medical Resource Utilization [from baseline to 18 weeks]

   Economic evaluation of the use as compared to placebo from baseline to 18weeks. Number of hospitalizations, Er visits and outpatient visits in the previous year as compared to study duration. Frequency duration and diagnosis will be recorded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments

2. A confirmed diagnosis of PAH Group 1 who have either idiopathic PAH (IPAH), heritable PAH, drug and toxin-induced PAH, associated PAH (APAH) with connective tissue disease (CTD), APAH with repaired simple congenital systemic to pulmonary shunt (i.e., atrial septal defect, ventricular septal defect and/or patent ductus arteriosus; complete repair at least 1 year prior to Screening), APAH with human immunodeficiency virus (HIV), or APAH with portal hypertension

3. Subjects receiving at least one PAH specific therapy (ERA or PDE-5 inhibitor, or inhaled, subcutaneous, or intravenous prostacyclin or a prostacyclin analog) with the same type of therapy for at least 3 months with stable dosing 4 weeks prior to Screening. (Subjects should be receiving optimal therapy according to the disease severity)

4. Subjects using oxygen therapy by nasal cannula for at least 4 weeks prior to Screening

5. PAH diagnosis confirmed by RHC within the previous 5 years, according to the following definitions:

• PVR ≥ 400 dynes.sec.cm-5 (5 Wood units)

• mPAP ≥ 25 mmHg

• PCWP or LVEDP ≤ 15 mmHg

• Subjects who otherwise meet all the inclusion criteria and none of the exclusion criteria but have not undergone a RHC within the previous 5 years may be considered eligible for the study if they undergo a RHC and then meet the pulmonary hemodynamics criterion

1. 6MWD ≥ 100 meters and ≤ 450 meters prior to randomization

2. WHO Functional Class II-IV. Subjects with WHO Functional Class IV should be treated with prostacyclin or a prostacyclin analog (subcutaneous or intravenous), plus at least one additional PAH specific therapy (ERA or PDE-5), if available to the subject and reimbursed by health insurance

3. Age between 18 and 85 years (inclusive)

4. Willingness to use INOpulse delivery device for at least 12 hours per day

5. Willingness to continue on study drug until the subject has completed Week 18 assessments

6. Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female subjects should take adequate precaution to avoid pregnancy.

Exclusion Criteria:

1. Subjects with known HIV infection who have a history within the past 3 months of any opportunistic pulmonary disease (e.g., tuberculosis, Pneumocystis carinii pneumonia, or other pneumonias) at the time of Screening 2. PAH associated with untreated thyroid disorders, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or splenectomy 3. Subjects with pulmonary conditions that may contribute to PAH including, but not limited to, chronic bronchiectasis, cystic fibrosis, or other pulmonary condition that the Investigator may deem to contribute to the severity of the disease or impair the delivery of iNO due to airway disease 4. Subjects receiving riociguat 5. Subjects receiving oral prostanoids as monotherapy 7. PAH associated with significant venous or capillary involvement, known or suspected pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis 8. Any subject with WHO PH Groups 2, 3, 4 or 5 9. Subjects with any of the following cardiac abnormalities:

1. Underlying cardiomyopathy or clinically significant aortic or mitral valve disease in the opinion of the investigator b. Left ventricular systolic dysfunction (LVSD), i.e., left ventricular ejection fraction (LVEF) < 40% or left ventricular shortening fraction (LVSF) < 22%, as determined by local reading c. Current symptomatic coronary artery disease, myocardial infarction within 1 year, or any coronary artery interventions within 6 months

1. Systemic hypertension defined as systolic blood pressure (SBP) > 160 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg persistent at Screening after a period of rest (treated or untreated) 11. Subjects with a history of deep vein thrombosis, pulmonary embolism/infarction or prothrombotic disorder must have had chronic thromboembolic pulmonary hypertension (CTEPH) excluded by ventilation/perfusion lung (V/Q) scan 12. Severe obstructive lung disease defined as both a forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 55% of predicted value 13. Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted; if TLC 60% to 70% predicted, a high resolution CT scan showing diffuse disease or more than mild patchy disease 14. Any subject who develops or has developed a PCWP > 20 mmHg during acute vasodilator testing (AVT) 15. Systemic hypotension defined as SBP < 90 mmHg persistent at Screening after a period of rest 16. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C 17. On dialysis 18. Acute or chronic physical impairment (other than dyspnea due to PAH) that would limit the ability to comply with study procedures or adherence to therapy (i.e., 6MWT), including carrying and wearing the pulsed delivery device per study protocol, or medical problem(s) likely to preclude completion of the study

2. Pregnant or breastfeeding females at Screening 20. Administered L-arginine within 1 month prior to Screening 21. Known concomitant life-threatening disease with a life expectancy less than 1 year 22. Atrial septostomy within 3 months preceding randomization

3. The concurrent use of the INOpulse device with a continuous positive airway pressure (CPAP), Bilevel positive airway presure BiPAP, or any other positive pressure device.

4. Use of investigational drugs or devices within 1 month prior to Screening (other than acute vasodilator testing with iNO) 25. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study 26. Any subject who has been enrolled in any previous clinical study with inhaled NO administered through pulse delivery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Pulmonary Specialists, Ltd	Phoenix	Arizona	United States	85012
2	University of Arizona Sarver Heart Center	Tucson	Arizona	United States	85724-5046
3	Cedars-Sinai Medical Center	Beverly Hills	California	United States	90211
4	UC San Diego / Pulmonary, Critical Care and Sleep Medicine Division	La Jolla	California	United States	92093
5	West Los Angeles VA Healthcare Center	Los Angeles	California	United States	90073
6	University of California, Davis Medical Center	Sacramento	California	United States	95817
7	University of Colorado Denver	Aurora	Colorado	United States	80045
8	Pulmonary Disease Specialists, PA	Kissimmee	Florida	United States	34741
9	Central Florida Pulmonary Group, PA	Orlando	Florida	United States	32803-5727
10	Cleveland Clinic Florida	Weston	Florida	United States	33331
11	Pulmonary and Critical Care of Atlanta	Atlanta	Georgia	United States	30342
12	Piedmont Healthcare Pulmonary and Critical Care Research	Austell	Georgia	United States	30106
13	Wellstar Medical Group - Pulmonary Medicine	Marietta	Georgia	United States	30060
14	Bluhm Cardiovascular Institute, Clinical Trials Unit	Chicago	Illinois	United States	60611
15	HeartCare Midwest	Peoria	Illinois	United States	61616
16	Kentuckiana Pulmonary Associates (KPA), Inc. - Louisville	Louisville	Kentucky	United States	40202-1332
17	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
18	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-5590
19	Albany Medical Center	Albany	New York	United States	12208
20	Montefiore Medical Center - Weiler Division	Bronx	New York	United States	10461
21	New York Presbyterian Brooklyn Methodist Hospital - Division of Pulmonary/Critical Care/Sleep	Brooklyn	New York	United States	11215
22	Winthrop University Hospital, Clinical Trials Center	Mineola	New York	United States	11501
23	NYU Medical Center, Division Pulmonary, Critical Care and Sleep Medicine	New York	New York	United States	10279
24	University of Cincinnati Medical Ctr, Dept of Internal Medicine / Pulmonary, Critical Care & Sleep Medicine	Cincinnati	Ohio	United States	45267-0564
25	Cleveland Clinic	Cleveland	Ohio	United States	44195
26	The Ohio State University	Columbus	Ohio	United States	43065
27	Legacy Medical Group - Pulmonary Clinic	Portland	Oregon	United States	97210
28	The Oregon Clinic, PC	Portland	Oregon	United States	97220
29	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
30	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania	United States	15212
31	Medical University of South Carolina	Charleston	South Carolina	United States	29425
32	MedTrial, LLC	Columbia	South Carolina	United States	29204
33	Sioux Falls Cardiovascular	Sioux Falls	South Dakota	United States	57108
34	University of Texas Southwestern Medical Center of Dallas	Dallas	Texas	United States	75390-8550
35	Pulmonary Associates of Richmond	Richmond	Virginia	United States	23229
36	University of Wisconsin	Madison	Wisconsin	United States	53792-1615
37	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
38	St Vincent's Public Hospital	Darlinghurst	New South Wales	Australia	2010
39	Nepean Hospital	Kingswood	New South Wales	Australia	2747
40	Macquarie University Hospital	Sydney	New South Wales	Australia	2109
41	Concord Repatriation General Hospital	Sydney	New South Wales	Australia	2139
42	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
43	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
44	Royal Hobart Hospital	Hobart	Tasmania	Australia	7000
45	Innsbruck Medical University, University Hospital for Internal Medicine VI, Pneumology	Innsbruck	Tirol	Austria	6020
46	AKH-Vienna, Medical University of Vienna	Wien		Austria	1090
47	Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg -	Leuven	Brabant	Belgium	3000
48	Hopital Erasme - Service de Cardiologie	Bruxelles		Belgium	1070
49	Faculty of Medicine / Peter Lougheed Center / Respiratory Research	Calgary	Alberta	Canada	T1Y 6J4
50	Lawson Clinical Research Services / London Health Sciences Centre - VH	London	Ontario	Canada	N6A 5W9
51	Toronto General Hospital, University Health Network	Toronto	Ontario	Canada	M5G 2C4
52	Fundación Abood Shaio	Bogotá	Bogotá D.C.	Colombia
53	University Hospital centre Zagreb	Zagreb		Croatia	10000
54	Vseobecna Fakultni Nemocnice v Praze (VFN)	Praha 2	Bohemia	Czechia	128 02
55	Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen - Hopital Charles Nicolle	Rouen	Normandy	France	76031
56	Centre Hospitalier Universitaire de Grenoble (CHU Grenoble) - Clinique de Pneumologie	Grenoble	Rhone	France	38043
57	Centre Hospitalier Universitaire de Saint Etienne	St Priest en Jarez	Rhone	France	42270
58	Hôpital Arnaud De Villeneuve - Service des Maladies Respiratoires	Montpellier		France	34295
59	CHU de Nice Hôpital Pasteur - Pavillon H - Service Pneumologie	Nice		France	06001
60	"Universitätsklinikum Freiburg - Medizinische Universitätsklinik	Freiburg	Baden-Württemberg	Germany	79106
61	Thoraxklinik am Universitätsklinikum Heidelberg-Zentrum für Pulmonale Hypertension	Heidelberg	Baden-Württemberg	Germany	69126
62	Waldburg-Zeil Kliniken - Fachkliniken Wangen Klinik für Pneumologie	Wangen	Baden-Württemberg	Germany	88239
63	Klinikum der Universität Regensburg - Klinik und Poliklinik für Innere Medizin II	Regensburg	Bayern	Germany	93053
64	Universitätsmedizin Greifswald Zentrum für innere Medizin Klinik und Poliklinik für Innere Medizin B	Greifswald	Mecklenburg-Vorpommern	Germany	17475
65	Medizinische Hochschule Hannover-Abteilung für Pneumologie	Hannover	Niedersachsen	Germany	30625
66	Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Medizinische Klinik und Poliklinik I	Dresden	Sachsen	Germany	01307
67	Universitätsklinikum Leipzig-Dept. für Innere MedizinAbteilung für Pneumologie	Leipzig	Sachsen	Germany	04103
68	Helios Klinikum Erfurt	Erfurt	Thüringen	Germany	99089
69	Unfallkrankenhaus Berlin-Klinik für Innere Medizin/Kardiologie	Berlin		Germany	12683
70	Barzilai University Medical Center	Ashqelon		Israel	7830604
71	Soroka Medical Center	Beer Sheba		Israel	84101
72	Carmel Medical Center	Haifa		Israel	3436212
73	The Edith Wolfson Medical Center	Holon		Israel	58100
74	Hadassah University Medical Center	Jerusalem		Israel
75	Meir Medical Center - Pulmonology Dept.	Kfar Saba		Israel	4428164
76	Rabin Medical Center	Petaẖ Tiqwa		Israel	49100
77	Sheba Medical Center	Ramat Gan		Israel	5265601
78	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo	BG	Italy	24129
79	Azienda Ospedaliera San Gerardo - Monza	Monza	MI	Italy	20900
80	Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione	Palermo	PA	Italy	90127
81	A.O.U. Policlinico Umberto I- Università La Sapienza	Roma	RM	Italy	00161
82	Vrije Universiteit Medisch Centrum (VUMC)	Amsterdam		Netherlands	1081 HV
83	Hospital Garcia de Orta	Almada	Lisbon	Portugal	2801-951
84	Universidade de Coimbra - Hospitais da Universidade de Coimbra (H.U.C)	Coimbra	Mondego	Portugal	3049
85	Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria	Lisbon		Portugal	1649-035
86	Clinical Center of Serbia Department of Cardiology and Polyclinic	Belgrade		Serbia	11000
87	Clinical Center of Serbia, Polyclinic, Pulomology Department	Belgrade		Serbia	11000
88	Clinical-Hospital Center Zemun	Belgrade		Serbia	11070
89	Clinical Hospital Center Bezanijska Kosa	Belgrade		Serbia	11080
90	Clinical Center of Nis, Clinic for Cardiovascular Diseases	Nis		Serbia	18000
91	Complejo Hospitalario Universitario de Santiago de Compostela	Santiago de Compostela	A Coruña	Spain	15706
92	Hospital Universitario de Gran Canaria Dr. Negrin	Las Palmas de Gran Canaria	Canarias	Spain	35020
93	Hospital Universitario Marques de Valdecilla (HUMV)	Santander	Cantabria	Spain	39008
94	Hospital Virgen de la Salud (HVS)	Toledo	Castile - La Mancha	Spain	45004
95	Hospital Universitario Puerta de Hierro - Madrid	Majadahonda	Madrid	Spain	28222
96	Hospital Universitario Son Espases	Palma de Mallorca	Mallorca	Spain	7120
97	Hospital Universitario Vall d'hebron	Barcelona		Spain	8035
98	Hospital Clinic de Barcelona	Barcelona		Spain	8036
99	Hospital Universitario de Valladolid	Valladolid		Spain	47003
100	Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery of Dnipropetrovsk Regional Council, Department of Cardiology	Dnepropetrovsk		Ukraine	49094
101	Municipal Institution of health care "Kharkiv City Clinical Hospital №13", Pulmonology Department №1	Kharkiv		Ukraine	61035
102	Government Institution "L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine", Cardiopulmonology Department	Kharkiv		Ukraine	61039
103	National institute of phthisiology and pulmonology	Kyiv		Ukraine	03680
104	National Scientific Centre "M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, MAS OF UKRAINE"	Kyiv		Ukraine	03680
105	Lviv Regional Clinical Hospital, Department of Intesive Care #2	Lviv		Ukraine	79010
106	Freeman Hospital	Newcastle Upon Tyne	Newcastle	United Kingdom	NE7 7DN
107	Golden Jubilee National Hospital	Clydebank	West Dunbartonshire	United Kingdom	G81 4DY
108	Royal Free Hospital	London		United Kingdom	NW3 3QG
109	Royal Brompton Hospital	London		United Kingdom	SW3 6NP

Sponsors and Collaborators

• Bellerophon Pulse Technologies
• Worldwide Clinical Trials

Investigators

• Study Director: Deborah Quinn, MD, Bellerophon Therapuetics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bellerophon Pulse Technologies
• ClinicalTrials.gov Identifier: NCT02725372
• Other Study ID Numbers: PULSE-PAH-004
• First Posted: Apr 1, 2016
• Last Update Posted: Aug 6, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Bellerophon Pulse Technologies: Pulmonary Arterial Hypertension; PAH; Inhaled Nitric Oxide; iNO; long term oxygen therapy; oxygen therapy
• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Hypertension; Nitric Oxide

Study Results

No Results Posted as of Aug 6, 2019