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

• ClinicalTrials.gov Identifier: NCT02725372
• Recruitment Status: Terminated
• First Posted: April 1, 2016
• Results First Posted: January 25, 2023
• Last Update Posted: February 21, 2023
• Sponsor: Bellerophon Pulse Technologies
• Collaborator: Worldwide Clinical Trials
• Information provided by (Responsible Party): Bellerophon ( Bellerophon Pulse Technologies )

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 (Clinical Trial)
• Actual Enrollment: 207 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: April 2016
• Actual Primary Completion Date: August 2018
• Actual Study Completion Date: August 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. Change in 6-minute Walk Distance (6MWD) From Baseline (Randomization) to End of Treatment Period (Week 18) [ Time Frame: Change in 6MWD from Week 2 (2 weeks after randomization and run-in period) to Week 18 (end of blinded treatment period) ]
   The 6-minute walk distance test (6MWD) is a non-encouraged test performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. All patients were required to complete two walks while on chronic oxygen therapy given at a standard rate during the test and throughout the study while using the investigational product (INOpulse device with nitric oxide or matching placebo). The average of two walks at Week 2 visit (2 weeks after Run-In) was used as the Baseline 6MWD.

Secondary Outcome Measures :

1. Time (in Days) to First Clinical Worsening Event (TTCW) [ Time Frame: From Randomization to Week 18 (End of blinded treatment period) ]
   Clinical worsening was assessed continuously from Randomization to Week 18 (End of blinded treatment period). Clinical worsening events were defined as death (all causes), atrial septostomy, hospitalization due to worsening of pulmonary arterial hypertension (PAH), initiation of new pulmonary arterial hypertension treatment including endothelin receptor antagonists [ERAs], phosphodiesterase type-5 [PDE-5] inhibitors or prostanoids, an increase in existing treatment of 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%, a decrease of >15% from baseline or >30% compared with the last study related measurement in 6MWD or worsening of WHO Functional Class (e.g., from Class II to Class III or IV, OR Class III to Class IV). All worsening events were entered by the study sites into the eCRF.
2. Number of Participants With an Improvement in World Health Organization Functional Class (WHO FC) Baseline (Randomization) to End of Treatment Period (Week 18) [ Time Frame: From Randomization to Week 18 (End of blinded treatment period) ]
   WHO FC (where Class I is defined as "No limitations in daily physical activities. No symptoms of dyspnea and with routine exertion" and Class IV is defined as "Inability to perform even minimal activities. Signs and symptoms of right heart failure may be present. Dyspnea present at rest") for PAH was taken at randomization (Week 0) for all participants and was assessed after blinded treatment (Week 18). The number of participants that had an improvement (lower functional class) as compared to baseline were measured.

Other Outcome Measures:

1. Change in Plasma N-Terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Screening to End of Treatment Period (Week 18) [ Time Frame: From Screening (28 days prior to baseline/randomization) to end of Blinded Treatment Period (Week 18) ]
   Plasma NT-proBNP concentration is a useful biomarker for the severity of PAH as it is associated with changes in right heart morphology and function. NT-proBNP sample collection occurred at Screening visit (prior to starting study drug at Randomization) and after 16 weeks of blinded treatment therapy (Week 18). The change in NT-proBNP between Screening (28 days prior to baseline/randomization) and the end of blinded treatment period (Week 18) is reported.
2. Change in Borg Dyspnea Scale Immediately Following 6-minute Walk Test (6MWT) From Baseline (Randomization) to End of Treatment Period (Week 18) [ Time Frame: From Randomization to Week 18 (End of blinded treatment period) ]
   The Borg dyspneas score is a self-rating scale to evaluate the severity of dyspnea (from 0 "no shortness of breath at all" to 10 "very, very severe / maximal") shortness of breath, where high score on the scale signifies a worse score. The self assessment was collected from each participant immediately after each 6-minute walk test throughout the blinded treatment period. The change in Borg dyspnea Score at the end of the blinded treatment period (Week 18) compared to baseline (randomization) (Week 0) is reported.
3. Number of Participants With an Unsatisfactory Clinical Response From Baseline (Randomization) to End of Treatment Period (Week 18) [ Time Frame: From Randomization to Week 18 (End of blinded treatment period) ]
   Unsatisfactory Clinical Response was defined as the number of participants with WHO Functional Class III (defined as moderate dyspnea with routine activities and activities of daily living. No symptoms at rest.) or Class IV (defined as inability to perform even minimal activities. Signs and symptoms of right heart failure may be present. Dyspnea present at rest) with no improvement in 6-minute walk distance (6MWD) from baseline to end of blinded treatment period (Week 18).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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
6. 6MWD ≥ 100 meters and ≤ 450 meters prior to randomization
7. 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
8. Age between 18 and 85 years (inclusive)
9. Willingness to use INOpulse delivery device for at least 12 hours per day
10. Willingness to continue on study drug until the subject has completed Week 18 assessments
11. 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:

a. 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 10. 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 19. 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 23. 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.

24. 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

United States, Arizona

Arizona Pulmonary Specialists, Ltd

Phoenix, Arizona, United States, 85012

University of Arizona Sarver Heart Center

Tucson, Arizona, United States, 85724-5046

United States, California

Cedars-Sinai Medical Center

Beverly Hills, California, United States, 90211

UC San Diego / Pulmonary, Critical Care and Sleep Medicine Division

La Jolla, California, United States, 92093

West Los Angeles VA Healthcare Center

Los Angeles, California, United States, 90073

University of California, Davis Medical Center

Sacramento, California, United States, 95817

United States, Colorado

University of Colorado Denver

Aurora, Colorado, United States, 80045

United States, Florida

Pulmonary Disease Specialists, PA

Kissimmee, Florida, United States, 34741

Central Florida Pulmonary Group, PA

Orlando, Florida, United States, 32803-5727

Cleveland Clinic Florida

Weston, Florida, United States, 33331

United States, Georgia

Pulmonary and Critical Care of Atlanta

Atlanta, Georgia, United States, 30342

Piedmont Healthcare Pulmonary and Critical Care Research

Austell, Georgia, United States, 30106

Wellstar Medical Group - Pulmonary Medicine

Marietta, Georgia, United States, 30060

United States, Illinois

Bluhm Cardiovascular Institute, Clinical Trials Unit

Chicago, Illinois, United States, 60611

HeartCare Midwest

Peoria, Illinois, United States, 61616

United States, Kentucky

Kentuckiana Pulmonary Associates (KPA), Inc. - Louisville

Louisville, Kentucky, United States, 40202-1332

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198-5590

United States, New York

Albany Medical Center

Albany, New York, United States, 12208

Montefiore Medical Center - Weiler Division

Bronx, New York, United States, 10461

New York Presbyterian Brooklyn Methodist Hospital - Division of Pulmonary/Critical Care/Sleep

Brooklyn, New York, United States, 11215

Winthrop University Hospital, Clinical Trials Center

Mineola, New York, United States, 11501

NYU Medical Center, Division Pulmonary, Critical Care and Sleep Medicine

New York, New York, United States, 10279

United States, Ohio

University of Cincinnati Medical Ctr, Dept of Internal Medicine / Pulmonary, Critical Care & Sleep Medicine

Cincinnati, Ohio, United States, 45267-0564

Cleveland Clinic

Cleveland, Ohio, United States, 44195

The Ohio State University

Columbus, Ohio, United States, 43065

United States, Oregon

Legacy Medical Group - Pulmonary Clinic

Portland, Oregon, United States, 97210

The Oregon Clinic, PC

Portland, Oregon, United States, 97220

United States, Pennsylvania

Temple University Hospital

Philadelphia, Pennsylvania, United States, 19140

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, United States, 15212

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

MedTrial, LLC

Columbia, South Carolina, United States, 29204

United States, South Dakota

Sioux Falls Cardiovascular

Sioux Falls, South Dakota, United States, 57108

United States, Texas

University of Texas Southwestern Medical Center of Dallas

Dallas, Texas, United States, 75390-8550

United States, Virginia

Pulmonary Associates of Richmond

Richmond, Virginia, United States, 23229

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53792-1615

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Australia, New South Wales

St Vincent's Public Hospital

Darlinghurst, New South Wales, Australia, 2010

Nepean Hospital

Kingswood, New South Wales, Australia, 2747

Macquarie University Hospital

Sydney, New South Wales, Australia, 2109

Concord Repatriation General Hospital

Sydney, New South Wales, Australia, 2139

Australia, Queensland

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Australia, South Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Australia, Tasmania

Royal Hobart Hospital

Hobart, Tasmania, Australia, 7000

Austria

Innsbruck Medical University, University Hospital for Internal Medicine VI, Pneumology

Innsbruck, Tirol, Austria, 6020

AKH-Vienna, Medical University of Vienna

Wien, Austria, 1090

Belgium

Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg -

Leuven, Brabant, Belgium, 3000

Hopital Erasme - Service de Cardiologie

Bruxelles, Belgium, 1070

Canada, Alberta

Faculty of Medicine / Peter Lougheed Center / Respiratory Research

Calgary, Alberta, Canada, T1Y 6J4

Canada, Ontario

Lawson Clinical Research Services / London Health Sciences Centre - VH

London, Ontario, Canada, N6A 5W9

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada, M5G 2C4

Colombia

Fundación Abood Shaio

Bogotá, Bogotá D.C., Colombia

Croatia

University Hospital centre Zagreb

Zagreb, Croatia, 10000

Czechia

Vseobecna Fakultni Nemocnice v Praze (VFN)

Praha 2, Bohemia, Czechia, 128 02

France

Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen - Hopital Charles Nicolle

Rouen, Normandy, France, 76031

Centre Hospitalier Universitaire de Grenoble (CHU Grenoble) - Clinique de Pneumologie

Grenoble, Rhone, France, 38043

Centre Hospitalier Universitaire de Saint Etienne

St Priest en Jarez, Rhone, France, 42270

Hôpital Arnaud De Villeneuve - Service des Maladies Respiratoires

Montpellier, France, 34295

CHU de Nice Hôpital Pasteur - Pavillon H - Service Pneumologie

Nice, France, 06001

Germany

"Universitätsklinikum Freiburg - Medizinische Universitätsklinik

Freiburg, Baden-Württemberg, Germany, 79106

Thoraxklinik am Universitätsklinikum Heidelberg-Zentrum für Pulmonale Hypertension

Heidelberg, Baden-Württemberg, Germany, 69126

Waldburg-Zeil Kliniken - Fachkliniken Wangen Klinik für Pneumologie

Wangen, Baden-Württemberg, Germany, 88239

Klinikum der Universität Regensburg - Klinik und Poliklinik für Innere Medizin II

Regensburg, Bayern, Germany, 93053

Universitätsmedizin Greifswald Zentrum für innere Medizin Klinik und Poliklinik für Innere Medizin B

Greifswald, Mecklenburg-Vorpommern, Germany, 17475

Medizinische Hochschule Hannover-Abteilung für Pneumologie

Hannover, Niedersachsen, Germany, 30625

Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Medizinische Klinik und Poliklinik I

Dresden, Sachsen, Germany, 01307

Universitätsklinikum Leipzig-Dept. für Innere MedizinAbteilung für Pneumologie

Leipzig, Sachsen, Germany, 04103

Helios Klinikum Erfurt

Erfurt, Thüringen, Germany, 99089

Unfallkrankenhaus Berlin-Klinik für Innere Medizin/Kardiologie

Berlin, Germany, 12683

Israel

Barzilai University Medical Center

Ashqelon, Israel, 7830604

Soroka Medical Center

Beer Sheba, Israel, 84101

Carmel Medical Center

Haifa, Israel, 3436212

The Edith Wolfson Medical Center

Holon, Israel, 58100

Hadassah University Medical Center

Jerusalem, Israel

Meir Medical Center - Pulmonology Dept.

Kfar Saba, Israel, 4428164

Rabin Medical Center

Petaẖ Tiqwa, Israel, 49100

Sheba Medical Center

Ramat Gan, Israel, 5265601

Italy

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, BG, Italy, 24129

Azienda Ospedaliera San Gerardo - Monza

Monza, MI, Italy, 20900

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

Palermo, PA, Italy, 90127

A.O.U. Policlinico Umberto I- Università La Sapienza

Roma, RM, Italy, 00161

Netherlands

Vrije Universiteit Medisch Centrum (VUMC)

Amsterdam, Netherlands, 1081 HV

Portugal

Hospital Garcia de Orta

Almada, Lisbon, Portugal, 2801-951

Universidade de Coimbra - Hospitais da Universidade de Coimbra (H.U.C)

Coimbra, Mondego, Portugal, 3049

Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria

Lisbon, Portugal, 1649-035

Serbia

Clinical Center of Serbia Department of Cardiology and Polyclinic

Belgrade, Serbia, 11000

Clinical Center of Serbia, Polyclinic, Pulomology Department

Belgrade, Serbia, 11000

Clinical-Hospital Center Zemun

Belgrade, Serbia, 11070

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia, 11080

Clinical Center of Nis, Clinic for Cardiovascular Diseases

Nis, Serbia, 18000

Spain

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain, 15706

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, Canarias, Spain, 35020

Hospital Universitario Marques de Valdecilla (HUMV)

Santander, Cantabria, Spain, 39008

Hospital Virgen de la Salud (HVS)

Toledo, Castile - La Mancha, Spain, 45004

Hospital Universitario Puerta de Hierro - Madrid

Majadahonda, Madrid, Spain, 28222

Hospital Universitario Son Espases

Palma de Mallorca, Mallorca, Spain, 7120

Hospital Universitario Vall d'hebron

Barcelona, Spain, 8035

Hospital Clinic de Barcelona

Barcelona, Spain, 8036

Hospital Universitario de Valladolid

Valladolid, Spain, 47003

Ukraine

Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery of Dnipropetrovsk Regional Council, Department of Cardiology

Dnepropetrovsk, Ukraine, 49094

Municipal Institution of health care "Kharkiv City Clinical Hospital №13", Pulmonology Department №1

Kharkiv, Ukraine, 61035

Government Institution "L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine", Cardiopulmonology Department

Kharkiv, Ukraine, 61039

National institute of phthisiology and pulmonology

Kyiv, Ukraine, 03680

National Scientific Centre "M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, MAS OF UKRAINE"

Kyiv, Ukraine, 03680

Lviv Regional Clinical Hospital, Department of Intesive Care #2

Lviv, Ukraine, 79010

United Kingdom

Freeman Hospital

Newcastle Upon Tyne, Newcastle, United Kingdom, NE7 7DN

Golden Jubilee National Hospital

Clydebank, West Dunbartonshire, United Kingdom, G81 4DY

Royal Free Hospital

London, United Kingdom, NW3 3QG

Royal Brompton Hospital

London, United Kingdom, SW3 6NP

Sponsors and Collaborators

Bellerophon Pulse Technologies

Worldwide Clinical Trials

Investigators

• Study Director: Ashika Ahmed, MD; Bellerophon Therapeutics

  Study Documents (Full-Text)

Documents provided by Bellerophon ( Bellerophon Pulse Technologies ):

Study Protocol  [PDF] June 7, 2017

Statistical Analysis Plan  [PDF] December 29, 2017

More Information

• Responsible Party: Bellerophon Pulse Technologies
• ClinicalTrials.gov Identifier: NCT02725372
• Other Study ID Numbers: PULSE-PAH-004
• First Posted: April 1, 2016
• Results First Posted: January 25, 2023
• Last Update Posted: February 21, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Bellerophon ( 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; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Hypertension, Pulmonary; Lung Diseases; Nitric Oxide; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Free Radical Scavengers; Antioxidants; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Endothelium-Dependent Relaxing Factors; Vasodilator Agents; Gasotransmitters; Protective Agents