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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02725372
Recruitment Status : Terminated (Trial stopped for futility)
First Posted : April 1, 2016
Results First Posted : January 25, 2023
Last Update Posted : February 21, 2023
Worldwide Clinical Trials
Information provided by (Responsible Party):
Bellerophon ( Bellerophon Pulse Technologies )

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)

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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

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

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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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 (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02725372

Hide Hide 109 study locations
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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
Innsbruck Medical University, University Hospital for Internal Medicine VI, Pneumology
Innsbruck, Tirol, Austria, 6020
AKH-Vienna, Medical University of Vienna
Wien, Austria, 1090
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
Fundación Abood Shaio
Bogotá, Bogotá D.C., Colombia
University Hospital centre Zagreb
Zagreb, Croatia, 10000
Vseobecna Fakultni Nemocnice v Praze (VFN)
Praha 2, Bohemia, Czechia, 128 02
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
"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
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
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
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, Netherlands, 1081 HV
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
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
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
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
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
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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

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Responsible Party: Bellerophon Pulse Technologies Identifier: NCT02725372    
Other Study ID Numbers: PULSE-PAH-004
First Posted: April 1, 2016    Key Record Dates
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
Inhaled Nitric Oxide
long term oxygen therapy
oxygen therapy
Additional relevant MeSH terms:
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Pulmonary Arterial 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
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents