Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide (PILOT)

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: NCT01092559
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : June 4, 2013
Last Update Posted : June 4, 2013
Information provided by (Responsible Party):
Geno LLC

Brief Summary:
This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial hypertension (PAH). All participants will receive inhaled nitric oxide in oxygen or nitric oxide in air delivered by nasal cannula. Hemodynamics, clinical laboratory and clinical assessment data will be collected on all participants to evaluate safety.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Nitric Oxide generated by the GeNO nitrosyl delivery system Phase 2

Detailed Description:


Participants meeting eligibility criteria will receive open label nitric oxide at 80 ppm via a nasal cannula. Hemodynamic clinical laboratory and clinical assessment data will be collected at baseline, after 15 minutes of inhaled nitric oxide administration, post RHC procedure and at hospital discharge. Day 5 +/- 3 post RHC, telephone contact to assess general health status.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery System
Study Start Date : October 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: nitric oxide via GeNO Nitrosyl system
Nitric Oxide via GeNO Nitrosyl system
Drug: Nitric Oxide generated by the GeNO nitrosyl delivery system
single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.

Primary Outcome Measures :
  1. Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs. [ Time Frame: through Day 30 Follow-up Period ]

    Adverse Event Severity [through Day 30 Follow-Up Period]

    Unanticipated Device Effects: any system malfunction, damage or NO2 threshold monitor alarms [through discharge from Treatment Period]

    Laboratory Tests: Hematology (CBC with differential), Chemistry (glucose, BUN, creatinine, sodium, potassium, carbon dioxide, creatinine kinase), Activated Clotting Test or Prothrombin Time, arterial blood gas, and methemoglobin.

    [through discharge from Treatment Period]

    Vital Signs: pulse, blood pressure, respiratory rate [through discharge from Treatment Period]

  2. Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation [ Time Frame: through Treatment Period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have a confirmed diagnosis of PAH, WHO Group 1.
  • WHO Functional Class II or III equivalent, PAH.
  • Have been clinically stable with regard to signs and symptoms of PAH for at least 30 days prior to RHC.
  • May be receiving approved mono therapies or combination PAH therapies.
  • Females that are surgically sterile or post-menopausal. Females of chil-bearing potential must have negative pregnancy test and must be practicing adequate birth control.

Exclusion Criteria:

  • Have had a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin) for PAH added within (1) month of RHC.
  • Have any PAH medication except for anticoagulants discontinued within the week prior to RHC.
  • Have evidence of significant parenchymal lung disease as evidenced by pulmonary function tests within the last six months
  • CREST (calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, telangiectasia) syndrome
  • Have a history of uncontrolled sleep apnea within three months of RHC.
  • Have a history of hemodynamically significant left-sided heart disease
  • Have evidence of left-sided heart disease
  • Have any other disease that is associated with pulmonary hypertension (e.g. congenital systemic-to-pulmonary shunt, sickle cell anemia, schistosomiasis).
  • Documented uncontrolled systemic hypertension as evidenced by systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
  • Have used prescription appetite suppressants within 3 months prior to wean/transition.
  • Have chronic kidney disease stage IV or worse or the requirement for dialysis.
  • Be receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
  • Have had an atrial septostomy.
  • Have anemia (hemoglobin <10 g/dL), active infection or any other ongoing condition that would interfere with the interpretation of study assessments.
  • Have any serious or life-threatening disease other than conditions associated with PAH (e.g. malignancy requiring aggressive chemotherapy, renal dialysis, etc.).
  • Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial
  • Participant is pregnant or lactating
  • Significant, ongoing alcohol or drug abuse.

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): NCT01092559

United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, Ohio
University Hospital
Cleveland, Ohio, United States, 44106
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Geno LLC

Responsible Party: Geno LLC Identifier: NCT01092559     History of Changes
Other Study ID Numbers: P2010-001
First Posted: March 25, 2010    Key Record Dates
Results First Posted: June 4, 2013
Last Update Posted: June 4, 2013
Last Verified: April 2013

Keywords provided by Geno LLC:
Diagnostic Techniques and Procedures

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract 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