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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geno LLC
ClinicalTrials.gov Identifier:
NCT01092559
First received: February 16, 2010
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Pulmonary Arterial Hypertension
Drug: Nitric Oxide generated by the GeNO nitrosyl delivery system
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery System

Resource links provided by NLM:


Further study details as provided by Geno LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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]


  • Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation [ Time Frame: through Treatment Period ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

TREATMENT/FOLLOW-UP:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092559

Locations
United States, Massachusetts
Tufts
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
  More Information

No publications provided

Responsible Party: Geno LLC
ClinicalTrials.gov Identifier: NCT01092559     History of Changes
Other Study ID Numbers: P2010-001
Study First Received: February 16, 2010
Results First Received: April 18, 2013
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Geno LLC:
Diagnostic Techniques and Procedures

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on September 22, 2014