Back to resultsPilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide (PILOT)
Primary Purpose
Pulmonary Arterial Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitric Oxide generated by the GeNO nitrosyl delivery system
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Arterial Hypertension focused on measuring Diagnostic Techniques and Procedures
Eligibility 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.
Sites / Locations
- Tufts
- University Hospital
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nitric oxide via GeNO Nitrosyl system
Arm Description
Nitric Oxide via GeNO Nitrosyl system
Outcomes
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.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01092559
Brief Title
Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide
Acronym
PILOT
Official Title
An Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geno LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Diagnostic Techniques and Procedures
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nitric oxide via GeNO Nitrosyl system
Arm Type
Experimental
Arm Description
Nitric Oxide via GeNO Nitrosyl system
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide generated by the GeNO nitrosyl delivery system
Intervention Description
single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
Primary Outcome Measure Information:
Title
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.
Description
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]
Time Frame
through Day 30 Follow-up Period
Title
Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation
Time Frame
through Treatment Period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Tufts
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
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Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide
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