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

NCT01092559 | Completed Phase 2 Results

• 1 other identifier: P2010-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Diagnostic Techniques and Procedures

Outcome Measures

Primary Outcomes (2)

• 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 \[through discharge from Treatment Period\]

  through Day 30 Follow-up Period

• Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation

  through Treatment Period

Study Arms (1)

nitric oxide via GeNO Nitrosyl system

EXPERIMENTAL

Nitric Oxide via GeNO Nitrosyl system

Drug: Nitric Oxide generated by the GeNO nitrosyl delivery system

Interventions

Nitric Oxide generated by the GeNO nitrosyl delivery system DRUG

single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.

nitric oxide via GeNO Nitrosyl system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Geno LLC: lead

Study Sites (3)

Tufts

Boston, Massachusetts, 02111, United States

Location

University Hospital

Cleveland, Ohio, 44106, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Director of Clinical Development
• Organization: GeNO, LLC

matthew.rush@genollc.com

321-785-2613

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: March 25, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 4, 2013
• Results First Posted: June 4, 2013

Record last verified: 2013-04

Locations

US (3)