Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide

NCT ID: NCT02436512

Last Updated: 2015-09-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-08-31

Brief Summary

The EAGLE study is a Phase 3, open-label, multi-center, two-part, single-arm study of GeNOsyl(R) delivery system(s) to evaluate if inhaled nitric oxide-induced vasodilation predicts successful wean from parenteral prostacyclin (PGI) in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) undergoing a medically necessary right heart catheterization (RHC). All subjects enrolled in the study will undergo an attempt to wean from parenteral PGI per standard of care.

Detailed Description

This study will be divided into 2 parts: a Pilot Phase followed by Pivotal Phase.

• The Pilot Phase will enroll up to 20 subjects. The information derived from the Pilot Phase will evaluate safety, and assess the vasoreactivity test response rate.
• Approximately 150 subjects will be enrolled in the Pivotal Phase of the study, to gather further data on weaned successes from parenteral PGI. The Investigator and study staff involved with the wean and patient management will be blinded in this phase of the study to the vasoreactivity results.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Inhaled Nitric Oxide

Active Comparator: Nitric Oxide

Group Type: EXPERIMENTAL

Inhaled Nitric Oxide

Intervention Type: DRUG

The investigational product is inhaled nitric oxide delivered via nasal cannula or venturi mask with the GeNOsylTM Delivery System or GeNOsylTM Acute DS, during RHC as follows:

• (Dose 1): 5 ppm inhaled nitric oxide for 15 minutes
• (Dose 2): 40 ppm inhaled nitric oxide for 15 minutes

Interventions

Inhaled Nitric Oxide

The investigational product is inhaled nitric oxide delivered via nasal cannula or venturi mask with the GeNOsylTM Delivery System or GeNOsylTM Acute DS, during RHC as follows:

• (Dose 1): 5 ppm inhaled nitric oxide for 15 minutes
• (Dose 2): 40 ppm inhaled nitric oxide for 15 minutes

Intervention Type: DRUG

Other Intervention Names

GeNOsyl(R) Delivery System; GeNOsyl(R) Acute DS

Eligibility Criteria

Inclusion Criteria

• The subject or subject's legally authorized representative signs and dates an Institutional Review Board (IRB) approved informed consent form prior to the initiation of any study-related activities.
• The subject has been diagnosed with PAH (WHO Group 1) and is WHO Functional Class I or II at Screening.
• The subject has documented continuous PGI use for ≥ 1 year from Screening, without a significant interruption (i.e., ≤ 2 day interruption) and without a failed complete wean attempt.
• The subject is a candidate for weaning off parenteral PGI therapy (per Investigator judgment and standard of care).

Exclusion Criteria

• The subject has a hypersensitivity or allergy to ingredients of inhaled nitric oxide or other clinically significant allergies (clinical significance per Investigator judgment).
• The subject has a PCWP or left ventricular end diastolic pressure (LVEDP) ≥15 mmHg at Baseline.
• The subject has participated in an investigational product or device study within the 30 days prior to Screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geno LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cassie Newell, MAOM

Role: STUDY_DIRECTOR

Geno LLC

Locations

University of Alabama

Birmingham, Alabama, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

P-2014-001

Identifier Type: -

Identifier Source: org_study_id