Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide

NCT02436512 | Withdrawn Phase 3 DMC

• 1 other identifier: P-2014-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Wean Success vs Wean Failure

  To evaluate the number of subjects that achieve Wean Success that are Vasoreactivity Response (VR) positive (+) versus VR negative (-)and the number of subjects that are Wean Failures that are VR(+) versus VR(-). Wean-Success: * No parenteral PGI therapy at 3 months post-wean completion; and * Clinical stability, where clinical stability is defined as: * A decrease in 6MWT distance less than 10% from pre-wean; and * NT-proBNP increase \<15% from pre-wean; and * WHO Functional Class \<III Wean-Failure: * Subjects that wean successfully but do not meet all clinical stability components of the Wean-Success definition above; or * Failure to wean within the 3 month Transition Period; or * Re-initiation of parental PGI during the 3 month post-wean or subject does not meet the definition of clinical stability at 3 month post-wean; or * Death or hospitalization due to progression of disease; or * Atrial septostomy; or * Heart and/or lung transplantation

  Visit 4 - Day 84

Study Arms (1)

Inhaled Nitric Oxide

EXPERIMENTAL

Active Comparator: Nitric Oxide

Drug: Inhaled Nitric Oxide

Interventions

Inhaled Nitric Oxide 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

Also known as: GeNOsyl(R) Delivery System, GeNOsyl(R) Acute DS

Inhaled Nitric Oxide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Geno LLC: lead

Study Sites (2)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cassie Newell, MAOM

  Geno LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: May 6, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 7, 2015

Record last verified: 2015-06

Locations

US (2)