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Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide (EAGLE)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Inhaled Nitric Oxide
Sponsored by
Geno LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama
  • Allegheny General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inhaled Nitric Oxide

Arm Description

Active Comparator: Nitric Oxide

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 13, 2015
Last Updated
September 3, 2015
Sponsor
Geno LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02436512
Brief Title
Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide
Acronym
EAGLE
Official Title
A Phase 3 Open-label Multi-Center, Two-Part Single-arm Study to Evaluate the Acute Vasodilation Response of Inhaled Nitric Oxide as a Predictor of Successful Wean From Parental Prostacyclins in Subjects With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Inability meet enrollment in study population.
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geno LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Nitric Oxide
Arm Type
Experimental
Arm Description
Active Comparator: Nitric Oxide
Intervention Type
Drug
Intervention Name(s)
Inhaled Nitric Oxide
Other Intervention Name(s)
GeNOsyl(R) Delivery System, GeNOsyl(R) Acute DS
Intervention Description
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
Primary Outcome Measure Information:
Title
Wean Success vs Wean Failure
Description
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
Time Frame
Visit 4 - Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassie Newell, MAOM
Organizational Affiliation
Geno LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

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Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide

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