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

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ClinicalTrials.gov Identifier: NCT02436512
Recruitment Status : Withdrawn (Inability meet enrollment in study population.)
First Posted : May 6, 2015
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Geno LLC

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Inhaled Nitric Oxide Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


Arm Intervention/treatment
Experimental: Inhaled Nitric Oxide
Active Comparator: Nitric Oxide
Drug: 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
Other Names:
  • GeNOsyl(R) Delivery System
  • GeNOsyl(R) Acute DS




Primary Outcome Measures :
  1. Wean Success vs Wean Failure [ Time Frame: Visit 4 - Day 84 ]

    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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436512


Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Geno LLC
Investigators
Study Director: Cassie Newell, MAOM Geno LLC

Responsible Party: Geno LLC
ClinicalTrials.gov Identifier: NCT02436512     History of Changes
Other Study ID Numbers: P-2014-001
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents