Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2020-06-30

Brief Summary

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Study of PAH Subjects with LTOT Use that have Demonstrated Improved Exercise Tolerance with the use of Inhaled Nitric Oxide

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Detailed Description

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Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Withdrawal Study of Pulmonary Arterial Hypertension(PAH) Subjects with LTOT Use that have Demonstrated Improved Exercise Tolerance with the use of Inhaled Nitric Oxide (INO)

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1: Placebo 99.999% Nitrogen

Randomized Withdrawal Treatment Period Week 1-8:

Placebo at a dose setting of 75 mcg/kg IBW/hr for up to 24 hr/day

Long Term Open Label Extension Period:

iNO at a dose setting of 75 mcg/kg IBW/hr for up to 24 hr/day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo at a dose setting of 75 mcg/kg IBW/hr

iNO

Intervention Type DRUG

iNO at a dose setting of 75 mcg/kg IBW/hr

Cohort 2: iNO 75 mcg/kg IBW/hr

Randomized Withdrawal Treatment Period Week 1-8:

iNO at a dose setting of 75 mcg/kg IBW/hr for up to 24 hr/day

Long Term Open Label Extension Period:

iNO at a dose setting of 75 mcg/kg IBW/hr for up to 24 hr/day

Group Type ACTIVE_COMPARATOR

iNO

Intervention Type DRUG

iNO at a dose setting of 75 mcg/kg IBW/hr

Interventions

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Placebo

Placebo at a dose setting of 75 mcg/kg IBW/hr

Intervention Type DRUG

iNO

iNO at a dose setting of 75 mcg/kg IBW/hr

Intervention Type DRUG

Other Intervention Names

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Placebo 99.999% Nitrogen Inhaled Nitric Oxide

Eligibility Criteria

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Inclusion Criteria

1. Signed Informed Consent Form prior to the initiation of any study mandated procedures or assessments
2. Subjects must be enrolled in the PULSE PAH-004 clinical trial and must have been on LTOT and on open-label treatment with iNO 75 mcg/kg IBW/hr for at least 4 months
3. Subjects must have achieved ≥ 30 meter improvement in 6MWD after 4, 8 or 12 months of open-label treatment with iNO 75 mcg/kg IBW/hr as compared to either their PULSE PAH-004 Week 2 end of Run-in OR End of Study (EOS)in PULSE-PAH-004.
4. Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day
5. Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) at randomization. All female subjects must use an effective method of birth control to avoid pregnancy.

Exclusion Criteria

1. Subjects with episodes of worsening of PAH in the last 30 days prior to PULSE PAH-007 Baseline/Randomization
2. Subjects that experience Pulmonary Rebound in PULSE-PAH-004
3. Change in dose or types of PAH specific therapies in the last 30 days prior to Baseline/Randomization
4. Subjects who require treatment with riociguat
5. Subjects who early discontinued drug/device usage due to withdrawal of consent or an adverse event requiring termination from treatment in PULSE PAH-004
6. Women who are pregnant
7. The concurrent use of the INOpulse device with a continuous airway pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP, or any other positive pressure device.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No