Clinical trial NCT03602781: Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH
Inhaled Nitric Oxide
iNO
Long Term Oxygen Therapy
Oxygen therapy
Lead sponsor: Bellerophon
Sponsor class: INDUSTRY
Collaborators: name: Worldwide Clinical Trials
First posted: 2018-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Time to clinical worsening during iNO withdrawal for up to 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Difference in clinical worsening events that occur during iNO withdrawal for up to 8 weeks between those treated with iNO ≥ 10 months prior to the start of withdrawal of iNO vs. those treated < 10 months prior to initiation of withdrawal to iNO.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Bluhm Cardiovascular Institute, Clinical Trials Unit
state: Illinois
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
Study officials:
affiliation: Bellerophon Therapeutics
name: Ashika Ahmed, MD
role: STUDY_DIRECTOR
References: