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

Pulmonary Arterial Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03602781
• Other study ID #: PULSE-PAH-007
• Status: Withdrawn
• Phase: Phase 3
• Start date: August 2018
• Est. completion date: June 2020

Study information

• Verified date: July 2018
• Source: Bellerophon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Placebo
Placebo at a dose setting of 75 mcg/kg IBW/hr
• iNO
iNO at a dose setting of 75 mcg/kg IBW/hr

Locations

Country	Name	City	State
Canada	Peter Lougheed Centre	Calgary	Alberta
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Bluhm Cardiovascular Institute, Clinical Trials Unit	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Bellerophon Pulse Technologies	Worldwide Clinical Trials

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical worsening during iNO withdrawal for up to 8 weeks	A clinical worsening event is defined as: Death (all-cause mortality); Atrial septostomy; Hospitalization due to worsening of PAH; Need to start additional specific PAH treatment; Decrease of >15% in 6 Minute Walk Distance from randomization into the study; Worsening of WHO Functional Class (e.g., from Class II to Class III or IV, OR Class III to Class IV)	8 weeks
Secondary	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.	A clinical worsening event is defined as: Death (all-cause mortality); Atrial septostomy; Hospitalization due to worsening of PAH; Need to start additional specific PAH treatment; Decrease of >15% in 6 Minute Walk Distance from randomization into the study; Worsening of WHO Functional Class (e.g., from Class II to Class III or IV, OR Class III to Class IV)	8 weeks