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Vasodilator

PH-Pulmonary Fibrosis for Pulmonary Fibrosis

Phase 2

Waitlist Available

Research Sponsored by Bellerophon

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment where patients breathe in short bursts of nitric oxide gas. It is aimed at people with lung diseases like pulmonary fibrosis or sarcoidosis who need long-term oxygen therapy. The treatment helps improve blood flow in the lungs, making it easier for these patients to breathe.

Eligible Conditions

Pulmonary Fibrosis
Pulmonary Sarcoidosis
Pulmonary Hypertension
Sarcoidosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 6MWD from Baseline to 16 Weeks

Measurement of CO

Measurement of PCWP

+2 more

Secondary study objectives

Distance Saturation Product (DSP)

Dyspnea

Incidence and Severity of Treatment Emergent Adverse Events

+4 more

Side effects data

From 2021 Phase 4 trial • 519 Patients • NCT03081052

28%

Venous Thromboemolic DVT

13%

Venous Thromboembolic Other

11%

New Onset Atrial Fibrillation

All Cause Mortality

Arterial Thromboembolic CVA/Stroke

Venous Thromboembolic PE

Arterial Thromboembolic Mesenteric Ischemia

Arterial Thromboembolic Myocardial Infarction

Upper GI Bleed

Lower GI Bleed

100%

80%

60%

40%

20%

Study treatment Arm

Lung Transplant With iNO

Lung Transplant With iEPO

Heart Transplant & LVAD Implantation With iNO

Heart Transplant & LVAD Implantation With iEPO

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PH-SarcoidosisExperimental Treatment1 Intervention

Part 1: 1st 4 subjects will be treated with iNO 30, 45, 75 mcg/kg IBW/hr 2nd 4 subjects will be treated with iNO 45, 75, 125 mcg/kg IBW/hr Part 2: Optional Open label long term extension at the optimal dose as identified in Part 1

Group II: PH-Pulmonary FibrosisExperimental Treatment1 Intervention

Part 1: 1st 4 subjects will be treated with iNO 30, 45, 75 mcg/kg IBW/hr 2nd 4 subjects will be treated with iNO 45, 75, 125 mcg/kg IBW/hr Part 2: Optional open label long term extension at the optimal dose as identified in Part 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

iNO

2011

Completed Phase 4

~1370

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