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Vasodilator

PH-Pulmonary Fibrosis for Pulmonary Hypertension

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

Study Summary

This study is evaluating whether inhaled nitric oxide may help improve lung function in patients with pulmonary fibrosis and sarcoidosis.

Eligible Conditions
  • Pulmonary Hypertension
  • Pulmonary Fibrosis
  • Sarcoidosis

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 6MWD from Baseline to 16 Weeks
Measurement of CO
Measurement of PCWP
+2 more
Secondary outcome measures
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
9%
All Cause Mortality
6%
Arterial Thromboembolic CVA/Stroke
5%
Venous Thromboembolic PE
3%
Arterial Thromboembolic Mesenteric Ischemia
2%
Arterial Thromboembolic Myocardial Infarction
2%
Upper GI Bleed
1%
Lower GI Bleed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lung Transplant With iNO
Lung Transplant With iEPO
Heart Transplant & LVAD Implantation With iNO
Heart Transplant & LVAD Implantation With iEPO

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

Find a Location

Who is running the clinical trial?

BellerophonLead Sponsor
7 Previous Clinical Trials
210 Total Patients Enrolled
Edward Parsley, DOStudy DirectorBellerophon Pulse Technologies
2 Previous Clinical Trials
336 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis
2019. "A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03727451.
~3 spots leftby Apr 2025
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