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A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

NCT05747508 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2023-02-28

No results posted yet for this study

Summary

A randomized, double-blind, placebo-controlled dose escalation study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis on long term oxygen therapy.

Conditions

Interventions

COMBINATION_PRODUCT

INOpulse®

Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula

COMBINATION_PRODUCT

Placebo

Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula

COMBINATION_PRODUCT

Long Term Follow Up

Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula

Sponsors & Collaborators

  • Bellerophon

    lead INDUSTRY

Principal Investigators

  • Ashika Ahmed, MD · Bellerophon Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-29
Primary Completion
2019-11-22
Completion
2023-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05747508 on ClinicalTrials.gov