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A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension

NCT03267108 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2023-07-27

No results posted yet for this study

Summary

A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD

Conditions

Interventions

COMBINATION_PRODUCT

INOpulse®

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

COMBINATION_PRODUCT

Placebo

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

COMBINATION_PRODUCT

Open Label Extension

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

Sponsors & Collaborators

  • Bellerophon Pulse Technologies

    lead INDUSTRY

Principal Investigators

  • Ashika Ahmed · Bellerophon Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2023-06-09
Completion
2023-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Canada

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 NCT03267108 on ClinicalTrials.gov