NCT05747508

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

A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Clinical Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide (iNO) in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Bellerophon · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A Phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to assess the safety and efficacy of pulsed, inhaled nitric oxide in subjects with and without pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2)

Conditions

• Pulmonary Fibrosis
• Pulmonary Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-12-29
• Primary completion: 2019-11-22
• Completion: 2023-12-01
• First posted: 2023-02-28
• Last updated: 2023-02-28

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study