NCT03727451

A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis

A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis or Sarcoidosis on Long Term Oxygen Therapy Followed by an Optional Open-Label Long Term Extension Safety Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Bellerophon · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A phase 2b, open label study to assess the safety and efficacy of increasing doses of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis and sarcoidosis on long term oxygen therapy followed by a long term extension study

Detailed description

A phase 2b, open label study to assess the hemodynamic effects of increasing doses of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary hypertension associated with pulmonary fibrosis or sarcoidosis on long term oxygen therapy followed by an open label extension study

Conditions

• Pulmonary Hypertension
• Pulmonary Fibrosis
• Sarcoidosis, Pulmonary

Interventions

Type	Name	Description
COMBINATION_PRODUCT	iNO	inhaled nitric oxide

Timeline

• Start date: 2019-01-30
• Primary completion: 2021-09-07
• Completion: 2022-06-15
• First posted: 2018-11-01
• Last updated: 2022-08-10

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study