A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis
NCT03727451 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2022-08-10
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
Conditions
- Pulmonary Hypertension
- Pulmonary Fibrosis
- Sarcoidosis, Pulmonary
Interventions
- COMBINATION_PRODUCT
-
iNO
inhaled nitric oxide
Sponsors & Collaborators
-
Bellerophon
lead INDUSTRY
Principal Investigators
-
Edward Parsley, DO · Bellerophon Pulse Technologies
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-30
- Primary Completion
- 2021-09-07
- Completion
- 2022-06-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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