Trials / Terminated
TerminatedNCT03267108
A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension
A Randomized, Double-Blind, Placebo-Controlled Dose Escalation and Verification Clinical Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide (iNO) in Subjects at Risk of Pulmonary Hypertension Associated With Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2) - REBUILD
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 145 (actual)
- Sponsor
- Bellerophon Pulse Technologies · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Detailed description
This is a Phase 3, randomized, double-blind, placebo-controlled dose escalation and verification clinical 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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-12-14
- Primary completion
- 2023-06-09
- Completion
- 2023-06-30
- First posted
- 2017-08-30
- Last updated
- 2023-07-27
Locations
64 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03267108. Inclusion in this directory is not an endorsement.