Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01728220 | Two-Part Dose-Confirming Study of Pulsed Inhaled Nitric Oxide in Subjects With WHO Group 3 Pulmonary Hypertension Associated With COPD | PHASE2 | COMPLETED | 159 | — | — | Dec 1, 2012 | Jul 1, 2014 | Feb 27, 2023 | 43 | United States |
| Arm | Type | Description |
|---|---|---|
| Inhaled NO @ 0.003 mg/kg/ ideal body weight (IBW)/hr (Part A) | ACTIVE_COMPARATOR | Inhaled NO using 3.0 mg/L \[2440 ppm\] NO minicylinder delivered via INOpulse® DS-C device |
| Inhaled NO @ 0.010 mg/kg/IBW/hr (Part A) | ACTIVE_COMPARATOR | Inhaled NO using 3.0 mg/L \[2440 ppm\] NO minicylinder delivered via INOpulse® DS-C device |
| Inhaled NO @ 0.015 mg/kg/IBW/hr (Part A) | ACTIVE_COMPARATOR | Inhaled NO using 6.0 mg/L \[4880 ppm\] NO minicylinder delivered via INOpulse® DS-C device |
| Placebo random @ 0.003, 0.010 or 0.015 mg/kg/IBW/hr (Part A) | PLACEBO_COMPARATOR | Placebo using 99.999% N2 minicylinder delivered via INOpulse® DS-C device |
| Inhaled NO @ 0.030 mg/kg IBW/hr (Part B) | ACTIVE_COMPARATOR | Inhaled NO using 6.0 mg/L \[4880 ppm\] NO minicylinder delivered via INOpulse® DS-C device |
| Inhaled NO @ 0.075 mg/kg IBW/hr (Part B) | ACTIVE_COMPARATOR | Inhaled NO using 6.0 mg/L \[4880 ppm\] NO minicylinder delivered via INOpulse® DS-C device |
| Placebo random @ 0.030 or 0.075 mg/kg/IBW (Part B) | ACTIVE_COMPARATOR | Placebo using 99.999% N2 minicylinder delivered via INOpulse® DS-C device |
| Name | Type | Description |
|---|---|---|
| Inhaled NO delivered via INOpulse DS-C Device | COMBINATION_PRODUCT | Subjects will be treated with nitric oxide by means of an INOpulse DS-C device using an INOpulse nasal cannula. |
| Placebo delivered via INOpulse DS-C Device | COMBINATION_PRODUCT | Subjects will be treated with nitrogen gas by means of an INOpulse DS-C device using an INOpulse nasal cannula. |
Inclusion Criteria: 1. Former smokers with at least 10 pack-years of tobacco cigarette smoking history before study entry and who have stopped smoking ≥ 1 month prior to enrollment 2. Age ≥ 40 years, ≤ 80 years 3. A confirmed diagnosis of COPD by the Global initiative for chronic Obstructive Lung D...