Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as treprostinil SMI (treprostinil inhalation spray)
treprostinil SMI · 2 trials · 1 indication
Number and type of AEs and SAEs observed in participants during and after use of treprostinil SMI.
FEV1 is a standard indicator of lung function and measures the maximal amount of air forcefully exhaled in 1 second.
FVC is a standard indicator of lung function and measures the amount of air a person can forcefully and quickly exhale after taking a deep breath.
The FEV1/FVC ratio measures how much air is exhaled in one second compared to a full breath. This helps determine if the lung condition is restrictive or obstructive and its severity.
TLC is a standard indicator of lung function and measures the maximum volume of lung capacity after very deep inhalation.
DLCO is a standard indicator of lung function and measures how well oxygen moves from the lungs to the blood.
Pulse oximetry will measure SpO2 as a percentage, indicating hypoxemia and respiratory distress.
Supplemental oxygen use, as measured in L, indicates chronic hypoxemia.
The 12-lead ECG measures electrical cardiac activity, including heart rate and rhythm (PR interval, QT interval, QT interval corrected for heart rate by Fridericia's formula, and QRS duration).
Number and type of serious adverse events, severe adverse events, cardiopulmonary hospitalizations, and deaths observed in participants during and after use of inhaled treprostinil and placebo.
| Arm | Type | Description |
|---|---|---|
| treprostinil SMI | EXPERIMENTAL | Inhaled treprostinil administered via a SMI at concentrations of 1.34, 2.68, 4.02, 5.36 and 6.70 mg/mL |
| placebo | PLACEBO_COMPARATOR | Inhaled placebo administered via a SMI |
| Name | Type | Description |
|---|---|---|
| treprostinil SMI (treprostinil inhalation spray) | COMBINATION_PRODUCT | Inhaled treprostinil administered via a SMI four times daily in concentrations of 1.34, 2.68, 4.02, 5.36, and 6.70 mg/mL |
| Placebo (placebo inhalation spray) | COMBINATION_PRODUCT | Placebo administered via a SMI |
Inclusion Criteria: 1. Voluntarily give informed consent to participate in the study 2. Willing and able to comply with scheduled study visits, study treatment, laboratory tests, and all other study-related procedures 3. Enrolled in a previous study evaluating treprostinil SMI for PH-COPD, remained...