Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nitric Oxide · 5 trials · 4 indications
LOS is measured in hours from the time of first treatment dose to the time of physician decision to discharge.
Time to "fit for discharge". "Fit for discharge" is a composite endpoint measured by the following: * Achieving Modified Tal score \[mTal\] ≤ 5 And * Oxygen saturation (SpO2) ≥92% at room air (without oxygen supplementation) sustained for at least 2 hours Both of these will be determined from the time of enrollment (when the ICF is signed).
| Arm | Type | Description |
|---|---|---|
| Group 1 - Nitric Oxide treatment | EXPERIMENTAL | • Group 1 (NO treatment) - will receive inhalations of 160 ppm NO combined with O2/air for 30 minutes, every 3-4.5 hours, five times a day (24 hours), for up to 5 days (maximum 25 inhalations), in addition to standard supportive treatment. |
| Group 2 - Control treatment | ACTIVE_COMPARATOR | • Group 2 (Control) - will receive inhalations O2/air using the same treatment schedule and equipment as group 1, in addition to standard supportive treatment. |
| Group 1- NO treatment- dose 1 | EXPERIMENTAL | Will comprise of approximately 30 patients and will receive inhalations of dose 1 of NO combined with O2/air for 40 minutes, every 4.5 hours during the day four times a day for up to 5 days in addition to standard supportive treatment. |
| Group 2- NO treatment- dose 2 | EXPERIMENTAL | Will comprise of approximately 30 patients and will receive inhalations of dose 2 of NO combined with O2/air for 40 minutes, every 4.5 hours during the day four times a day for up to 5 days in addition to standard supportive treatment. |
| Group 3- Control treatment | OTHER | Will comprise of approximately 30 patients and will receive O2/air using the same treatment schedule and equipment as groups 1 and 2, in addition to standard supportive treatment. |
| Nitric Oxide treatment | EXPERIMENTAL | - |
| Nitric oxide + standard treatment | EXPERIMENTAL | Inhalation of 160 ppm NO for 30 minutes, 3 times daily, for a duration of 10 working days with the exclusion of weekend days (Friday \& Saturday) in which no treatment under this study will be provided. |
| Nitric oxide inhalation + standard treatment | EXPERIMENTAL | Inhalation of 160 ppm gNO for 30 minutes, 5 times daily, for 5 consecutive days or until discharged, which occurs first. |
| Standard treatment | PLACEBO_COMPARATOR | Standard treatment |
| Name | Type | Description |
|---|---|---|
| Nitric Oxide | DRUG | Nitric Oxide given via inhalation in cycles |
| Supportive treatment | OTHER | Supportive treatment (including oxygen) |
| Standard Supportive treatment | OTHER | Standard Supportive treatment (including oxygen) |
| Placebo | DRUG | - |
Inclusion Criteria: 1. 1\. Pediatric subjects 0-12-months old. a. Including subjects born at ≥28 weeks of gestation. 2. Subjects with acute bronchiolitis requiring in-patient hospitalization expected for 24 hours and more. 3. Clinical score of between 7 to 10 at Screening (without oxygen supple...