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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03053388 | Evaluation of the Efficacy Safety and Tolerability of Nitric Oxide Given Intermittently Via Inhalation to Subjects With Bronchiolitis | PHASE3 | COMPLETED | 69 | — | — | Mar 5, 2017 | Apr 28, 2018 | Jul 9, 2019 | 10 | Israel |
| NCT01768884 | Evaluation of the Safety and Tolerability of Nitric Oxide (NO) Via Inhalation to Subjects With Bronchiolitis | PHASE1 | COMPLETED | 43 | — | — | Jan 1, 2013 | Jan 1, 2016 | May 4, 2016 | 1 | Israel |
LOS is measured in hours from the time of first treatment dose to the time of physician decision to discharge.
| 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. |
| 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) |
| 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...