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...
Nitric Oxide is an investigational inhaled small molecule being developed by Beyond Air, Inc. for respiratory conditions including acute bronchiolitis, Mycobacterium abscessus infection, bronchiolitis, and cystic fibrosis. It is currently in clinical development and has not been approved by the FDA.
Nitric Oxide is being developed by Beyond Air, Inc., a biopharmaceutical company traded on NASDAQ under the ticker XAIR. The company is conducting clinical trials to evaluate the safety and efficacy of inhaled nitric oxide for various respiratory indications.
Nitric Oxide is in Phase 3 clinical development for respiratory indications. Beyond Air has completed Phase 1 and Phase 2 trials evaluating the drug in bronchiolitis, cystic fibrosis, and Mycobacterium abscessus infection. The drug remains investigational and is not yet FDA approved.
Nitric Oxide has been studied in several completed trials, including NCT01768884 and NCT04060979 for bronchiolitis, NCT01958944 for cystic fibrosis, and NCT03208764 for Mycobacterium abscessus infection. These trials were conducted in Israel and enrolled a total of 156 participants.
Nitric Oxide is a small molecule that acts as a signaling molecule in the body. When inhaled, it is believed to exert antimicrobial and anti-inflammatory effects in the respiratory tract, which may help treat infections and inflammation associated with conditions like bronchiolitis and cystic fibrosis.