A Phase 2 interventional study of Nitric Oxide and Standard Supportive treatment in Bronchiolitis Acute, sponsored by Beyond Air Inc.. Completed at 7 sites in Israel. Open to participants aged 1 Day to 12 Months. Per ClinicalTrials.gov, last updated 2020-05-12.
Sponsored by Beyond Air Inc. · Phase 2, Interventional, and Treatment
Prospective, Double-Blinded, Randomized, Multi-Center Study for Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis
The proposed study judiciously expands these observations for use of NO treatment in pediatric patients with bronchiolitis aged less than 12 months. The intermittent dosing strategy used in this study has been selected to minimize the potential for adverse effects. The inclusion of two doses in the proposed pilot study is intended to determine a dose response effect and select a dose that is optimally safe and effective. The primary endpoint evaluation of time to fit for discharge will provide an effective objective measurement for the treatment effectiveness compared to standard supportive treatment of bronchiolitis.
Primary objective:
Secondary objectives:
Safety objectives: Characterize the safety of 2 doses of NO intermittent inhalation treatment therapy as measured by Adverse Events (AE) - number and percentage of subjects that experience AEs - and Serious Adverse Events (SAEs).
A total of 90 subjects will be enrolled into the study and randomized in a 1:1:1 ratio to receive the study treatments.
Treatment administration: Treatment blindness will be kept by designation of blinded and un-blinded team members.The blinded staff will be performing the study assessment procedures and the un-blinded team will be administering the actual treatment.
Subjects' parents/legal guardian will be contacted for a follow up phone call at days 14+5 and 30+5 from the date of enrollment of the subject into the study.
Prospective, Double-Blinded, Randomized, Multi-Center Study for Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis
Bronchiolitis is a viral disease, widely spread amongst young children with significant mortality in some cases and no specific treatment available, besides supportive treatment of O2 and hydration; therefore, there is an identified unmet medical need to develop a treatment strategy for children with bronchiolitis.
When the immune system's NO generating ability is overwhelmed or compromised, infection and disease occur. Increasing the body's ability to produce more NO through gene therapy or synthetic NO donor drugs is of interest in medicine.
NO, by itself, is an essential part of the innate defense mechanism of the human immune system which becomes up-regulated by the inducible NO synthase (iNOS) during various inflammatory conditions and during microbial and viral infections. This suggests that NO treatment in appropriate concentrations is highly relevant for children with bronchiolitis.
The two previous pilot studies conducted by Beyond Air (formerly known as AIT) found that intermittent exposure to was safe and well tolerated in pediatric subjects with acute bronchiolitis age 0-12 months and showed a trend in reduction in the length of hospitalization. The overall frequency of adverse events was found to be similar between the control and NO treated groups and intermittent exposure at 160 ppm did not result in exposure to unsafe Nitric Dioxide (NO2) levels or had a cumulative effect on MetHb levels.
The proposed study judiciously expands these observations for use of NO treatment in pediatric patients with bronchiolitis aged less than 12 months. The intermittent dosing strategy used in this study has been selected to minimize the potential for adverse effects. The inclusion of two doses in the proposed pilot study is intended to determine a dose response effect and select a dose that is optimally safe and effective. The primary endpoint evaluation of time to fit for discharge will provide an effective objective measurement for the treatment effectiveness compared to standard supportive treatment of bronchiolitis.
NO therapy can be cost effective, technologically simple and easily adaptive for use in inhaled pulmonary infections. Ultimately, therapeutic use of NO could be the initial treatment by mimicking the body's natural first line method to fight infections. Together, these results and rationale warrant the need to accelerate research of NO as a potential solution for front line treatment for bronchiolitis.
Primary objective:
Secondary objectives:
Safety objectives: Characterize the safety of 2 doses of NO intermittent inhalation treatment therapy as measured by Adverse Events (AE) - number and percentage of subjects that experience AEs - and Serious Adverse Events (SAEs).
A total of 90 subjects will be enrolled into the study and randomized in a 1:1:1 ratio to receive the study treatments.
Treatment administration: Treatment blindness will be kept by designation of blinded and un-blinded team members.The blinded staff will be performing the study assessment procedures and the un-blinded team will be administering the actual treatment.
Subjects' parents/legal guardian will be contacted for a follow up phone call at days 14+5 and 30+5 from the date of enrollment of the subject into the study.
360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.
This study's enrollment of 95 is above the median of 80 across 249 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →Beyond Air Inc. is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diagnosed with an underlying condition, which significantly affects respiratory system:
Genetic or neurological disorder capable of causing:
Presence of upper airway anomalies that may interfere with breathing, including:
Having the following signs or symptoms:
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.
Drug: Nitric Oxide · Other: Standard Supportive treatment
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.
Drug: Nitric Oxide · Other: Standard Supportive treatment
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.
Other: Standard Supportive treatment
Nitric Oxide given intermittently via inhalation
Standard Supportive treatment (including oxygen)
Time to "fit for 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).
Time frame: up to 14 days
Time to achieve O2 saturation of ≥ 92 %. sustained for at least 2 hours
The time in hours calculated from the time of patient's enrollment until the time required to achieve the endpoint.
Time frame: up to 14 days
Hospital Length of Stay (LOS)
LOS is measured in hours from the time of patient's enrollment in the study until the physician's order to discharge from the hospital. A patient will be evaluated for discharge from the hospital only after meeting the primary efficacy endpoint.
Time frame: up to 14 days
Modified Tal score [mTal] ≤5
The time in hours calculated from the time of patient's enrollment until the time required to achieve a clinical score of less than or equal to 5.
Time frame: up to 14 days
Incidence of Treatment-Emergent Adverse Events
Number of treatment-emergent adverse events (AEs) and Serious AEs
Time frame: Baseline to 30 days post dose
Admissions to ICU
Number of admissions to ICU
Time frame: from enrollment till end of follow up period (30+5 days from enrollment)
Duration of O2 supplementation (in hours)
Duration of O2 supplementation (in hours)
Time frame: up to 14 days
Level of O2 supplementation (in %)
Level of O2 supplementation (in %)
Time frame: up to 14 days
Nasopharyngeal swab testing for detecting respiratory viruses at baseline and end of treatment
Nasopharyngeal swab testing for detecting respiratory viruses at baseline and end of treatment. Will be performed for exploratory purposes only.
Time frame: up to 14 days
Readmission related to bronchiolitis
Readmission related to bronchiolitis - percentage of readmissions, related to bronchiolitis within 30 days from enrollment
Time frame: 30 days from enrollment
Plan to share: No
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Beyond Air Inc.