Bronchiolitis Acute Clinical Trial
Official title:
Prospective, Double-Blinded, Randomized, Multi-Center Study for Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis
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:
• Assess whether Nitric Oxide (NO) administered intermittently in 2 concentrations (via
inhalation for 40 minutes 4 times per day for up to 5 consecutive days) in addition to
Standard Supportive Treatment (SST) shortens the recovery time of infants with bronchiolitis,
compared to SST alone.
Secondary objectives:
- Time to achieve O2 saturation of ≥ 92 % sustained for at least 2 hours
- Reduction in hospital Length of Stay (LOS)
- Time to achieve mTal score of ≤ 5
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:
• Assess whether Nitric Oxide (NO) administered intermittently in 2 concentrations (via
inhalation for 40 minutes 4 times per day for up to 5 consecutive days) in addition to
Standard Supportive Treatment (SST) shortens the recovery time of infants with bronchiolitis,
compared to SST alone.
Secondary objectives:
- Time to achieve O2 saturation of ≥ 92 % sustained for at least 2 hours
- Reduction in hospital Length of Stay (LOS)
- Time to achieve mTal score of ≤ 5
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.
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