Evaluation of the Safety and Tolerability of Nitric Oxide (NO) Via Inhalation to Subjects With Bronchiolitis
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
Prospective, Double Blind, Randomized Single-Center, Evaluation of Safety and Tolerability of
Nitric Oxide Given Intermittently via Inhalation to Subjects with Bronchiolitis-Phase IIa
Bronchiolitis is defined as an infection of the small airways. It is also the most common
manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the
leading cause of global child mortality. NO has been shown to play a critical role in various
biological functions, including the vasodilatation of smooth muscle, neurotransmission,
regulation of wound healing and immune responses to infection such as microbicidal action
directed toward various organisms. NO in the airways is considered to play a key role in the
innate immune system in which the first-line of host defense against microbes is built.
It has shown the beneficial effect of NO in different diseases with several options of doses
and regimens - from newborn with primary pulmonary hypertension which showed improvement in
oxygenation after 30 minutes of NO treatment at 10-20 ppm, to a subject with adult
respiratory distress syndrome, who demonstrated clinical improvement during NO treatment at
18 and 36 ppm.
In vitro studies utilizing a variety of nitric oxide (NO) donors suggested that NO, in part
per million (ppm) concentrations, possesses antimicrobial and anti-viral activity against a
wide variety of phyla including bacteria, viruses, helminthes and parasites.
Primary Objectives: Assess the safety of NO intermittent inhalation treatment in 2-12 month
old bronchiolitis subjects. Assess the tolerability of NO intermittent inhalation treatment
in 2-12 month old bronchiolitis subjects Secondary Objective: Assess the efficacy of NO
intermittent inhalation treatment compared to standard treatment in 2-12 months old
bronchiolitis subjects.
Prospective, double blind, randomized single-Center study of 44 hospitalized subjects aged 2
-12 months old, diagnosed with bronchiolitis will be enrolled into the study and randomized
into 2 groups. Group 1 -Treatment group - Will receive nitric oxide inhalation in addition to
standard treatment for up to 5 days, Group 2 - will receive ongoing inhalation of the
standard treatment for 5 days.
Treatment administration: Treatment blindness will be kept by separating between unblinded
team members (giving the actual treatment) and blinded team members, and by hiding the NO
container and all study related equipment behind a curtain. Between study inhalations the
subject will continue to receive the standard inhalation treatment. Oxygen (O2), NO ,
nitrogen dioxide(NO2)and fraction of inspired oxygen (FiO2) delivered to the patient will be
continuously monitored.
All subjects will come for follow up visits on day 7(+5), 14 (+5) days and will be contacted
on day 30 (+5) from day of admission to the department.
End of study treatment (both groups) will be assessed by a blinded study physician base on
clinical assessment. Subject improvement that will lead to end study treatment = clinical
score < 6 and/or (Oxygen saturation)SaO2 above 92% and/or decision of subject discharge from
the hospital.