Evaluation of the Safety and Tolerability of Nitric Oxide (NO) Via Inhalation to Subjects With Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis; Respiratory Aspiration
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    


Intervention name(s): Nitric Oxide; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infants; Bronchiolitis; NO; inhalation