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Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis

NCT04060979 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2020-05-12

No results posted yet for this study

Summary

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.

Conditions

  • Bronchiolitis Acute

Interventions

DRUG

Nitric Oxide

Nitric Oxide given intermittently via inhalation

OTHER

Standard Supportive treatment

Standard Supportive treatment (including oxygen)

Sponsors & Collaborators

  • Beyond Air Inc.

    lead INDUSTRY

Principal Investigators

  • Aviv Goldbart · Soroka University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-06
Primary Completion
2020-03-02
Completion
2020-04-02

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04060979 on ClinicalTrials.gov