Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome

NCT04064684 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: HSC-MS-19-0566KL2TR003168
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to show that inhaled steroids in patient with PARDS can decrease the days on mechanical ventilator measured by ventilator-free days,to improve the oxygenation index (OI) or oxygenation saturation index (OSI) in patients receiving inhaled steroids and to show the relevance and feasibility of a larger study by assessing the hypothesis in a small cohort of patients. Patient will be treated for a maximum of 10 days. Secondary objectives are to reduce the length of stay (LOS) in the pediatric intensive care unit (PICU) and hospital admissions; to show less inflammation in the patients receiving inhaled steroids by measuring inflammatory markers from tracheal aspirates like Interleukin (IL6, IL8, tumor necrosis factor (TNF) α, matrix metalloproteinase8 (MMP8) and matrix metalloproteinase9 (MMP9). Lastly, to show that inhaled steroids can improve residual lung disease evaluated by Pulmonary Function Test (PFTs) and Impulse Oscillometry (IOS).

Conditions

Acute Respiratory Distress Syndrome

Keywords

Pediatric acute respiratory distress syndrome; PARDS; Budesonide; inhaled steroids

Outcome Measures

Primary Outcomes (1)

• Number of Ventilator-free Days (VFD)

  Between the time of enrollment and day 28 after enrollment

Secondary Outcomes (29)

• Oxygenation Index (OI)

  Day one to last day of last day of mechanical ventilation (up to 10 days)

• Oxygen Saturation Index (OSI)

  Day one to last day of last day of mechanical ventilation up to 28 days since enrollment

• Number of Days Participant Stayed in Pediatric Intensive Care Unit (PICU)

  from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)

• Number of Days Participant Stayed in Hospital

  from time of enrollment until participant is transferred, discharged, or deceased (up to 50 days)

• TNF Alpha Levels as Assessed by the Enzyme-linked Immunosorbent Assay (ELISA) Test

  Day 1

Study Arms (2)

Budesonide administered by nebulizer

EXPERIMENTAL

Drug: Budesonide; Device: Nebulizer

Placebo administered by nebulizer

PLACEBO COMPARATOR

Drug: Placebo; Device: Nebulizer

Interventions

Budesonide DRUG

Enrolled patients will be treated with Pulmicort Respules® (Budesonide inhalation suspension), at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator. The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.

Also known as: Pulmicort Respules®

Budesonide administered by nebulizer

Placebo DRUG

Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.

Placebo administered by nebulizer

Nebulizer DEVICE

The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit.

Budesonide administered by nebulizer; Placebo administered by nebulizer

Eligibility Criteria

• Age: 30 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients older than 30 days and up to 18 years of age admitted to the PICU with a diagnosis of PARDS enrolled within 72 hours of diagnosis.
• Patients requiring invasive mechanical ventilation.
• Criteria of PARDS as defined by the Pediatric Acute Lung Injury Consensus Conference (PALICC), on June 2015 in Pediatric Critical Care Journal

You may not qualify if:

• Patients with diffuse alveolar hemorrhage.
• Patients terminally ill with limitation of care or in hospice care.
• Patients receiving inhaled steroids or systemic steroids as chronic therapy before admission.
• Patients with high dose systemic steroids for anti-inflammatory purposes. The investigators will not exclude patients receiving hydrocortisone for shock.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Budesonide; Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Equipment and Supplies

Limitations and Caveats

Enrollment difficulties after start of the COVID-19 pandemic leading to small sample size

Results Point of Contact

• Title: Alvaro Jose Coronado Munoz, MD
• Organization: The University of Texas Health Science Center at Houston

Alvaro.J.CoronadoMunoz@uth.tmc.edu

713-500-5553

Study Officials

• Alvaro J Coronado Munoz, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 22, 2019
• Study Start: February 4, 2020
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: July 13, 2022
• Results First Posted: May 31, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)