Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04

NCT03748173 | Terminated Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: Aero-04
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness.

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• Improvement in Respiratory Status

  Incidence of positive respiratory response to Infasurf® Aerosol defined as Bronchiolitis Clinical Score decreased by 2 points or to ≤4.

  24 hours post PICU admission

Secondary Outcomes (1)

• Need of Respiratory support

  24 hours post PICU admission

Other Outcomes (1)

• Dose as Measured as duration of the therapy

  24 hours post PICU admission

Study Arms (2)

Treatment

EXPERIMENTAL

Subjects randomized to the aerosol surfactant evaluation will occur at the end of 60 minutes, with the aerosol continued if the bronchiolitis score is \> 4 or there has been less than a 2-point improvement in the bronchiolitis score. Similar evaluation will be performed, if necessary, at 30-minute intervals (maximum 2 hours) with stoppage of the aerosol for an improved bronchiolitis score (≤ 4 or 2-point improvement) at any of the time points. The aerosol would be stopped at any time for significant sustained deterioration in clinical status or any serious adverse event felt related to the treatment. Retreatment can be given at \> 4 but \< 24 hours if the initial response was positive and there has been subsequent deterioration.

Combination Product: Aerosolized Infasurf

Usual Care

NO INTERVENTION

The only difference in care between treatment and usual care will be treatment with up to two doses of aerosolized Infasurf®.

Interventions

Aerosolized Infasurf COMBINATION_PRODUCT

Infants randomized to aerosol treatment will receive Infasurf® aerosol at a rate of 12 ml/hour (the maximal rate using the Solaris CAG). The initial treatment will be for 60 minutes, with reevaluation every 30 minutes thereafter, with a maximum dose of 6 mL/Kg body weight or 2 hours of aerosolization. Treatment will be stopped after 60 minutes (and subsequently at 30-minute intervals) if a 2 point reduction in bronchiolitis score or a score ≤ 4 is achieved. Treatment will also be stopped at any time should there be evidence of other-than-transient deterioration in oxygenation or clinical status or for any serious adverse effect deemed by the infant's clinician to be possibly related to the drug administration.

Also known as: Calfactant

Treatment

Eligibility Criteria

• Age: 0 Months - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant ≤ 4 months of age admitted to the PICU with the clinical diagnosis of bronchiolitis
• Severe illness as reflected by a bronchiolitis score ≥ 4 and requiring high flow nasal cannula or continuous positive airway pressure for respiratory support
• Within 4 hours of PICU admission.

You may not qualify if:

• Need for non-invasive BiPAP or invasive ventilation
• Significant Co-morbidities
• Chronic lung disease (evidenced by supplemental oxygen, home ventilation, or chronic diuretic therapy for CLD)
• Unrepaired congenital heart disease
• Immune compromise
• Neuromuscular weakness
• Tracheostomy
• Influenza as the etiologic agent of bronchiolitis
• Inability to stabilize the infant to a bronchiolitis score \< 8

Sponsors & Collaborators

• ONY: lead

Study Sites (1)

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

calfactant

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 20, 2018
• Study Start: January 12, 2019
• Primary Completion: October 2, 2020
• Study Completion: October 21, 2020
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)