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

• ClinicalTrials.gov Identifier: NCT03748173
• Recruitment Status: Terminated
• First Posted: November 20, 2018
• Last Update Posted: October 23, 2020
• Sponsor: ONY
• Information provided by (Responsible Party): ONY

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bronchiolitis	Combination Product: Aerosolized Infasurf	Phase 1

Detailed Description:

This pilot clinical trial will compare "usual care" to aerosolized Infasurf. The study objective is to determine

1. Do bronchiolitis patients tolerate aerosolized Infasurf?
2. Does aerosolized Infasurf induce an improvement in respiration?
3. If it does how large a dose is required to observe a positive effect?
4. Is the positive effect transient, if so what is the range of duration of the effect?
5. Does retreatment also result and a positive response?
6. Does aerosolized Infasurf result in more rapid sustained improvement? is superior to.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants
• Actual Study Start Date: January 12, 2019
• Actual Primary Completion Date: October 2, 2020
• Actual Study Completion Date: October 21, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; 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; 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.; Other Name: Calfactant
No Intervention: Usual Care; The only difference in care between treatment and usual care will be treatment with up to two doses of aerosolized Infasurf®.

Outcome Measures

Primary Outcome Measures :

1. Improvement in Respiratory Status [ Time Frame: 24 hours post PICU admission ]
   Incidence of positive respiratory response to Infasurf® Aerosol defined as Bronchiolitis Clinical Score decreased by 2 points or to ≤4.

Secondary Outcome Measures :

1. Need of Respiratory support [ Time Frame: 24 hours post PICU admission ]
   Incidence of need for non-invasive (BiPAP, NIV-NAVA) or invasive ventilation

Other Outcome Measures:

1. Dose as Measured as duration of the therapy [ Time Frame: 24 hours post PICU admission ]
   To determine the optimal dose/duration of aerosolized Infasurf® in infants with bronchiolitis by aerosolizing Infasurf at 35mg/ml at a rate of 1.8 to 2.2 mls per minute until therapeutic response is achieved or the maximum amount of a single dose is reached.

Eligibility Criteria

• Ages Eligible for Study: 0 Months to 4 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Need for non-invasive BiPAP or invasive ventilation

2. Significant Co-morbidities

   1. Chronic lung disease (evidenced by supplemental oxygen, home ventilation, or chronic diuretic therapy for CLD)
   2. Unrepaired congenital heart disease
   3. Immune compromise
   4. Neuromuscular weakness
3. Tracheostomy
4. Influenza as the etiologic agent of bronchiolitis
5. Inability to stabilize the infant to a bronchiolitis score < 8

Contacts and Locations

Locations

United States, Virginia

Children's Hospital of Richmond at VCU

Richmond, Virginia, United States, 23298

Sponsors and Collaborators

ONY

More Information

• Responsible Party: ONY
• ClinicalTrials.gov Identifier: NCT03748173
• Other Study ID Numbers: Aero-04
• First Posted: November 20, 2018
• Last Update Posted: October 23, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Bronchiolitis; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Calfactant; Pulmonary Surfactants; Respiratory System Agents