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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748173
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
ONY

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Calfactant

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®.



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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748173


Contacts
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Contact: corey commaroto 7163614659 ccommaroto@onybiotech.com
Contact: Dan Swartz 716-418-2132 dswartz@onybiotech.com

Locations
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United States, Virginia
Children's Hospital of Richmond at VCU Recruiting
Richmond, Virginia, United States, 23298
Contact: Doug Willson, MD    804-828-4529    douglas.willson@vcuhealth.org   
Principal Investigator: Doug Willson, MD         
Sponsors and Collaborators
ONY

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Responsible Party: ONY
ClinicalTrials.gov Identifier: NCT03748173    
Other Study ID Numbers: Aero-04
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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