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A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact

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ClinicalTrials.gov Identifier: NCT03969992
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : July 6, 2021
Sponsor:
Information provided by (Responsible Party):
Aerogen Pharma Limited

Brief Summary:
The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome in Premature Infant Drug: AeroFact Other: nCPAP Phase 2

Detailed Description:

Part I Primary Objective To determine an optimal dose of AeroFact administered by nasal continuous positive airway pressure (nCPAP) versus stand of care in reducing the rate of intubation/cannulation and bolus surfactant instillation in the first 7 days after birth.

Part II Primary Objective To evaluate pulmonary outcomes and respiratory utilization at 3, 6, 9, and 12 months post-menstrual age (PMA)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Partially Blinded, Randomized, Parallel-Group Dose Ranging
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Masking within active arms
Primary Purpose: Treatment
Official Title: A Partially Blinded, Randomized, Controlled, Parallel-Group, Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact in Preterm Infants at Risk of Worsening Respiratory Distress Syndrome
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 30, 2021


Arm Intervention/treatment
nCPAP alone
Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary
Other: nCPAP
nCPAP (nasal continuous positive airway pressure) alone

Experimental: Drug: Low Dose AeroFact
AeroFact-low dose SF-RI 1
Drug: AeroFact
Aerosolized SF-RI 1
Other Name: SF-RI 1

Experimental: Drug: High Dose AeroFact
AeroFact-high dose SF-RI 1
Drug: AeroFact
Aerosolized SF-RI 1
Other Name: SF-RI 1




Primary Outcome Measures :
  1. Incidence of intubation/cannulation and instilled surfactant [ Time Frame: 7 days ]
    Number of patients who require intubation/cannulation with bolus surfactant instillation

  2. Percent of patients with respiratory symptoms requiring intervention across groups [ Time Frame: 12 months ]
    Comparison of respiratory symptoms (Asthma/URI) and respiratory medications between groups

  3. Percent of patients requiring supplemental oxygen and visits for medical care (Doctor's office/ER/Hospitalization) [ Time Frame: 12 months ]
    Assess need for supplemental oxygen and other respiratory support and visits to physician office/ER/hospitalizations between groups


Secondary Outcome Measures :
  1. Percent of patients requiring repeat surfactant dosing between groups [ Time Frame: 7 days ]
    Assess the need for more than one dose of surfactant between groups



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Ages Eligible for Study:   26 Weeks to 31 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)
  2. 26 0/7 to 30 6/7 weeks of gestational age
  3. Weight <2.0 Kg
  4. Respiratory Severity Score (RSS) 1.4-2.0

Exclusion Criteria:

  1. Apgar score less than or equal to 5 at five minutes after birth
  2. Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room
  3. Premature rupture of membranes (PROM) > 14 days
  4. Need for intubation and/or mechanical ventilation prior to enrollment
  5. Active pneumothorax requiring chest tube
  6. Significant congenital anomaly, chromosomal abnormality
  7. Concomitant treatments with inhaled nitric oxide

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): NCT03969992


Contacts
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Contact: Judy Doto, RN, BSN 484-716-5438 judydoto@aerogenpharma.com
Contact: Jeanette Asselin, MS 510-813-1177 jasselin@aerogenpharma.com

Locations
Show Show 35 study locations
Sponsors and Collaborators
Aerogen Pharma Limited
Investigators
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Study Director: Andy Clark, PhD Aerogen Pharma Corp
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Responsible Party: Aerogen Pharma Limited
ClinicalTrials.gov Identifier: NCT03969992    
Other Study ID Numbers: APC-AF-CLN-002
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: July 2020
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: No
Keywords provided by Aerogen Pharma Limited:
Respiratory Distress Syndrome
BPD
surfactant
Preterm Infant
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases