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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

Tracking Information
First Submitted Date  ICMJE April 5, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date July 6, 2021
Actual Study Start Date  ICMJE March 4, 2020
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • Incidence of intubation/cannulation and instilled surfactant [ Time Frame: 7 days ]
    Number of patients who require intubation/cannulation with bolus surfactant instillation
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
Official Title  ICMJE 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
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.
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Respiratory Distress Syndrome in Premature Infant
Intervention  ICMJE
  • Drug: AeroFact
    Aerosolized SF-RI 1
    Other Name: SF-RI 1
  • Other: nCPAP
    nCPAP (nasal continuous positive airway pressure) alone
Study Arms  ICMJE
  • nCPAP alone
    Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary
    Intervention: Other: nCPAP
  • Experimental: Drug: Low Dose AeroFact
    AeroFact-low dose SF-RI 1
    Intervention: Drug: AeroFact
  • Experimental: Drug: High Dose AeroFact
    AeroFact-high dose SF-RI 1
    Intervention: Drug: AeroFact
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 30, 2019)
261
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 26 Weeks to 31 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Judy Doto, RN, BSN 484-716-5438 judydoto@aerogenpharma.com
Contact: Jeanette Asselin, MS 510-813-1177 jasselin@aerogenpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03969992
Other Study ID Numbers  ICMJE APC-AF-CLN-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aerogen Pharma Limited
Study Sponsor  ICMJE Aerogen Pharma Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andy Clark, PhD Aerogen Pharma Corp
PRS Account Aerogen Pharma Limited
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP