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

NCT03969992 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: APC-AF-CLN-002
• Study Type: interventional
• Target: 261
• Locations: 2 countries
• Sites: 41

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.

Conditions

Respiratory Distress Syndrome in Premature Infant

Keywords

Respiratory Distress Syndrome; BPD; surfactant; Preterm Infant

Outcome Measures

Primary Outcomes (1)

• Intubation/Cannulation and Instilled Surfactant

  Number of patients who require intubation/cannulation with bolus surfactant instillation

  First 7 days of life

Secondary Outcomes (5)

• Time to First Intubation/Cannulation and Bolus Surfactant Instillation

  First 7 days of life

• Proportion of Infants Who Received Multiple Doses of Bolus Surfactant

  First 7 days of life

• Number of Days on Invasive Mechanical Ventilation

  Assessed daily from birth to 40 weeks post-menstrual age or discharge

• Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post-menstrual Age (PMA)

  Birth to 36 weeks post-menstrual age

• Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 40 Weeks Post-menstrual Age (PMA)

  Birth to 40 weeks post-menstrual age

Study Arms (3)

nCPAP alone

OTHER

Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary

Other: nCPAP

Drug: Low Dose AeroFact

EXPERIMENTAL

AeroFact-low dose SF-RI 1

Drug: AeroFact

Drug: High Dose AeroFact

EXPERIMENTAL

AeroFact-high dose SF-RI 1

Drug: AeroFact

Interventions

AeroFact DRUG

Aerosolized SF-RI 1

Also known as: SF-RI 1

Drug: High Dose AeroFact; Drug: Low Dose AeroFact

nCPAP OTHER

nCPAP (nasal continuous positive airway pressure) alone

nCPAP alone

Eligibility Criteria

• Age: 26 Weeks - 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)
• /7 to 30 6/7 weeks of gestational age
• Weight \<2.0 Kg
• Respiratory Severity Score (RSS) 1.4-2.0

You may not qualify if:

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

Sponsors & Collaborators

• Aerogen Pharma Limited: lead

Study Sites (41)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Alta Bates Summit

Berkeley, California, 94705, United States

Location

Children's Hospital Orange County

Orange, California, 92868, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Florida Health

Jacksonville, Florida, 32209, United States

Location

Wolfson Children's Hospital

Jacksonville, Florida, 32209, United States

Location

South Miami Hospital

Miami, Florida, 33146, United States

Location

Advent Health

Orlando, Florida, 32803, United States

Location

Winnie Palmer Hospital

Orlando, Florida, 32806, United States

Location

Northside Hospital Atlanta

Atlanta, Georgia, 30042, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Barbara Bush Medical Center

Portland, Maine, 04102, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Holy Cross Hospital

Silver Spring, Maryland, 20910, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Children's and Women's (C & W) Mott Hospital

Ann Arbor, Michigan, 48109, United States

Location

Children's Health Care d/b/a Children's Minnesota

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi

Jackson, Mississippi, 39216, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Maimonides Hospital

Brooklyn, New York, 11219, United States

Location

Mount Sinai Kravis Children's Hospital

New York, New York, 10029, United States

Location

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

NY Presbyterian Morgan Stanley Children's Hospital-Columbia

New York, New York, 10032, United States

Location

West Chester Medical Center-Maria Fareri Children's Hospital

Valhalla, New York, 10595, United States

Location

Levine Children's Hospital

Charlotte, North Carolina, 28203, United States

Location

Grant Hospital

Columbus, Ohio, 43205, United States

Location

Texas Health-Methodist Harris

Fort Worth, Texas, 76104, United States

Location

Women's Hospital of Texas

Houston, Texas, 77054, United States

Location

Children's Hospital of San Antonio (CHofSA)

San Antonio, Texas, 78207, United States

Location

Methodist Children's Hospital

San Antonio, Texas, 78229, United States

Location

North Central Baptist Hospital

San Antonio, Texas, 78258, United States

Location

University of Virginia

Charlottesville, Virginia, 22947, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

IWK Hospital

Halifax, Nova Scotia, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Mt. Sinai Hospital

Toronto, Ontario, Canada

Location

CHU de Québec-Université Laval

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth

Interventions

SF-RI 1, bovine surfactant preparation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: David Durand, MD
• Organization: Aerogen Pharma

ddurand@aerogenpharma.com

510-928-2111

Study Officials

• David Durand, MD

  Aerogen Pharma Corp

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking within active arms
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Partially Blinded, Randomized, Parallel-Group Dose Ranging

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: May 31, 2019
• Study Start: March 4, 2020
• Primary Completion: August 4, 2023
• Study Completion: August 5, 2024
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (37); CA (4)