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

Primary Purpose

Respiratory Distress Syndrome in Premature Infant

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AeroFact
nCPAP
Sponsored by
Aerogen Pharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome in Premature Infant focused on measuring Respiratory Distress Syndrome, BPD, surfactant, Preterm Infant

Eligibility Criteria

26 Weeks - 31 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical SciencesRecruiting
  • Alta Bates SummitRecruiting
  • University of Colorado
  • University of Florida HealthRecruiting
  • Wolfson Children's HospitalRecruiting
  • South Miami HospitalRecruiting
  • Advent HealthRecruiting
  • Winnie Palmer Hospital
  • Northside Hospital AtlantaRecruiting
  • University of Illinois
  • Hospital of South BendRecruiting
  • University of KentuckyRecruiting
  • Barbara Bush Medical Center
  • University of MarylandRecruiting
  • Holy Cross HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Children's and Women's (C & W) Mott Hospital
  • Children's Health Care d/b/a Children's MinnesotaRecruiting
  • University of Minnesota Masonic Children's HospitalRecruiting
  • Mayo ClinicRecruiting
  • University of MississippiRecruiting
  • Dartmouth Hitchcock Medical CenterRecruiting
  • Maimonides HospitalRecruiting
  • Mount Sinai Kravis Children's HospitalRecruiting
  • NY Presbyterian Morgan Stanley Children's Hospital-Columbia
  • West Chester Medical Center-Maria Fareri Children's HospitalRecruiting
  • Levine Children's HospitalRecruiting
  • Grant HospitalRecruiting
  • Texas Health-Methodist HarrisRecruiting
  • Women's Hospital of TexasRecruiting
  • Children's Hospital of San Antonio (CHofSA)Recruiting
  • Methodist Children's HospitalRecruiting
  • North Central Baptist HospitalRecruiting
  • University of VirginiaRecruiting
  • University of WashingtonRecruiting
  • IWK HospitalRecruiting
  • The Ottawa Hospital
  • Mt. Sinai Hospital
  • CHU de Québec-Université Laval

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

nCPAP alone

Drug: Low Dose AeroFact

Drug: High Dose AeroFact

Arm Description

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

AeroFact-low dose SF-RI 1

AeroFact-high dose SF-RI 1

Outcomes

Primary Outcome Measures

Incidence of intubation/cannulation and instilled surfactant
Number of patients who require intubation/cannulation with bolus surfactant instillation
Percent of patients with respiratory symptoms requiring intervention across groups
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)
Assess need for supplemental oxygen and other respiratory support and visits to physician office/ER/hospitalizations between groups

Secondary Outcome Measures

Percent of patients requiring repeat surfactant dosing between groups
Assess the need for more than one dose of surfactant between groups

Full Information

First Posted
April 5, 2019
Last Updated
February 22, 2022
Sponsor
Aerogen Pharma Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03969992
Brief Title
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2020 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerogen Pharma Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome in Premature Infant
Keywords
Respiratory Distress Syndrome, BPD, surfactant, Preterm Infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Partially Blinded, Randomized, Parallel-Group Dose Ranging
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Masking within active arms
Allocation
Randomized
Enrollment
261 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nCPAP alone
Arm Type
Other
Arm Description
Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary
Arm Title
Drug: Low Dose AeroFact
Arm Type
Experimental
Arm Description
AeroFact-low dose SF-RI 1
Arm Title
Drug: High Dose AeroFact
Arm Type
Experimental
Arm Description
AeroFact-high dose SF-RI 1
Intervention Type
Drug
Intervention Name(s)
AeroFact
Other Intervention Name(s)
SF-RI 1
Intervention Description
Aerosolized SF-RI 1
Intervention Type
Other
Intervention Name(s)
nCPAP
Intervention Description
nCPAP (nasal continuous positive airway pressure) alone
Primary Outcome Measure Information:
Title
Incidence of intubation/cannulation and instilled surfactant
Description
Number of patients who require intubation/cannulation with bolus surfactant instillation
Time Frame
7 days
Title
Percent of patients with respiratory symptoms requiring intervention across groups
Description
Comparison of respiratory symptoms (Asthma/URI) and respiratory medications between groups
Time Frame
12 months
Title
Percent of patients requiring supplemental oxygen and visits for medical care (Doctor's office/ER/Hospitalization)
Description
Assess need for supplemental oxygen and other respiratory support and visits to physician office/ER/hospitalizations between groups
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percent of patients requiring repeat surfactant dosing between groups
Description
Assess the need for more than one dose of surfactant between groups
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
31 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed) 26 0/7 to 30 6/7 weeks of gestational age Weight <2.0 Kg Respiratory Severity Score (RSS) 1.4-2.0 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judy Doto, RN, BSN
Phone
484-716-5438
Email
judydoto@aerogenpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanette Asselin, MS
Phone
510-813-1177
Email
jasselin@aerogenpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy Clark, PhD
Organizational Affiliation
Aerogen Pharma Corp
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Pearson
Facility Name
Alta Bates Summit
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Han
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Florida Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Maddox, RN, BSN
Facility Name
Wolfson Children's Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Maddox, RN, BSN
Facility Name
South Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arturo Seize
Facility Name
Advent Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deb Ruth, RN, BSN
Facility Name
Winnie Palmer Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northside Hospital Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Grier, RN, BSN
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mashelle Monhaut, RN, NNP
Facility Name
University of Kentucky
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Nason
Facility Name
Barbara Bush Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Brengle, NP
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neha Talele
Facility Name
Children's and Women's (C & W) Mott Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Withdrawn
Facility Name
Children's Health Care d/b/a Children's Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy Worwa, RRT
Facility Name
University of Minnesota Masonic Children's Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jensina Erickson
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lavonne Liedl, RRT, RCP
Facility Name
University of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary McNally
Facility Name
Maimonides Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Nurse-Clarke, PhD
Facility Name
Mount Sinai Kravis Children's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
NY Presbyterian Morgan Stanley Children's Hospital-Columbia
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
West Chester Medical Center-Maria Fareri Children's Hospital
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clare Giblin, RN, BSN
Facility Name
Levine Children's Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Name
Grant Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Health-Methodist Harris
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Plant, RN, BSN
Facility Name
Women's Hospital of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of San Antonio (CHofSA)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katy Kohlleppel, RN, BSN
Facility Name
Methodist Children's Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katy Kohlleppel, RN, BSN
Facility Name
North Central Baptist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Drummond, RN, BSN
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22947
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Thielen
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Eldridge
Facility Name
IWK Hospital
City
Halifax
State/Province
Nova Scotia
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Mt. Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
CHU de Québec-Université Laval
City
Québec City
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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