Respiratory Distress SyndromePhase 3NCT06776783
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
A Phase 3 study testing APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system) in people with Respiratory Distress Syndrome and Pre-term Infants, run by Aerogen Pharma Limited at 31 sites in 3 countries.
Trial summary
This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). Read more about this study
- Who is it for?
- Ages 1 hour to 24 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Pre-term Infants
- What is being tested?
- APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 31 sitesin 3 countries
- Study dates
- 24 Sep 2025to May 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)
- Gestational age at birth of 26 through 33 weeks PMA
- Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)
- Birth weight ≤ 2000 grams
- Post-natal age 1 to 24 hours at randomization
- On nCPAP or NIV for at least 30 minutes with RSS = 1.4 - 2.0 to maintain SpO2 90-95% at randomization. RSS is calculated as (nCPAP cm H2O) × (FiO2) or as (NIV mean airway pressure cm H2O) × (FiO2).
Show all 9Show fewer
- FiO2 ≥ 0.24 at randomization
- nCPAP or mPaw ≥ 6 cm H2O at randomization
- Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization
Who cannot join
- On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (> 2 liters per minute [LPM]) at the time of randomization
- Prior instillation of surfactant
- Premature rupture of membranes (PROM) occurring > 14 days before birth
- Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)
- Pneumothorax
- Other etiologies of respiratory distress
Show all 12Show fewer
- Enrollment in another interventional study with similar efficacy endpoints
- Apgar score at 5 min of 0-3
- Prior cardiopulmonary resuscitation (CPR) or epinephrine
- Base Deficit > 15 mEq/L on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization. Note that arterial blood gas is not required prior to randomization.
- Partial pressure of carbon dioxide (PaCO2) > 65 mmHg on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization.
- Triplet or higher order multiple birth
Trial locations and contacts
31 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 3 countries
United States18 sites, 18 recruiting
- Recruiting
University of Maryland Children's Hospital
Baltimore, Maryland, 21201
Lisa Brengle, 410-706-1422, lbrengle@som.umaryland.edu
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Juliet Ali-Caccamo, 617-636-2393, j.ali-caccamo@tuftsmedicalcenter.org
- Recruiting
University of Virginia Children's Hospital
Charlottesville, Virginia, 22903
Heeju Yang, CCRP, 434-529-0304, hvw8cy@uvahealth.org
- Recruiting
UF Health Jacksonville
Jacksonville, Florida, 32209
Megan Mathews, 904-244-5450, megan.mathews@ufhealth.org
- Recruiting
Jacobs Medical Center
La Jolla, California, 92037
Sarah Lazar, MPH, 858-249-1711, NICUstudies@health.ucsd.edu
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Vonita Chawla, MD, 501-364-1028, vchawla@uams.edu
- Recruiting
WVU Medicine Children's Hospital
Morgantown, West Virginia, 26506
Mark Polak, MD, PhD, 304-293-1202, mpolak@hsc.wvu.edu
- Recruiting
Goryeb Children's Hospital
Morristown, New Jersey, 07960
John Ladino, MD, 973-971-5488, John.Ladino@atlantichealth.org
- Recruiting
Mount Sinai Hospital
New York, New York, 10024
Courtney Juliano, MD, 212-241-6936, courtney.juliano@mssm.edu
- Recruiting
The Trustees of Columbia University in the City of New York
New York, New York, 10032
Rakesh Sahni, MD, 212-305-8500, r262@cumc.columbia.edu
- Recruiting
Advent Health
Orlando, Florida, 32803
Narendra Dereddy, MD, 407-609-3280, Narendra.Dereddy.MD@adventhealth.com
- Recruiting
University of Pittsburgh Medical Center Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
Emma Cribbs, 412-692-7750, cribbsel@upmc.edu
- Recruiting
University of California Davis Children's Hospital
Sacramento, California, 95817
Akina Shimizu, 916-734-3125, ashimizu@health.ucdavis.edu
- Recruiting
Christus Children's Hospital
San Antonio, Texas, 78207
Terri Newsom, 210-704-2823, Terriel.newsom@christushealth.org
- Recruiting
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
Anup Katheria, 858-939-6307, anup.katheria@sharp.com
- Recruiting
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Amber Wallace, 574-647-7141, awallace@beaconhealthsystem.org
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Ibadete Xama, MBA, Ibadete.xama@einsteinmed.edu
- Recruiting
Maria Farreri Children's Hospital
Valhalla, New York, 10595
Edmund F LaGamma, MD, 914-493-8558, edmund_lagamma@nymc.edu
United Kingdom7 sites, 7 recruiting
- Recruiting
Royal Jubilee Maternity Hospital
Belfast, BT12 6BB
Adam Reynolds, MD, 447341887046, Adam.Reynolds@belfasttrust.hscni.net
- Recruiting
The Royal London Hospital
London, E1 1FR
Ajay Sinha, MD, 442035940526, ajay.sinha@nhs.net
- Recruiting
Whipps Cross University Hospital
London, E11 1NR
John Ho, MD, 442085395522 ext. 26623, john.ho3@nhs.net
- Recruiting
Newham University Hospital
London, E13 8SL
Mohammad Alam, MD, 442073639382, mohammad.alam12@nhs.net
- Recruiting
University College Hospital
London, WC1E 6DB
Howard Clark, 442034479400, h.clark@ucl.ac.uk
- Recruiting
Royal Preston Hospital
Preston, PR2 9HT
Richa Gupta, MD, 441772524423, richa.gupta@lthtr.nhs.uk
- Recruiting
Princess Royal Hospital
Telford, TF1 6TF
Sanjeev Deshpande, MD, 441958565976, sanjeev.desphande@nhs.net
Canada6 sites, 6 recruiting
- Not yet recruiting
Royal Alexandria Hospital
Edmonton, Alberta, T5H 3V9
Georg Schmolzer, MD, 780-735-4666, schmolzer@ualberta.ca
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Walid El-Naggar, MD, 902-470-6466, walid.el-naggar@iwk.nshealth.ca
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1
Amit Mukerji, 905-521-2100 ext. 75721, mukerji@mcmaster.ca
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Brigitte Lemyre, 613-737-8899 ext. 71882, blemyre@toh.ca
- Recruiting
CHU de Québec-Université Laval
Québec, Quebec, G1V 4G2
Georges Caouette, MD, 418-525-4444 ext. 72100, georges.caouette@crchudequebec.ulaval.ca
- Recruiting
Mount Sinai Hospital Toronto
Toronto, Ontario, M5G 1X5
Laura Thomas, 416-586-4800 ext. 172060, laura.thomas@sinaihealth.ca
About this study
Official title: A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of APC-0101 (SF-RI 1 Surfactant for Inhalation Combined With a Dedicated Delivery System) in Preterm Infants With Respiratory Distress Syndrome
This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 24 months corrected age.
- Conditions
- Respiratory Distress Syndrome, Pre-term Infants
- Being tested
- APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system), Control
- Keywords
- respiratory distress syndrome, surfactant, pre-term infant
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)Combination product
Subjects in the APC-0101 group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface and APC-0101 treatment will be started.
ControlOther
Subjects in the Control group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface but an empty vial will be used instead of APC-0101.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | Not described Receives: Other: Control |
| APC-0101 Group | Experimental | Not described Receives: Combination Product: APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure Criteria
Number (%) of subjects who meet the predetermined criteria for failure of nCPAP/NIV
Measured: First 7 days of life
Secondary outcomes (3)
Instilled Bolus Surfactant
The number (%) of subjects in each group who receive instilled bolus surfactant.
Measured: First 72 hours of life
Multiple Bolus Surfactant Doses
The number (%) of subjects in each group who receive multiple doses of bolus surfactant.
Measured: First 72 hours of life
Total Number of Bolus Surfactant Doses
The total number of bolus doses of surfactant received per subject in each group.
Measured: First 72 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start24 Sep 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aerogen Pharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776783
- Sponsor's protocol ID
- APC-AF-CLN-003
- Status last verified
- Oct 2026
- First submitted
- 10 Jan 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of APC-0101 (SF-RI 1 Surfactant for Inhalation Combined With a Dedicated Delivery System) in Preterm Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT06776783
- Acronym / sponsor ID
- APC-AF-CLN-003
- Conditions
- Respiratory Distress Syndrome, Pre-term Infants
- Keywords
- respiratory distress syndrome, surfactant, pre-term infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Aerogen Pharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 24 months corrected age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Other: Control |
| APC-0101 Group | Experimental | Combination Product: APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system) |
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)
- Gestational age at birth of 26 through 33 weeks PMA
- Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)
- Birth weight ≤ 2000 grams
- Post-natal age 1 to 24 hours at randomization
Key exclusion criteria (12 listed)
- On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (> 2 liters per minute [LPM]) at the time of randomization
- Prior instillation of surfactant
- Premature rupture of membranes (PROM) occurring > 14 days before birth
- Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)
- Pneumothorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)Subjects in the APC-0101 group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface and APC-0101 treatment will be started. | Combination product | APC-0101 Group |
| ControlSubjects in the Control group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface but an empty vial will be used instead of APC-0101. | Other | Control Group |
Primary outcome
Failure Criteria
Time frame: First 7 days of life
Number (%) of subjects who meet the predetermined criteria for failure of nCPAP/NIV
3 secondary outcomes
Instilled Bolus Surfactant
Time frame: First 72 hours of life
Multiple Bolus Surfactant Doses
Time frame: First 72 hours of life
Total Number of Bolus Surfactant Doses
Time frame: First 72 hours of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system) in people with Respiratory Distress Syndrome and Pre-term Infants, run by Aerogen Pharma Limited at 31 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director (9196026411, AF3inquiries@aerogenpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure Criteria (time frame: First 7 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.