Trial · NCT02452476

A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)

NCT02452476, Phase 2, Completed, Chiesi Farmaceutici S.p.A.; results first posted 2021-06-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC). Trials, record NCT02452476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02452476

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)
NCT number: NCT02452476
Status: Completed
Phases: Phase 2
Enrollment: 123 participants, actual
Lead sponsor: Chiesi Farmaceutici S.p.A.
Conditions: Respiratory Distress Syndrome, Newborn
Interventions: CHF5633, Poractant alfa
First posted: 2015-05-22
Last updated: 2021-08-13
Results first posted: 2021-06-23

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio	Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7	SpO2/FiO2 ratio The oxygen requirement and ventilatory support were assessed through arterial oxygen saturation, measured by pulse oximetry (SpO2 \[%\]) and ventilator settings, by measuring fraction of inspired oxygen (FiO2\[%\]) and SpO2/FiO2. Results are shown as change from baseline, summarized at post-treatment timepoints. Definitions: SpO2=Arterial Oxygen saturation by pulse oximetry; FiO2=Fraction of inspired oxygen; Baseline=The last pre-dose measurement taken on Day -1.
Primary	Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7	Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7	Fraction of inspired oxygen (FiO2) (percent) during the first 24 h and up to Day 7. Fraction of inspired oxygen (FiO2 \[percent\]). Results are shown as change from baseline, summarized at post-treatment time points. Definitions: FiO2=Fraction of inspired oxygen (percent); Baseline=The last pre-dose measurement taken on Day -1;
Primary	Number of Patients With Bronchopulmonary Dysplasia and Mortality	36 weeks post menstrual age, Day 14 Post-Natal Age, Day 28 Post-Natal Age	Bronchopulmonary dysplasia and mortality. Results summarize the following items: Number of patients who died and the number of patients who had bronchopulmonary dysplasia (BPD) were assessed by treatment, at 36 weeks post menstrual age (PMA). Number of patients who died by Day 28 post-natal age (PNA). Number of patients with respiratory distress syndrome (RDS)-associated mortality by Day 14 post-natal age (PNA). Definitions: BPD=Bronchopulmonary dysplasia; Mortality/BPD incidence=The incidence of neonates dead within 36-week PMA or alive at 36-week PMA with a diagnosis of BPD; PMA=Post menstrual age; PNA=Post-natal age; RDS=Respiratory distress syndrome;
Other	Number of Patients With Normal Breathing (Room Air) Within 24 Hours	Post-treatment up to 24 h	Normal breathing (room air) within 24 hours The number of patients with at least one reading of FiO2 equal to 21% (i.e. corresponding to room air for oxygen concentration) within 24 hours from first dose of surfactant was evaluated.
Other	Number of Patients With the Need for Re-dosing (Use of Rescue Surfactant)	Day 1 to Day 7	Number of patients with the need for re-dosing (use of rescue surfactant). The number of patients requiring at least one surfactant rescue dose (i.e. re-dosing with the study drug) at any time during the study was evaluated.
Other	Time to Reach Normal Breathing (Room Air) Within 24 Hours	Post-treatment Day 1: up to 24 h	Time to reach normal breathing (room air) within 24 hours. The median time to reach normal breathing (room air) within 24 hours from first dose of surfactant was evaluated. These are the patients who contributed to the results in the outcome measure 'Normal Breathing (room air) within 24 hours'.
Other	Concentration of Biomarkers of Inflammation in Tracheal Aspirates	Post-treatment Day 1 (24 h), Day 2 (48 h)	The inflammatory status of the patients was assessed (in a subgroup of babies who required endotracheal intubation for mechanical ventilation, when feasible). This was performed by measuring the concentration of specific biomarkers of inflammation in tracheal aspirates. The biomarkers measured were: Interleukin 1β, Interleukin 6, Interleukin 8, Myeloperoxidase, and Tumor Necrosis Factor-Alpha. The total protein content in tracheal aspirates was measured as an endogenous marker of dilution to calculate the extent to which epithelial lining fluid (ELF) was diluted during the tracheal aspirate procedure. To adjust for variation during the collection of tracheal aspirates, the measured cytokines values were normalized to the total protein. Results are presented as change from baseline in pg/mg total protein and were evaluated by descriptive statistics. Definition: Baseline=The last pre-dose measurement taken on Day -1;
Other	Immunogenicity: Assessment of Antibodies to Surfactant Protein B (SP-B) Analogue (CHF 5736.03) and to Surfactant Protein C (SP-C) Analogue (CHF 4902.03)	At approximately 5 weeks after the administration of study drug (with a range from 3 to 6 weeks).	Immunogenicity was assessed by measuring antibodies to SP-B analogue (CHF 5736.03) and to SP-C analogue (CHF 4902.03), contained in CHF 5633. Results are expressed as the titre (i.e. serum dilution) at which the sample had an absorbance of 0.069 (background) for SP-C Analogue (CHF 4902.03) CHF or an absorbance of 0.05 for SP-B Analogue (CHF 5736.03) in a microplate reader. The positive control serum was diluted in buffer solution and the maximum binding for the positive control was determined at dilutions \< 1/12.5 for SPC and \<1/100 for SPB. Test samples for immunogenicity were analyzed by using negative and positive controls. By definition, titer \<12.5 for CHF-4902.03 and \<100 for CHF-5736.02 show that the test serum had an absorbance equal to background at the same dilution at which the positive control had the maximum binding, implying absence of antibodies.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio	Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7	Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.	SpO2/FiO2 ratio	LEAST_SQUARES_MEAN
PRIMARY	Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7	Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7	Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.	Fraction of inspired oxygen (percent)	LEAST_SQUARES_MEAN
PRIMARY	Number of Patients With Bronchopulmonary Dysplasia and Mortality	36 weeks post menstrual age, Day 14 Post-Natal Age, Day 28 Post-Natal Age	Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Patients With Normal Breathing (Room Air) Within 24 Hours	Post-treatment up to 24 h	Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Patients With the Need for Re-dosing (Use of Rescue Surfactant)	Day 1 to Day 7	Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Time to Reach Normal Breathing (Room Air) Within 24 Hours	Post-treatment Day 1: up to 24 h	Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.	hour	MEDIAN
OTHER_PRE_SPECIFIED	Concentration of Biomarkers of Inflammation in Tracheal Aspirates	Post-treatment Day 1 (24 h), Day 2 (48 h)	Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.	pg/mg total protein	MEAN
OTHER_PRE_SPECIFIED	Immunogenicity: Assessment of Antibodies to Surfactant Protein B (SP-B) Analogue (CHF 5736.03) and to Surfactant Protein C (SP-C) Analogue (CHF 4902.03)	At approximately 5 weeks after the administration of study drug (with a range from 3 to 6 weeks).	Safety Population. All randomized patients who took at least one dose of study medication and who had the assessment done on 28 day PNA.	Titre (dilution with 0.050 absorbance)	NUMBER

Source ClinicalTrials.gov

Results by group88

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio	CHF5633	Day 1, 30 min	3.33	95% Confidence Interval 3.02 to 3.63	SpO2/FiO2 ratio
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio	Poractant Alfa	Day 1, 30 min	3.31	95% Confidence Interval 3.00 to 3.61	SpO2/FiO2 ratio
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio	CHF5633	Day 1, 1 h	3.36	95% Confidence Interval 3.07 to 3.66	SpO2/FiO2 ratio
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio	Poractant Alfa	Day 1, 1 h	3.55	95% Confidence Interval 3.26 to 3.84	SpO2/FiO2 ratio
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio	CHF5633	Day 1, 3 h	3.58	95% Confidence Interval 3.33 to 3.83	SpO2/FiO2 ratio
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio	Poractant Alfa	Day 1, 3 h	3.68	95% Confidence Interval 3.44 to 3.93	SpO2/FiO2 ratio
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio	CHF5633	Day 1, 6 h	3.77	95% Confidence Interval 3.52 to 4.02	SpO2/FiO2 ratio
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio	Poractant Alfa	Day 1, 6 h	3.87	95% Confidence Interval 3.63 to 4.12	SpO2/FiO2 ratio
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio	CHF5633	Day 1, 12 h	3.89	95% Confidence Interval 3.65 to 4.13	SpO2/FiO2 ratio
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio	Poractant Alfa	Day 1, 12 h	3.78	95% Confidence Interval 3.54 to 4.01	SpO2/FiO2 ratio

1 to 10 of 88Source ClinicalTrials.gov

See all 88 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	CHF5633	64
Overall Study	STARTED	Poractant Alfa	59
Overall Study	COMPLETED	CHF5633	53
Overall Study	COMPLETED	Poractant Alfa	49
Overall Study	NOT COMPLETED	CHF5633	11
Overall Study	NOT COMPLETED	Poractant Alfa	10

Source ClinicalTrials.gov

Adverse events232

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia neonatal	Blood and lymphatic system disorders	CHF5633	49	59	52
other	Anaemia neonatal	Blood and lymphatic system disorders	Poractant Alfa	47	58	50
other	Bandaemia	Blood and lymphatic system disorders	CHF5633	2	59	2
other	Bandaemia	Blood and lymphatic system disorders	Poractant Alfa	3	58	3
other	Leukocytosis	Blood and lymphatic system disorders	CHF5633	4	59	5
other	Leukocytosis	Blood and lymphatic system disorders	Poractant Alfa	7	58	7
other	Neutropenia neonatal	Blood and lymphatic system disorders	CHF5633	2	59	2
other	Neutropenia neonatal	Blood and lymphatic system disorders	Poractant Alfa	4	58	4
other	Thrombocytopenia neonatal	Blood and lymphatic system disorders	CHF5633	16	59	18
other	Thrombocytopenia neonatal	Blood and lymphatic system disorders	Poractant Alfa	16	58	17

1 to 10 of 232Source ClinicalTrials.gov

See all 232 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CHF5633	4	59
Total, all-cause mortality	Poractant Alfa	7	58
Total, other adverse events	CHF5633	59	59
Total, other adverse events	Poractant Alfa	58	58
Total, serious adverse events	CHF5633	20	59
Total, serious adverse events	Poractant Alfa	20	58

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32553868	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
CHF5633 vs Poractant Alfa: Number of Patients With Normal Breathing (Room Air) Within 24 Hours	Trial comparisons
CHF5633 vs Poractant Alfa: deaths from any cause	Trial comparisons
CHF5633 vs Poractant Alfa: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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