First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome

Respiratory Distress Syndrome in Premature Infants Clinical Trial

Official title:

A First in Human Clinical Study on the Safety and Tolerability of Two Escalating Single Doses of CHF 5633 (Synthetic Surfactant) in Preterm Neonates With Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651637
• Other study ID #: CCD-1011-PR-0059
• Status: Completed
• Phase: Phase 1
• Start date: October 2012
• Est. completion date: January 23, 2015

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the safety and tolerability of intratracheal administration of two different single doses of CHF 5633 in preterm neonates with RDS in terms of adverse events, adverse drug reactions, hematology and biochemistry values, the incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and mortality.

Description:

The study will be a multicentre, open-label, single escalating dose, per-cohort design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 23, 2015
• Est. primary completion date: January 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 27 Weeks to 34 Weeks

Eligibility

Inclusion Criteria:

• Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures

• Inborn and outborn, preterm neonates of either sex with a gestational age of 27 weeks up to 33 weeks+6

• Clinical and radiological findings typical of RDS

• Age on admission to the study < 24 hours from birth

• Requirement of endotracheal intubation for surfactant administration

• Fraction of inspired oxygen (FiO2) > 0.35 to maintain SpO2 between 90-95 %

• Documentation of normal cranial ultrasound scan

Exclusion Criteria:

• Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)

• Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)

• Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy

• Clinical chorioamnionitis (Appendix III)

• Strong suspicion of congenital pneumonia/infection, sepsis

• Evidence of severe birth asphyxia or a 5 minutes Apgar score less / equal 3

• Presence of air leaks prior to study entry

• Neonatal seizures prior to study entry

• Mothers with prolonged rupture of the membranes (> 3 weeks duration)

• Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

• Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol

Related Conditions & MeSH terms

• Respiratory Distress Syndrome in Premature Infants
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• synthetic surfactant (CHF5633)
CHF5633 100 mg/kg; CHF5633 200 mg/kg synthetic surfactant sterile suspension in 3.0 ml glass vials with a total concentration of 80 mg/ml for intratracheal administration. Single administration

Locations

Country	Name	City	State
United Kingdom	Liverpool Women's Hospital Neonatal Unit Liverpool Women's Hospital	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Sweet DG, Turner MA, Stranák Z, Plavka R, Clarke P, Stenson BJ, Singer D, Goelz R, Fabbri L, Varoli G, Piccinno A, Santoro D, Speer CP. A first-in-human clinical study of a new SP-B and SP-C enriched synthetic surfactant (CHF5633) in preterm babies with r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitoring of adverse events following CHF5633 administration		For duration of hospital stay (expected average of 9 weeks)
Secondary	CHF 5633 efficacy profile (oxygenation , ventilatory requirements and need for rescue surfactant treatment),systemic absorption and immunogenicity assesment		At min 30, at hrs 1, 3, 6, 12, 24, at days 2, 3, 7 and at days 10, 28, at 36 weeks pma post dosing for ventilatory requirements, at pre-dose and 3 hrs and 24 hrs post dosing for systemic absorption and at 8 wks after administration for immunogenicity

External Links

•   Study Record on EU Clinical Trials Register including results