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

Study Identifier:
CCD-1011-PR-0059
ClinicalTrials.gov Identifier:
NCT01651637
EudraCT Identifier:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Study Details

Medical Condition
  • Neonatal Respiratory Distress Syndrome
Study Drug
  • Drug: synthetic surfactant (CHF5633)
Date
Oct 2012 - Jan 2015
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 27 - 34 Weeks
Requirements Information
Healthy Volunteers
No

Protocol 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.

Study Locations

Location
Status
Location
Liverpool Women's Hospital Neonatal Unit Liverpool Women's Hospital
Liverpool, United Kingdom
Status
N/A

Study Publications

Sweet DG, Turner MA, Stranak 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 respiratory distress syndrome. Arch Dis Child Fetal Neonatal Ed. 2017 Nov;102(6):F497-F503. doi: 10.1136/archdischild-2017-312722. Epub 2017 May 2.