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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Syn

Brief 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.

Detailed Summary: The study will be a multicentre, open-label, single escalating dose, per-cohort design.
Sponsor: Chiesi Farmaceutici S.p.A.

Current Primary Outcome: Monitoring of adverse events following CHF5633 administration [ Time Frame: For duration of hospital stay (expected average of 9 weeks) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: CHF 5633 efficacy profile (oxygenation , ventilatory requirements and need for rescue surfactant treatment),systemic absorption and immunogenicity assesment [ Time Frame: 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 ]

Original Secondary Outcome: Same as current

Information By: Chiesi Farmaceutici S.p.A.

Dates:
Date Received: April 20, 2012
Date Started: October 2012
Date Completion:
Last Updated: March 28, 2017
Last Verified: March 2017