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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01651637
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : July 31, 2020
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome in Premature Infants Drug: synthetic surfactant (CHF5633) Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2012
Actual Primary Completion Date : January 23, 2015
Actual Study Completion Date : January 23, 2015

Arm Intervention/treatment
Experimental: Synthetic Surfactant
Cohort Design
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

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   27 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01651637

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United Kingdom
Liverpool Women's Hospital Neonatal Unit Liverpool Women's Hospital
Liverpool, United Kingdom
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
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Principal Investigator: Christian Speer, MD Universitäts-Kinderklinik Würzburg (Germany)
Additional Information:
Publications of Results:
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Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT01651637    
Other Study ID Numbers: CCD-1011-PR-0059
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chiesi Farmaceutici S.p.A.:
Respiratory Distress syndrome
Complications of prematurity
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents