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Generated: February 17, 2019

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CLINICAL TRIALS PROFILE FOR CUROSURF

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Clinical Trials for Curosurf

Trial ID Title Status Sponsor Phase Summary
NCT00501982 Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study Completed Chiesi Farmaceutici S.p.A. Phase 4 The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS: 1. Early stabilization on nCPAP 2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP. The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.
NCT00767039 Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants Terminated Dey LP Phase 4 Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.
NCT00767039 Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants Terminated Alan Fujii Phase 4 Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.
NCT01243996 High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant Completed University of Florence Phase 2/Phase 3 The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher than those actually recommended might increase the closure rate in preterm infants with gestational age <29 weeks without increasing the occurrence of associated adverse effects. To assess this hypothesis the investigators planned a multicenter randomized controlled study to compare the effectiveness of the current ibuprofen regimen to that of a high-dose regimen in closing PDA.
NCT01537354 Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome Withdrawn Cornerstone Pharmaceuticals, Inc. N/A This is a null hypothesis study. The investigators hypothesize that there will be no difference in changes in dynamic compliance when measured at 15, 30, 45 and 60 minute intervals after administration of either surfactant and there will be no differences in the number of doses needed between the two surfactants in premature infants admitted to our NICU.
NCT01537354 Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome Withdrawn University of Michigan N/A This is a null hypothesis study. The investigators hypothesize that there will be no difference in changes in dynamic compliance when measured at 15, 30, 45 and 60 minute intervals after administration of either surfactant and there will be no differences in the number of doses needed between the two surfactants in premature infants admitted to our NICU.
NCT01709409 A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants Completed Ottawa Hospital Research Institute Phase 3 The purpose of this study is to see if a medication called Curosurf can reduce the length of time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS, stay on the ventilator, as compared to the standard medication called BLES. Curosurf is a medication that is already used in other countries around the world but not yet in Canada. Babies born under 32 weeks of gestation frequently need respiratory support after birth, including being placed on a breathing machine or respirator. The most common reason is Respiratory Distress Syndrome (RDS) whereby immature lungs don't produce enough surfactant, a soapy like substance that helps the air sacs open and close. Our current standard treatment is a surfactant called BLES. Curosurf contains more active ingredient per volume therefore the amount is smaller. The investigators hypothesize that babies who receive Curosurf will be able to be removed from the ventilator sooner. Babies in this study will have a 50/50 chance of receiving either Curosurf or BLES and the investigators will monitor their progress during their Neonatal Intensive Care Unit admission. The study is taking place in Canada. The goal is to enroll 88 babies. There are no extra tests (blood tests or X-Rays) or return visits to the hospital for the purposes of this study.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Curosurf

Condition Name

Condition Name for Curosurf
Intervention Trials
Respiratory Distress Syndrome 9
Respiratory Distress Syndrome, Newborn 3
Bronchopulmonary Dysplasia 2
Neonatal Respiratory Distress Syndrome 1
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Condition MeSH

Condition MeSH for Curosurf
Intervention Trials
Respiratory Distress Syndrome, Newborn 13
Respiratory Distress Syndrome, Adult 13
Syndrome 10
Ductus Arteriosus, Patent 2
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Clinical Trial Locations for Curosurf

Trials by Country

Trials by Country for Curosurf
Location Trials
Italy 9
United States 5
China 1
France 1
Spain 1
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Trials by US State

Trials by US State for Curosurf
Location Trials
Missouri 1
Oklahoma 1
Georgia 1
Michigan 1
Massachusetts 1
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Clinical Trial Progress for Curosurf

Clinical Trial Phase

Clinical Trial Phase for Curosurf
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Curosurf
Clinical Trial Phase Trials
Completed 5
Recruiting 4
Not yet recruiting 3
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Clinical Trial Sponsors for Curosurf

Sponsor Name

Sponsor Name for Curosurf
Sponsor Trials
Chiesi Farmaceutici S.p.A. 4
Chung Shan Medical University 1
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 1
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Sponsor Type

Sponsor Type for Curosurf
Sponsor Trials
Other 27
Industry 7
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McKesson
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US Army
Johnson and Johnson
Accenture
Cantor Fitzgerald
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Boehringer Ingelheim
Mallinckrodt

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