Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589245
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Inhaled Ciclesonide Study in Preterm Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Safety and Toxicity of Inhaled Ciclesonide ie Alvesco in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our overall objective is to conduct a safety study with inhaled ciclesonide to evaluate known glucocorticoids sGC-related acute and intermediate toxic effects while measuring for the first time in neonates its systemic absorption and potential bioactivity ie activation of primary target the GR in blood cells
Detailed Description:
Preterm infants born before 30 weeks gestation are at increased risk of developing bronchopulmonary dysplasia BPD a leading cause of death and long-term pulmonary insufficiency Both hydrocortisone and synthetic glucocorticoids sGC are commonly used to prevent BPD in premature infants Clinical trials have shown that hydrocortisone targeted to infants with emerging lung disease does not prevent BPD while inhaled sGC therapy has shown mixed efficacy in clinical trials Dexamethasone DEX has been shown in clinical trials to reduce BPD rates in premature infants but is associated with short term and long-term adverse effects including cerebral palsy There is an unmet need for efficacious Glucocorticoid GC therapy in premature infants to prevent BPD without encumbering serious adverse events To address this challenge our group has been investigating ciclesonide CIC a sGC pro-drug that in the inhaled form is FDA approved for use in asthma and allergic rhinitis in older children Our published and ongoing work has shown that DEX and CIC regulate GR transcriptional targets and several genes implicated in lung protective effects in neonatal rats Remarkably CIC does not suppress somatic growth nor IGF-1 levels induce hyperglycemia or cause neuroanatomical changes in the cerebral cortex of neonatal rats which are known pathologies caused by DEX in premature infants Furthermore ongoing studies reveal that CIC is as efficacious as DEX in preventing lung injury in a hyperoxia-model of experimental BPD This study tests the hypothesis that CIC will have minimal systemic absorption and a favorable safety profile in premature infants at risk of developing BPD
The fear of long-term neurological adverse effects has limited optimal use of sGC therapy to prevent BPD This application is significant as it proposes to repurpose CIC an existing sGC for novel therapeutic use in preterm infants to prevent BPD CIC is already FDA-approved for use in children 5 years for allergic rhinitis and asthma and can be used on a compassionate basis down to 2 years of age The investigators believe our study is impactful and translationally relevant as it addresses an unmet need for efficacious GC therapy to prevent BPD in premature infants without encumbering the neurological and somatic adverse effects Successful testing of our hypothesis will pave the way for a large multicenter randomized control trial of CIC therapy in premature infants to prevent BPD
The fear of long-term neurological adverse effects has limited optimal use of sGC therapy to prevent BPD This application is significant as it proposes to repurpose CIC an existing sGC for novel therapeutic use in preterm infants to prevent BPD CIC is already FDA-approved for use in children 5 years for allergic rhinitis and asthma and can be used on a compassionate basis down to 2 years of age The investigators believe our study is impactful and translationally relevant as it addresses an unmet need for efficacious GC therapy to prevent BPD in premature infants without encumbering the neurological and somatic adverse effects Successful testing of our hypothesis will pave the way for a large multicenter randomized control trial of CIC therapy in premature infants to prevent BPD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None