Ignite Creation Date:
2024-05-06 @ 3:02 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02187445
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2014-06-27
Brief Title:
Inhaled Corticosteroid Use to Prevent Acute Chest Syndrome Recurrence in Children Between 1 and 4 With Sickle Cell Disease a Feasibility Trial
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Inhaled Corticosteroid Use to Prevent Acute Chest Syndrome Recurrence in Children Between 1 and 4 With Sickle Cell Disease a Feasibility Trial
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute and chronic pulmonary complications with concomitant inflammatory response are a leading cause of morbidity and mortality in children with sickle cell disease SCD Acute chest syndrome ACS defined broadly as an increase in respiratory effort fever and new radiodensity on chest x-ray is a major cause of death in children and adults with SCD There is a high rate of ACS in children between 1 and 4 years of age that is associated with an asthma diagnosis and children with ACS events before 4 years of age have a 50 rate of being hospitalized for either ACS or pain within 1 year of admission For children with SCD that develop ACS the investigators propose that the use of budesonide inhalation suspension BIS will attenuate pulmonary inflammation after an ACS episode and will decrease future vaso-occlusive pain and ACS episodes Through a single-arm prospective feasibility trial and in preparation for a limited-institution randomized trial the investigators plan to test the following primary hypothesis for a phase III definitive trial In children with SCD admitted to the hospital for an ACS episode between 1 and 4 years of age low dose BIS for 6 months will result in a 50 reduction in the recurrent incidence rate of ACS or pain requiring hospitalization Through this trial the investigators will determine the acceptability of and adherence to BIS in the study population The investigators will track respiratory symptoms in cases versus controls over 6 months Finally the investigators will explore the impact of BIS on biological correlates sVCAM-1
Detailed Description:
None
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