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NCT02187445 · ClinicalTrials.gov registry record · Phase 1
Inhaled Corticosteroid Use to Prevent Acute Chest Syndrome Recurrence in Children Between 1 and 4 With Sickle Cell Disease: a Feasibility Trial
A Phase 1 study of Asthma and Sickle Cell Disease, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT02187445: Completed Phase 1 study of Asthma and Sickle Cell Disease, sponsored by Vanderbilt University.
NCT02187445 is a Phase 1 study of Asthma and Sickle Cell Disease that has completed, run by Vanderbilt University. The registered enrollment target is 36 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02187445, a Phase 1 study of Asthma and Sickle Cell Disease, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Specific Aim 1: To determine the acceptability of budesonide inhalation suspension (BIS) 0.5 QD for 6 months for children with SCD that develop ACS between 1 and 4 years of age (n=10). We will determine the proportions of eligible families who were willing to participate and families that enrolled and elected to stay throughout the six months of the trial. We will also assess adherence to BIS using the Morisky scale; this will be our primary outcome. If the participation rate for the trial is le
Conditions Studied
Interventions
- DRUG Budesonide inhalation suspension
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-06 |
| Est. Completion | 2017-02-13 |
| Phase | Phase 1 |
What the finished NCT02187445 record still lists
NCT02187445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which Budesonide inhalation suspension is the first listed.
NCT02187445 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT02187445 about?
NCT02187445 is a clinical study titled "Inhaled Corticosteroid Use to Prevent Acute Chest Syndrome Recurrence in Children Between 1 and 4 With Sickle Cell Disease: a Feasibility Trial". 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 ...
What is the current status of trial NCT02187445?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2014-06. Estimated completion is 2017-02-13.
What conditions does trial NCT02187445 study?
This clinical trial studies the following conditions: Asthma, Sickle Cell Disease, Acute Chest Syndrome.
What interventions are being tested in trial NCT02187445?
The interventions under investigation include: Budesonide inhalation suspension (DRUG).
Who is sponsoring clinical trial NCT02187445?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02187445 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02187445's enrollment target sits among peer trials
36 287th of 374 higher than 83 of 374 other Asthma trials
participants (enrollment target), bucketed by value
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