Steroids in Children Hospitalized With Asthma
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|ClinicalTrials.gov Identifier: NCT02780479|
Recruitment Status : Terminated (insufficient number of participants met the enrollment criteria.)
First Posted : May 23, 2016
Last Update Posted : June 21, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Asthma Status Asthmaticus Wheezes||Drug: Dexamethasone Drug: Prednisone||Phase 4|
Corticosteroids are the first-line therapy for managing acute asthma exacerbations. Studies have shown that systemic steroids effect decrease relapse and hospital admission. Due to its short half-life, Prednisone is usually given daily or twice daily for 3-5 days. It has been associated with poor compliance due it the prolonged course. Dexamethasone half-life is 36 - 72 hours.
Several studies have shown no difference in outcomes between 3-5 days of prednisone and different forms of dexamethasone, including single intramuscular dose or single oral dose or two oral doses 1 day apart. However, those studies were done in the emergency department (ED). Lack of response to initial asthma treatment in ED results in admission to the hospital, implying more severe exacerbation than those able to be discharged. Some clinician shift to oral prednisone once admitted to the floor for patients who have received Dexamethasone or not. Others have begin to complete the Dexamethasone course with one more dose of Dexamethasone 24 hour after the first dose. Dexamethasone has the advantage of compliance and tolerability, however, no studies investigated its efficacy in hospitalized patients. Such knowledge will improve patient's compliance and outcomes.
- Sample size calculation: Primary outcome of return to normal activities within 3 days of discharge. Based on previous studies, it is estimated that 70% of the control group will achieve this goal. Based on a minimum absolute difference of 15%, and a power of 0.80, the sample size calculated to be 117 in each arm. Assuming 20% lost to follow up, it is intended to recruit 150 in each arm (total 300 subjects).
- Statistical Analysis: Demographics will be analyzed to ensure the experimental and control groups are equivalent at baseline. All proportions will be tested with Chi-square or Fisher exact test and two-sample T-test will be used for continuous variables. α = 0.05 will be used for all hypothesis tests. Interim analysis will be performed monthly and the study will be halted if any safety concerns arise. The Center for Health Equity and Quality Research (CHEQR) will help with statistical analysis
- Data Safety and Monitoring Plan: The study PI and co-investigator will meet and review the collected data on a monthly basis and identify any interim results that may require a change of study protocol. Information that may affect subjects' safety will be communicated to appropriate parties in a timely fashion.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Dexamethasone Versus Oral Prednisone in Children Hospitalized With Asthma: A Randomized Control Study|
|Actual Study Start Date :||March 20, 2017|
|Actual Primary Completion Date :||August 29, 2017|
|Actual Study Completion Date :||August 29, 2017|
Dexamethasone arm: will receive second dose of oral Dexamethasone 0.6 mg/kg/dose max of 16 mg, 24 hour from the first dose given in emergency department.
at 24 hours from the first Dexamethasone dose given in ED.
Other Name: Decadron
Active Comparator: Prednisone
Prednisone arm: will receive oral Prednisone 1mg/kg with max of 30 mg twice daily starting 24 hours after the Dexamethasone dose given in emergency department for 8 additional doses.
at 24 hours from the first Dexamethasone dose given in ED.
Other Name: Orapred
- Return to normal activity (Patient Self-Assessment Score) [ Time Frame: 3 days after discharge ]Proportion of patients who have returned to normal activity
- Relapse ( ED visit or unscheduled physician visit) [ Time Frame: 2 weeks after discharge ]Proportion of patients with unscheduled primary care physician visits, emergency department or hospital admission
- Albuterol use (Patient Self-Assessment Score) [ Time Frame: 2 weeks after discharge ]Proportion of patients with of ongoing albuterol use (based on validated self-reporting tool)
- Asthma symptoms (Patient Self-Assessment Score) [ Time Frame: 2 weeks after discharge ]Patient self assessment score at 2 weeks after discharge
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|Ages Eligible for Study:||2 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Signed informed consent by legal guardian
- Age 2 to 18 years old
- Admission to the floor with acute asthma exacerbation.
- Received single dose of oral Dexamethasone
- Initial Pediatric Asthma Score (PAS) of 8 or higher.
- Admission to PICU
- Recent steroid use (within 1 month)
- Cardiac disorder, chronic respiratory illness (BPD or CF)
- Bacterial Pneumonia
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 ClinicalTrials.gov identifier (NCT number): NCT02780479
|United States, Florida|
|Wolfson Children Hospital|
|Jacksonville, Florida, United States, 32207|
|Principal Investigator:||Jeffrey C Winer, MD||Universiry of Florida, College of Medicine Jacksonville|
|Responsible Party:||University of Florida|
|Other Study ID Numbers:||
|First Posted:||May 23, 2016 Key Record Dates|
|Last Update Posted:||June 21, 2019|
|Last Verified:||June 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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