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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 : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Asthma is the most common chronic disease of children. A short (3-5 day) course of a short-acting steroid such as Prednisone or Prednisolone has long been the standard of care for asthma exacerbation. Dexamethasone efficacy in asthma exacerbation has been studied in the outpatient setting and was found to be as effective as Prednisone. Dexamethasone has the advantage of shorter course, more compliance, and more tolerable. This has led many emergency departments to provide a 1-2 dose course of Dexamethasone on discharge. Thus, many inpatients have received a first dose of Dexamethasone prior to reaching the inpatient unit, leading to confusion about the best plan for these patients. Many hospitalist pediatricians continue to give a 5-day total course with Prednisone, but some patients have begun to receive a second dose of Dexamethasone 24 hours after the first dose. To our knowledge, no studies have been done to compare the efficacy of these two protocols in pediatric patients requiring hospitalization. The hypothesis is that a second dose of Dexamethasone is as effective as four additional days of Prednisone in hospitalized children with asthma exacerbation. This is an open label, randomized control study comparing these treatments in children age 2-18 hospitalized with asthma exacerbation who have received a first dose of Dexamethasone.

Condition or disease Intervention/treatment Phase
Asthma Status Asthmaticus Wheezes Drug: Dexamethasone Drug: Prednisone Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Dexamethasone
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.
Drug: Dexamethasone
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.
Drug: Prednisone
at 24 hours from the first Dexamethasone dose given in ED.
Other Name: Orapred




Primary Outcome Measures :
  1. Return to normal activity (Patient Self-Assessment Score) [ Time Frame: 3 days after discharge ]
    Proportion of patients who have returned to normal activity


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Admission to PICU
  • Recent steroid use (within 1 month)
  • Cardiac disorder, chronic respiratory illness (BPD or CF)
  • Stridor
  • Bacterial Pneumonia

Information from the National Library of Medicine

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


Locations
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United States, Florida
Wolfson Children Hospital
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Jeffrey C Winer, MD Universiry of Florida, College of medicine Jacksonville

Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02780479     History of Changes
Other Study ID Numbers: UFJ 2016-24
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Prednisone
Dexamethasone
Asthma exacerbation
Hospitalized

Additional relevant MeSH terms:
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Asthma
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Prednisone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action