Steroids in Children Hospitalized With Asthma

NCT02780479 | Terminated Phase 4

• 1 other identifier: UFJ 2016-24
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Status Asthmaticus; Wheezes

Keywords

Prednisone; Dexamethasone; Asthma exacerbation; Hospitalized

Outcome Measures

Primary Outcomes (1)

• Return to normal activity (Patient Self-Assessment Score)

  Proportion of patients who have returned to normal activity

  3 days after discharge

Secondary Outcomes (3)

• Relapse ( ED visit or unscheduled physician visit)

  2 weeks after discharge

• Albuterol use (Patient Self-Assessment Score)

  2 weeks after discharge

• Asthma symptoms (Patient Self-Assessment Score)

  2 weeks after discharge

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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

Prednisone

ACTIVE COMPARATOR

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

Interventions

Dexamethasone DRUG

at 24 hours from the first Dexamethasone dose given in ED.

Also known as: Decadron

Dexamethasone

Prednisone DRUG

at 24 hours from the first Dexamethasone dose given in ED.

Also known as: Orapred

Prednisone

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Wolfson Children Hospital

Jacksonville, Florida, 32207, United States

Location

Related Publications (12)

• National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.

  PMID: 17983880 BACKGROUND

• Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014 Mar;133(3):493-9. doi: 10.1542/peds.2013-2273. Epub 2014 Feb 10.

  PMID: 24515516 BACKGROUND

• Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001 Jul;139(1):20-6. doi: 10.1067/mpd.2001.115021.

  PMID: 11445789 BACKGROUND

• Rowe BH, Spooner CH, Ducharme FM, Bretzlaff JA, Bota GW. Corticosteroids for preventing relapse following acute exacerbations of asthma. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD000195. doi: 10.1002/14651858.CD000195.pub2.

  PMID: 17636617 BACKGROUND

• Butler K, Cooper WO. Adherence of pediatric asthma patients with oral corticosteroid prescriptions following pediatric emergency department visit or hospitalization. Pediatr Emerg Care. 2004 Nov;20(11):730-5. doi: 10.1097/01.pec.0000144914.78124.6f.

  PMID: 15502653 BACKGROUND

• Czock D, Keller F, Rasche FM, Haussler U. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44(1):61-98. doi: 10.2165/00003088-200544010-00003.

  PMID: 15634032 BACKGROUND

• Gries DM, Moffitt DR, Pulos E, Carter ER. A single dose of intramuscularly administered dexamethasone acetate is as effective as oral prednisone to treat asthma exacerbations in young children. J Pediatr. 2000 Mar;136(3):298-303. doi: 10.1067/mpd.2000.103353.

  PMID: 10700684 BACKGROUND

• Klig JE, Hodge D 3rd, Rutherford MW. Symptomatic improvement following emergency department management of asthma: a pilot study of intramuscular dexamethasone versus oral prednisone. J Asthma. 1997;34(5):419-25. doi: 10.3109/02770909709055384.

  PMID: 9350159 BACKGROUND

• Gordon S, Tompkins T, Dayan PS. Randomized trial of single-dose intramuscular dexamethasone compared with prednisolone for children with acute asthma. Pediatr Emerg Care. 2007 Aug;23(8):521-7. doi: 10.1097/PEC.0b013e318128f821.

  PMID: 17726409 BACKGROUND

• Altamimi S, Robertson G, Jastaniah W, Davey A, Dehghani N, Chen R, Leung K, Colbourne M. Single-dose oral dexamethasone in the emergency management of children with exacerbations of mild to moderate asthma. Pediatr Emerg Care. 2006 Dec;22(12):786-93. doi: 10.1097/01.pec.0000248683.09895.08.

  PMID: 17198210 BACKGROUND

• Greenberg RA, Kerby G, Roosevelt GE. A comparison of oral dexamethasone with oral prednisone in pediatric asthma exacerbations treated in the emergency department. Clin Pediatr (Phila). 2008 Oct;47(8):817-23. doi: 10.1177/0009922808316988. Epub 2008 May 8.

  PMID: 18467673 BACKGROUND

• National Asthma Education and Prevention Program. National Asthma Education and Prevention Program. Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma Update on Selected Topics--2002. J Allergy Clin Immunol. 2002 Nov;110(5 Suppl):S141-219. No abstract available.

  PMID: 12542074 BACKGROUND

MeSH Terms

Conditions

Asthma; Status Asthmaticus; Respiratory Sounds

Interventions

Dexamethasone; Calcium Dobesilate; Prednisone; Methylprednisolone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienediols; Prednisolone

Study Officials

• Jeffrey C Winer, MD

  Universiry of Florida, College of Medicine Jacksonville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 23, 2016
• Study Start: March 20, 2017
• Primary Completion: August 29, 2017
• Study Completion: August 29, 2017
• Last Updated: June 21, 2019

Record last verified: 2019-06

Locations

US (1)