Ideal Steroids for Asthma Treatment in the PICU

NCT03900624 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00187813
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Determine if differences in (1) pediatric intensive care unit length of stay, (2) continuous nebulized albuterol duration, and (3) a composite outcome of advanced asthma therapy incidence including use of non-invasive ventilation (NIV), terbutaline, inhaled helium and mechanical ventilation between cohorts of children admitted with status asthmaticus to the PICU treated with either IV dexamethasone (DM) or methylprednisolone (MP).

Conditions

Asthma Childhood

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  Hospital length of stay measured in days.

  From enrollment through hospital discharge, up to 1 week

Secondary Outcomes (1)

• Duration of Continuous Nebulized Albuterol

  From enrollment through hospital discharge, up to 1 week

Other Outcomes (2)

• Number of Participants Receiving an Adjunctive Asthma Therapy

  From enrollment through hospital discharge, up to 1 week

• Corticosteroid-related Adverse Events

  From enrollment through hospital discharge, up to 1 week

Study Arms (2)

Methylprednisolone Arm

NO INTERVENTION

Non-randomized, prospective, observational arm of children receiving standard care for status asthmaticus in the PICU with intravenous methylprednisolone.

Dexamethasone Arm

EXPERIMENTAL

Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticus

Dexamethasone Arm

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• children with existing tracheostomy, cystic fibrosis, and pulmonary hypertension

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Related Publications (9)

• Taylor IK, Shaw RJ. The mechanism of action of corticosteroids in asthma. Respir Med. 1993 May;87(4):261-77. doi: 10.1016/0954-6111(93)90022-r. No abstract available.

  PMID: 9728226 BACKGROUND

• Svedmyr N. Action of corticosteroids on beta-adrenergic receptors. Clinical aspects. Am Rev Respir Dis. 1990 Feb;141(2 Pt 2):S31-8.

  PMID: 1968733 BACKGROUND

• Scarfone RJ, Fuchs SM, Nager AL, Shane SA. Controlled trial of oral prednisone in the emergency department treatment of children with acute asthma. Pediatrics. 1993 Oct;92(4):513-8.

  PMID: 8414819 BACKGROUND

• Connett GJ, Warde C, Wooler E, Lenney W. Prednisolone and salbutamol in the hospital treatment of acute asthma. Arch Dis Child. 1994 Mar;70(3):170-3. doi: 10.1136/adc.70.3.170.

  PMID: 8135557 BACKGROUND

• Storr J, Barrell E, Barry W, Lenney W, Hatcher G. Effect of a single oral dose of prednisolone in acute childhood asthma. Lancet. 1987 Apr 18;1(8538):879-82. doi: 10.1016/s0140-6736(87)92857-1.

  PMID: 2882288 BACKGROUND

• Gleeson JG, Loftus BG, Price JF. Placebo controlled trial of systemic corticosteroids in acute childhood asthma. Acta Paediatr Scand. 1990 Nov;79(11):1052-8. doi: 10.1111/j.1651-2227.1990.tb11382.x.

  PMID: 2267922 BACKGROUND

• Kattan M, Gurwitz D, Levison H. Corticosteroids in status asthmaticus. J Pediatr. 1980 Mar;96(3 Pt 2):596-9. doi: 10.1016/s0022-3476(80)80872-9.

  PMID: 7359263 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

• Paniagua N, Lopez R, Munoz N, Tames M, Mojica E, Arana-Arri E, Mintegi S, Benito J. Randomized Trial of Dexamethasone Versus Prednisone for Children with Acute Asthma Exacerbations. J Pediatr. 2017 Dec;191:190-196.e1. doi: 10.1016/j.jpeds.2017.08.030.

  PMID: 29173304 BACKGROUND

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Anthony Sochet
• Organization: Johns Hopkins All Children's Hospital

Anthony.Sochet@jhmi.edu

7277672912

Study Officials

• Anthony A Sochet, MD, MS

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Single Arm Treatment Group with a Prospective, Comparative Cohort Receiving Standard Care

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: April 21, 2019
• Primary Completion: December 31, 2021
• Study Completion: May 15, 2022
• Last Updated: February 23, 2024
• Results First Posted: August 26, 2022

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)