The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room

NCT01524198 | Completed Phase 2 Results DMC

• 1 other identifier: 08-MED520-02
• Study Type: interventional
• Target: 945
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is the most common chronic illness of childhood. About 10% of children are affected. Not surprisingly, acute asthma exacerbations are one of the common reasons to visit pediatric emergency rooms (ER). About 5.7% of all pediatric emergency room visits are due to acute asthma exacerbation. Around 8% of those get admitted to the hospital. This constitutes huge financial and administrative burden on the health care system. Inhaled corticosteroids (ICS) is the gold standard prophylactic therapy for patients with persistent asthma. In the setting of acute asthma exacerbation systemic steroids given early in the course of treatment help decrease the rate of admission and return to the ER. However, the anti-inflammatory action of corticosteroids, through which this effect is caused, takes 4 hours to start working. This is because it is mediated through genomic pathways where the transcription of several inflammatory cytokines is suppressed. It was also shown that corticosteroids can cause vasoconstriction through non-genomic pathways. The onset of this action is as quick as 30-60 minutes. It is proposed that this action is mediated by blocking the extraneuronal uptake (metabolism) of norepinephrine in vascular smooth muscle cells, hence, making it available for re-use by the sympathetic neuronal cells. Our objective is to compare the efficacy of adding repetitive sequential doses of budesonide versus placebo (normal saline (NS)) to β2-agonist and ipratropium bromide (IB) combination (standard treatment) in the management of acute asthma in children in the ER. We hypothesize that the addition of budesonide to β2-agonist and IB in the management of moderate to severe acute asthma in the ER is superior to the addition of placebo.

Conditions

Status Asthmaticus

Outcome Measures

Primary Outcomes (1)

• Patients Hospitalization Rate

  The number of patients hospitalized over the study period (17 months).

  17 months

Secondary Outcomes (1)

• Change in Asthma Score From Baseline as Compared to the Score at Disposition

  2, 3, or 4 hours from baseline

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Subjects who are receiving normal saline (NS) in addition to Albuterol 2.5 mg if \< 20 kg or 5 mg if \>= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back

Drug: Normal saline

Budesonide

ACTIVE COMPARATOR

Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if \< 20 kg body weight or 5 mg if \>= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back

Drug: Budesonide

Interventions

Budesonide DRUG

500 mcg budesonide plus Albuterol plus ipratropium bromide (IB) nebulization, 3 doses back to back

Also known as: Pulmicort

Budesonide

Normal saline DRUG

0.5 ml to 1.5 ml normal saline (to complete 3 mls total volume), plus albuterol plus ipratropium bromide nebulizations 3 doses back to back

Normal Saline

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 2-12 years of age with physician diagnosed asthma or a previous episode of SOB that responded well to β2-agonists who present to the ER with moderate or severe asthma exacerbation

You may not qualify if:

• Children with mild asthma exacerbation.
• Children with severe asthma exacerbation who are in critical condition or need immediate intervention.
• Children who have heart disease or chronic lung disease other than asthma.
• Systemic steroids administered within the past 7 days.

Sponsors & Collaborators

• King Saud University: lead
• King Fahad Medical City: collaborator

Study Sites (1)

King Fahad Medical City

Riyadh, Riyadh Region, 11525, Saudi Arabia

Location

Related Publications (1)

• Alangari AA, Malhis N, Mubasher M, Al-Ghamedi N, Al-Tannir M, Riaz M, Umetsu DT, Al-Tamimi S. Budesonide nebulization added to systemic prednisolone in the treatment of acute asthma in children: a double-blind, randomized, controlled trial. Chest. 2014 Apr;145(4):772-778. doi: 10.1378/chest.13-2298.

  PMID: 24384609 DERIVED

MeSH Terms

Conditions

Status Asthmaticus

Interventions

Budesonide; Saline Solution

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Abdullah Alangari
• Organization: King Saud University

alangari100@gmail.com

966506287276

Study Officials

• Abdullah A Alangari, MBBS

  King Saud University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 1, 2012
• Study Start: November 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 13, 2014
• Results First Posted: February 13, 2014

Record last verified: 2014-02

Locations

SA (1)