Status Asthmaticus on the PICU; Intravenous Salbutamol (STATIC IV)

Efficacy of a Loading Dose of IV Salbutamol in Children Admitted to a PICU for Severe Acute Asthma or Severe Acute Wheeze

Although IV salbutamol is frequently used in children in a wide range, pharmacodynamic data are scarce. To date, there is an insufficient evidence base to guide initial and subsequent dosing recommendation for its IV use in children. Especially the need for a loading dose needs to be addressed. Therefore, pharmacodynamic and kinetic data are needed to guide initial dosing strategies of IV salbutamol in children. To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the loading dose, compared to placebo.

Study Overview

• Status: Completed
• Conditions: Childhood Asthma With Status Asthmaticus
• Intervention / Treatment: Drug: Salbutamol; Drug: Sodium Chloride 0.9%

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3000WB
      • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Between 2-18 years of age at moment of inclusion
• Admitted to PICU for Severe Acute Asthma or Severe acute (viral) wheeze
• Requiring administration of IV salbutamol

Exclusion Criteria:

• Patient is outside of specified age range
• Patient has already received a -loading dose- of IV salbutamol in the general hospital
• Lower airway infection with consolidation on a chest X ray -Patient has Down's Syndrome
• Patient has a congenital/acquired heart defect that interferes with normal asthma treatment
• Patient has a primary/secondary immunodeficiency
• Patient has a pre-existing chronic pulmonary condition, known to mimic asthma: Cystic fibrosis, Bronchopulmonary dysplasia, Bronchiolitis obliterans

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Salbutamol loading dose; Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg.	Drug: Salbutamol; Intravenous Salbutamol loading dose
PLACEBO_COMPARATOR: Sodium Chloride 0.9%; 10 ml of Sodium Chloride 0.9% in 10 minutes.	Drug: Sodium Chloride 0.9%; 10 ml of Sodium Chloride 0.9% in 10 minutes intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction Asthma score	The primary outcome variable is (reduction of) asthma score (Qureshi) 1 hour after administration of loading dose in the intervention group compared to the placebo group. Based on expert opinion, we consider a reduction of 2 points to represent a clinically relevant improvement.	First 24 hours after admission on the PICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative dose of IV salbutamol		Through study completion, an average 48 hours
Maximum infusion rate of IV salbutamol in mcg/kg/min		Through study completion, an average 48 hours
Total duration of IV salbutamol treatment in hours		Through study completion, an average 48 hours
Occurrence/frequency of side effects		Through study completion, an average 48 hours
Length of Stay on PICU in days		Through study completion, an average 72 hours
Use of co-medication		Through study completion, an average 72 hours
Use of/duration of non-invasive mechanical ventilation in days		Through study completion, an average 72 hours
DNA polymorphism of the ADRB2-receptor gene	The investigators will look at DNA, if there is a polymorphism in the ADRB2-receptor gene. If there is a polymorphism it can cause downregulation of the adrenergic B2 receptors.	Through study completion, an average 1 year
Use of/duration of non-invasive/invasive mechanical ventilation in days		Through study completion, an average 72 hours

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 5, 2017
• Primary Completion (ACTUAL): May 21, 2019
• Study Completion (ACTUAL): May 21, 2019

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (ACTUAL): April 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Status Asthmaticus; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: NL55029.078.16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No