A Phase 4 interventional study of Salbutamol and Sodium Chloride 0.9% in Childhood Asthma With Status Asthmaticus, sponsored by Erasmus Medical Center. Completed at 1 site in Netherlands. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-07-30.
Sponsored by Erasmus Medical Center · Phase 4, Interventional, and Treatment
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.
35 studies on the registry are indexed under Status Asthmaticus; 1 is open to participants now.
This study's enrollment of 58 is above the median of 51 across 24 interventional studies indexed under Status Asthmaticus.
Browse Status Asthmaticus studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
Compared within Status Asthmaticus, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Asthma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg.
Drug: Salbutamol
10 ml of Sodium Chloride 0.9% in 10 minutes.
Drug: Sodium Chloride 0.9%
Intravenous Salbutamol loading dose
10 ml of Sodium Chloride 0.9% in 10 minutes intravenous
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.
Time frame: First 24 hours after admission on the PICU
Cumulative dose of IV salbutamol
Time frame: Through study completion, an average 48 hours
Maximum infusion rate of IV salbutamol in mcg/kg/min
Time frame: Through study completion, an average 48 hours
Total duration of IV salbutamol treatment in hours
Time frame: Through study completion, an average 48 hours
Occurrence/frequency of side effects
Time frame: Through study completion, an average 48 hours
Length of Stay on PICU in days
Time frame: Through study completion, an average 72 hours
Use of co-medication
Time frame: Through study completion, an average 72 hours
Use of/duration of non-invasive mechanical ventilation in days
Time frame: 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.
Time frame: Through study completion, an average 1 year
Use of/duration of non-invasive/invasive mechanical ventilation in days
Time frame: Through study completion, an average 72 hours
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Albuterol