Back to resultsStatus Asthmaticus on the PICU; Intravenous Salbutamol (STATIC IV)
Primary Purpose
Childhood Asthma With Status Asthmaticus
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Salbutamol
Sodium Chloride 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Asthma With Status Asthmaticus
Eligibility Criteria
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
Sites / Locations
- Erasmus MC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Salbutamol loading dose
Sodium Chloride 0.9%
Arm Description
Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg.
10 ml of Sodium Chloride 0.9% in 10 minutes.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cumulative dose of IV salbutamol
Maximum infusion rate of IV salbutamol in mcg/kg/min
Total duration of IV salbutamol treatment in hours
Occurrence/frequency of side effects
Length of Stay on PICU in days
Use of co-medication
Use of/duration of non-invasive mechanical ventilation in days
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.
Use of/duration of non-invasive/invasive mechanical ventilation in days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03493503
Brief Title
Status Asthmaticus on the PICU; Intravenous Salbutamol
Acronym
STATIC IV
Official Title
Efficacy of a Loading Dose of IV Salbutamol in Children Admitted to a PICU for Severe Acute Asthma or Severe Acute Wheeze
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
May 21, 2019 (Actual)
Study Completion Date
May 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Asthma With Status Asthmaticus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salbutamol loading dose
Arm Type
Experimental
Arm Description
Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg.
Arm Title
Sodium Chloride 0.9%
Arm Type
Placebo Comparator
Arm Description
10 ml of Sodium Chloride 0.9% in 10 minutes.
Intervention Type
Drug
Intervention Name(s)
Salbutamol
Intervention Description
Intravenous Salbutamol loading dose
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 0.9%
Intervention Description
10 ml of Sodium Chloride 0.9% in 10 minutes intravenous
Primary Outcome Measure Information:
Title
Reduction Asthma score
Description
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
Secondary Outcome Measure Information:
Title
Cumulative dose of IV salbutamol
Time Frame
Through study completion, an average 48 hours
Title
Maximum infusion rate of IV salbutamol in mcg/kg/min
Time Frame
Through study completion, an average 48 hours
Title
Total duration of IV salbutamol treatment in hours
Time Frame
Through study completion, an average 48 hours
Title
Occurrence/frequency of side effects
Time Frame
Through study completion, an average 48 hours
Title
Length of Stay on PICU in days
Time Frame
Through study completion, an average 72 hours
Title
Use of co-medication
Time Frame
Through study completion, an average 72 hours
Title
Use of/duration of non-invasive mechanical ventilation in days
Time Frame
Through study completion, an average 72 hours
Title
DNA polymorphism of the ADRB2-receptor gene
Description
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
Title
Use of/duration of non-invasive/invasive mechanical ventilation in days
Time Frame
Through study completion, an average 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3000WB
Country
Netherlands
12. IPD Sharing Statement
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Status Asthmaticus on the PICU; Intravenous Salbutamol
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