Study to look at the usefulness of an extra dose of salbutamol (medicine that widens the airways in the lungs) through the bloodstream, in children who are admitted to an intensive care for a very severe asthma-attack.

STATIC IV: Efficacy of a loading dose of intravenous salbutamol in patients admitted to a PICU for severe acute asthma - STATIC IV: STATus asthmaticus on the paediatric Intensive Care - IntraVenous salbutamol

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003551-22-NL

Enrollment

Unknown

Registered

2016-06-27

Start date

2016-12-28

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe acute (viral) wheeze and severe acute asthma MedDRA version: 19.0 Level: LLT Classification code 10047921 Term: Wheeze System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.0 Level: PT Classification code 10041961 Term: Status asthmaticus System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Ventolin Infuus, oplossing voor injectie 0,5 mg/ml Product Name: Ventolin Infuus, oplossing voor injectie 0,5 mg/ml Pharmaceutical Form: Solution for injection Pharmaceutical form of the p

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? yes Number of subjects for this age range: 52 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To assess the following pharmacodynamics parameters of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. -Maximum rate and duration of infusion of IV salbutamol -Total (cumulative) dose of IV salbutamol -Length of stay on PICU -Need for other medication (e.g. sodium bicarbonate, theophyllin, sevoflurane) -Need for non-invasive/invasive mechanical ventilation (+ duration) -Frequency of side effects (Tachycardia, Arrhythmia, Hypotension, Hypokalaemia, Hyperglycaemia, Lactic acidosis) -Distribution of ADBR2 receptor polymorphisms ;Main Objective: 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.;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: 1 hour after administration of loading dose of IV salbutamol	—

Measure

Time frame

Secondary Objective: To assess the following pharmacodynamics parameters of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. -Maximum rate and duration of infusion of IV salbutamol -Total (cumulative) dose of IV salbutamol -Length of stay on PICU -Need for other medication (e.g. sodium bicarbonate, theophyllin, sevoflurane) -Need for non-invasive/invasive mechanical ventilation (+ duration) -Frequency of side effects (Tachycardia, Arrhythmia, Hypotension, Hypokalaemia, Hyperglycaemia, Lactic acidosis) -Distribution of ADBR2 receptor polymorphisms ;Main Objective: 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.;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: 1 hour after administration of loading dose of IV salbutamol

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Secondary

Measure	Time frame
Secondary end point(s): • The (reduction of) asthma score (Qureshi) 6 hours after administration of loading dose in the intervention group compared to the placebo group. • 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 (categorical) (Tachycardia, Arrhythmia, Hypotension, Hypokalaemia, Hyperglycaemia, Lactic acidosis) • Length of Stay on PICU in days • Use of co-medication + dosage + timing (e.g. sodium bicarbonate, theophylline, sevoflurane) • Use of prednisone + time/method of first administration • Use of/duration of non-invasive/invasive mechanical ventilation in days • Distribution of ADRB2-receptor polymorphisms (SNPs for Arginine and Glycine on chromosomes 16 and 27) compared to normal population (non-SAA) ;Timepoint(s) of evaluation of this end point: Asthma score will be measured at baseline and the following timepoints after administration of IV salbutamol loading dose: 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours and >24 hours. The remaining secondary end points have no specific time points.	—

Measure

Time frame

Secondary end point(s): • The (reduction of) asthma score (Qureshi) 6 hours after administration of loading dose in the intervention group compared to the placebo group. • 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 (categorical) (Tachycardia, Arrhythmia, Hypotension, Hypokalaemia, Hyperglycaemia, Lactic acidosis) • Length of Stay on PICU in days • Use of co-medication + dosage + timing (e.g. sodium bicarbonate, theophylline, sevoflurane) • Use of prednisone + time/method of first administration • Use of/duration of non-invasive/invasive mechanical ventilation in days • Distribution of ADRB2-receptor polymorphisms (SNPs for Arginine and Glycine on chromosomes 16 and 27) compared to normal population (non-SAA) ;Timepoint(s) of evaluation of this end point: Asthma score will be measured at baseline and the following timepoints after administration of IV salbutamol loading dose: 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours and >24 hours. The remaining secondary end points have no specific time points.

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Countries

Netherlands

Contacts

Public Contactdrs. J.M.C. van Wijngaarden

Erasmus MC - Sophia Children's Hospital

j.vanwijngaarden@erasmusmc.nl00310107038938

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026