Have you or your loved ones been diagnosed with childhood asthma with status asthmaticus?

You may be eligible to participate in a childhood asthma with status asthmaticus clinical trial.

Have you or your loved ones been diagnosed with childhood asthma with status asthmaticus? You may be eligible to participate in a childhood asthma with status asthmaticus clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Childhood Asthma With Status Asthmaticus Clinical Trial in Rotterdam Zuid-Holland

NCT03493503 | Phase 4 | Interventional

Have you or your loved ones been diagnosed with childhood asthma with status asthmaticus?

You may be eligible to participate in a childhood asthma with status asthmaticus clinical trial.

Have you or your loved ones been diagnosed with childhood asthma with status asthmaticus? You may be eligible to participate in a childhood asthma with status asthmaticus clinical trial.

Completed

Male & Female

2 - 18

Years old

This study has recruited 58 Participants

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.

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Details for the study

Brief Title

Status Asthmaticus on the PICU; Intravenous Salbutamol

Official Title

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

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.

Treatments and/or Procedures

Sodium chloride 0 9

10 ml of Sodium Chloride 0.9% in 10 minutes intravenous

Salbutamol

Intravenous Salbutamol loading dose

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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

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

Study 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