Status Asthmaticus on the PICU; Intravenous Salbutamol

NCT ID: NCT03493503

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-05

Study Completion Date

2019-05-21

Brief Summary

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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.

Detailed Description

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Conditions

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Childhood Asthma With Status Asthmaticus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Salbutamol loading dose

Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg.

Group Type EXPERIMENTAL

Salbutamol

Intervention Type DRUG

Intravenous Salbutamol loading dose

Sodium Chloride 0.9%

10 ml of Sodium Chloride 0.9% in 10 minutes.

Group Type PLACEBO_COMPARATOR

Sodium Chloride 0.9%

Intervention Type DRUG

10 ml of Sodium Chloride 0.9% in 10 minutes intravenous

Interventions

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Salbutamol

Intravenous Salbutamol loading dose

Intervention Type DRUG

Sodium Chloride 0.9%

10 ml of Sodium Chloride 0.9% in 10 minutes intravenous

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Matthijs de Hoog

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erasmus MC

Rotterdam, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL55029.078.16

Identifier Type: -

Identifier Source: org_study_id

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