Status Asthmaticus on the PICU; Intravenous Salbutamol

NCT03493503 | Completed Phase 4 DMC

• 1 other identifier: NL55029.078.16
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Asthma With Status Asthmaticus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Cumulative dose of IV salbutamol

  Through study completion, an average 48 hours

• Maximum infusion rate of IV salbutamol in mcg/kg/min

  Through study completion, an average 48 hours

• Total duration of IV salbutamol treatment in hours

  Through study completion, an average 48 hours

• Occurrence/frequency of side effects

  Through study completion, an average 48 hours

• Length of Stay on PICU in days

  Through study completion, an average 72 hours

Study Arms (2)

Salbutamol loading dose

EXPERIMENTAL

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

Drug: Salbutamol

Sodium Chloride 0.9%

PLACEBO COMPARATOR

10 ml of Sodium Chloride 0.9% in 10 minutes.

Drug: Sodium Chloride 0.9%

Interventions

Salbutamol DRUG

Intravenous Salbutamol loading dose

Salbutamol loading dose

Sodium Chloride 0.9% DRUG

10 ml of Sodium Chloride 0.9% in 10 minutes intravenous

Sodium Chloride 0.9%

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Admitted to PICU for Severe Acute Asthma or Severe acute (viral) wheeze
• Requiring administration of IV salbutamol

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3000WB, Netherlands

Location

MeSH Terms

Interventions

Albuterol; Sodium Chloride

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: April 10, 2018
• Study Start: April 5, 2017
• Primary Completion: May 21, 2019
• Study Completion: May 21, 2019
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

NL (1)