Status Asthmaticus on the PICU; Intravenous Salbutamol (STATIC IV)

• ClinicalTrials.gov Identifier: NCT03493503
• Recruitment Status: Recruiting
• First Posted: April 10, 2018
• Last Update Posted: April 10, 2018
• Sponsor: Erasmus Medical Center
• Information provided by (Responsible Party): Matthijs de Hoog, Erasmus Medical Center

Tracking Information

• First Submitted Date: March 12, 2018
• First Posted Date: April 10, 2018
• Last Update Posted Date: April 10, 2018
• Actual Study Start Date: April 5, 2017
• Estimated Primary Completion Date: February 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 3, 2018)

Reduction Asthma score [ Time Frame: First 24 hours after admission on the PICU ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 3, 2018)

• Cumulative dose of IV salbutamol [ Time Frame: Through study completion, an average 48 hours ]
• Maximum infusion rate of IV salbutamol in mcg/kg/min [ Time Frame: Through study completion, an average 48 hours ]
• Total duration of IV salbutamol treatment in hours [ Time Frame: Through study completion, an average 48 hours ]
• Occurrence/frequency of side effects [ Time Frame: Through study completion, an average 48 hours ]
• Length of Stay on PICU in days [ Time Frame: Through study completion, an average 72 hours ]
• Use of co-medication [ Time Frame: Through study completion, an average 72 hours ]
• Use of/duration of non-invasive mechanical ventilation in days [ Time Frame: Through study completion, an average 72 hours ]
• DNA polymorphism of the ADRB2-receptor gene [ Time Frame: Through study completion, an average 1 year ]
  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 [ Time Frame: Through study completion, an average 72 hours ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Childhood Asthma With Status Asthmaticus

Intervention

• Drug: Salbutamol
  Intravenous Salbutamol loading dose
• Drug: Sodium Chloride 0.9%
  10 ml of Sodium Chloride 0.9% in 10 minutes intravenous

Study Arms

• Experimental: Salbutamol loading dose
  Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg.
  Intervention: Drug: Salbutamol
• Placebo Comparator: Sodium Chloride 0.9%
  10 ml of Sodium Chloride 0.9% in 10 minutes.
  Intervention: Drug: Sodium Chloride 0.9%

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 3, 2018): 56
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 1, 2019
• Estimated Primary Completion Date: February 1, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Shelley Boeschoten, MD; 0031630035001; s.boeschoten@erasmusmc.nl

• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT03493503
• Other Study ID Numbers: NL55029.078.16
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Responsible Party: Matthijs de Hoog, Erasmus Medical Center
• Study Sponsor: Erasmus Medical Center
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Erasmus Medical Center
• Verification Date: April 2018