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

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

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.

Condition or disease Intervention/treatment Phase
Childhood Asthma With Status Asthmaticus Drug: Salbutamol Drug: Sodium Chloride 0.9% Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Loading Dose of IV Salbutamol in Children Admitted to a PICU for Severe Acute Asthma or Severe Acute Wheeze
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019


Arm Intervention/treatment
Experimental: Salbutamol loading dose
Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg.
Drug: Salbutamol
Intravenous Salbutamol loading dose

Placebo Comparator: Sodium Chloride 0.9%
10 ml of Sodium Chloride 0.9% in 10 minutes.
Drug: Sodium Chloride 0.9%
10 ml of Sodium Chloride 0.9% in 10 minutes intravenous




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cumulative dose of IV salbutamol [ Time Frame: Through study completion, an average 48 hours ]
  2. Maximum infusion rate of IV salbutamol in mcg/kg/min [ Time Frame: Through study completion, an average 48 hours ]
  3. Total duration of IV salbutamol treatment in hours [ Time Frame: Through study completion, an average 48 hours ]
  4. Occurrence/frequency of side effects [ Time Frame: Through study completion, an average 48 hours ]
  5. Length of Stay on PICU in days [ Time Frame: Through study completion, an average 72 hours ]
  6. Use of co-medication [ Time Frame: Through study completion, an average 72 hours ]
  7. Use of/duration of non-invasive mechanical ventilation in days [ Time Frame: Through study completion, an average 72 hours ]
  8. 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.

  9. Use of/duration of non-invasive/invasive mechanical ventilation in days [ Time Frame: Through study completion, an average 72 hours ]


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493503


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

Locations
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Netherlands
Erasmus MC Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3000WB
Contact: Shelley Boeschoten, MD    0031630035001    s.boeschoten@erasmusmc.nl   
Sponsors and Collaborators
Erasmus Medical Center

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Responsible Party: Matthijs de Hoog, Prof. Dr., Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03493503     History of Changes
Other Study ID Numbers: NL55029.078.16
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

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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
Additional relevant MeSH terms:
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Asthma
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action