The mainstay of asthma treatment worldwide are ß2-agonists and steroids. Current management of childhood acute asthma is based on British Thoracic Society guidelines, which recommend IVS as second line treatment. Whilst IVS can be highly effective in reversing bronchospasm, the overall evidence for this recommendation is week and predominantly comes from a single study. IVS has also been associated with side effects such as arrhythmias, lactic acidosis and diastolic hypotension.
Conditions
Interventions
Trade Name: Ventolin injection
Product Name: Salbutamol sulphate
Pharmaceutical Form: Concentrate and solvent for suspension for injection
INN or Proposed INN: Salbutamol sulphate
CAS Number: 18559-94
Sponsors
Great Ormond Street Hospital For Children NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 1-15 years (inclusive) with acute severe asthma as defined by the BTS guidelines are eligible 2. About to receive / receiving IVS 3. ED cohort: Patients being admitted for acute asthma treatment in the Royal London Hospital or St Mary’s Hospital EDs while the research nurse is in attendance 4. CATS cohort: Patients being retrieved by the CATS team to Great Ormond Street Hospital or St Mary’s Hospital PICU over the study period. Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Patients being admitted to hospital for a primary reason other than asthma management will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We wish to determine the best way to use a crucial drug called salbutamol in children with life-threatening asthma. We wish to analyse how the dose of salbutamol relates to its blood concentration level; and how the blood concentration level relates to effectiveness and toxicity. This study will allow us develop a population pharmacokinetic-pharmacodynamics (PKPD) model of salbutamol in children. This will enable us to determine the optimal dose of salbutamol; to maximise its effectiveness but minimise harmful side effects. ;Secondary Objective: We will also explore if there are patient-specific reasons why some children respond differently to treatment. We will analyse if age, sex, weight, height, creatinine clearance, ethnicity or genotype can predict a variation in treatment response. This could influence patient-specific treatment models in the future. We will also analyse the effect of concurrent medication used in the course of asthma treatment on our results. ;Primary end point(s): The primary outcome measure is a paediatric population PKPD model for salbutamol in acute severe asthma.;Timepoint(s) of evaluation of this end point: PKPD modelling will be performed at the end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Once PKPD modelling has been performed, we will analyse if age, sex, weight, height, creatinine clearance, ethnicity or genotype can predict a variation in treatment response. This will be performed at the final analysis.;Timepoint(s) of evaluation of this end point: Analysis at the end of the trial | — |
Countries
United Kingdom
Contacts
Public ContactAvani Shukla
GOSH/ICH & UCL Institute of Child Health
Outcome results
None listed