PKPD of intravenous salbutamol in paediatric acute severe asthma
Research type
Research Study
Full title
Optimising effectiveness and minimising toxicity of intravenous salbutamol in children with acute asthma
IRAS ID
162322
Contact name
Praseeda Thaikalloor
Contact email
Sponsor organisation
Great Ormond Street Hospital for Children NHS Foundation Trust
Eudract number
2014-002996-27
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Every 18 minutes, a child is admitted to hospital with asthma. Intravenous salbutamol (IVS) is the main drug treatment for life-threatening asthma and has saved countless lives. However, current dosage recommendations lead to frequent high dosages with side effects in many children. The purpose of this study is to develop a population pharmacokinetic-pharmacodynamics (PKPD) model to explore the relationship between salbutamol dose, blood concentration, effectiveness and side effects in children with acute severe asthma.
This study is a prospective observational study being conducted over an 18 month period. Children with acute severe asthma receiving IVS as per their local hospital guidelines will be included. The study will involve measuring serial salbutamol concentration levels, measuring signs of effectiveness and measuring signs of toxicity in these patients. We will also observe for patient-specific factors that may influence these results e.g. age, sex, weight, height, genotype, ethnicity, creatinine clearance and concomitant drug treatments.
Children will be recruited in three centres in London as part of two arms of the study:
1. The EDs of two tertiary hospitals. A research nurse with no involvement in clinical management will be in attendance here to carry out the study.
2. Patients being retrieved by the Children’s Acute Transport Service two PICUs for acute severe asthma. The clinical teams will obtain clinical measurements as per standard practice, and obtain research blood samples for the study.The results of our study will help develop new rational, evidence-based dosage guidelines for IVS that can be evaluated in future randomised clinical trials.
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/2103
Date of REC Opinion
2 Feb 2015
REC opinion
Further Information Favourable Opinion