Related Experiment Video
Updated: Mar 12, 2026
Author Spotlight: Efficacy of Auricular Pressure Bean Therapy in Reducing Wheezing Symptoms
Published on: May 10, 2024
How can we optimise inhaled beta2 agonist dose as 'reliever' medicine for wheezy pre-school children? Study protocol
Somnath Mukhopadhyay1, Paul Seddon2, Gemma Earl3
1Academic Department of Paediatrics, Royal Alexandra Children's Hospital, Eastern Road, Brighton, East Sussex, BN2 3BE, UK. s.mukhopadhyay@bsms.ac.uk.
Insights
This study aims to find the optimal salbutamol dose for young children with asthma. By measuring airway resistance and drug levels, researchers will determine effective and safe dosages for wheeze control.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
- Respiratory Medicine
Background:
- Asthma is common in children, impacting quality of life.
- Current salbutamol (albuterol) dosing for young children lacks age-specific testing, risking ineffective treatment or side effects.
- Younger children (2.5–6.11 years) often receive unverified salbutamol doses.
Purpose of the Study:
- To determine the most appropriate inhaled salbutamol dose for individual younger children.
- To correlate salbutamol dose with clinical response using airway resistance measurements.
- To establish evidence-based dosing for salbutamol in pediatric wheeze management.
Main Methods:
- Phase IV, randomized, controlled, observer-blinded, single-center trial.
- Four parallel groups utilizing a sparse sampling approach.
- Interrupter technique to measure airway resistance; urinary salbutamol levels to estimate lung dose.
Main Results:
- Primary endpoint: immediate bronchodilator response to salbutamol.
- Data collection to inform optimal dosing for younger children.
- Investigation of genetic polymorphisms affecting salbutamol response.
Conclusions:
- The research will provide evidence for correct salbutamol dosing in younger children with recurrent wheeze.
- Utilizes simple, non-invasive, and inexpensive outpatient tests.
- Aims to improve asthma symptom control and reduce adverse effects in pediatric patients.
Background:
Asthma is a common problem in children and, if inadequately controlled, may seriously diminish their quality of life. Inhaled short-acting beta2 agonists such as salbutamol are usually prescribed as 'reliever' medication to help control day-to-day symptoms such as wheeze. As with many medications currently prescribed for younger children (defined as those aged 2 years 6 months to 6 years 11 months), there has been no pre-licensing age-specific pharmacological testing; consequently, the doses currently prescribed (200-1000 microg) may be ineffective or likely to induce unnecessary side effects. We plan to use the interrupter technique to measure airway resistance in this age group, allowing us for the first time to correlate inhaled salbutamol dose with changes in clinical response. We will measure urinary salbutamol levels 30 min after dosing as an estimate of salbutamol doses in the lungs, and also look for genetic polymorphisms linked to poor responses to inhaled salbutamol.
Methods:
This is a phase IV, randomised, controlled, observer-blinded, single-centre trial with four parallel groups (based on a sparse sampling approach) and a primary endpoint of the immediate bronchodilator response to salbutamol so that we can determine the most appropriate dose for an individual younger child. Simple randomisation will be used with a 1:1:1:1 allocation.
Discussion:
The proposed research will exploit simple, non-invasive and inexpensive tests that can mostly be performed in an outpatient setting in order to help develop the evidence for the correct dose of salbutamol in younger children with recurrent wheeze who have been prescribed salbutamol by their doctor.
Trial Registration:
EudraCT2014-001978-33, ISRCTN15513131. Registered on 8 April 2015.
Related Concept Videos
01:30Asthma-IV: Diagnostic and Management
Clinical Assessment for Asthma:
This is the first step in diagnosing and managing asthma. It includes:
01:23Inhaled Medications
01:25Antiasthma Drugs: β2-Adrenoceptor Agonists
One class of bronchodilators includes β2-adrenoceptor agonists. These agents target the β2-adrenoceptors located on bronchial smooth muscle cells. By stimulating these receptors, β2-agonists induce...
01:26Asthma-II: Pathophysiology and Classification
Additionally, environmental and genetic factors play crucial roles in determining an individual's susceptibility to asthma and the severity of their condition.
Critical processes in asthma pathophysiology include:
01:17Drugs Used in Lower Respiratory Disorders: Overview
Bronchodilators, the first step of respiration enhancement, come in various forms, each with its own mechanism...
01:20Asthma: Pathogenesis and Management
Asthma is classified as allergic and non-allergic. Allergens such as dust mites, pollen, and pet dander trigger allergic asthma, while factors like cold air, intense emotions, or exercise can induce non-allergic asthma.