Background: Asthma is a common problem in children and, if inadequately controlled, may seriously diminish\ntheir quality of life. Inhaled short-acting beta2 agonists such as salbutamol are usually prescribed as ââ?¬Ë?relieverââ?¬â?¢\nmedication to help control day-to-day symptoms such as wheeze. As with many medications currently\nprescribed for younger children (defined as those aged 2 years 6 months to 6 years 11 months), there has\nbeen no pre-licensing age-specific pharmacological testing; consequently, the doses currently prescribed\n(200ââ?¬â??1000 Ã?¼g) may be ineffective or likely to induce unnecessary side effects. We plan to use the interrupter\ntechnique to measure airway resistance in this age group, allowing us for the first time to correlate inhaled\nsalbutamol dose with changes in clinical response. We will measure urinary salbutamol levels 30 min after\ndosing as an estimate of salbutamol doses in the lungs, and also look for genetic polymorphisms linked to\npoor responses to inhaled salbutamol.\nMethods: This is a phase IV, randomised, controlled, observer-blinded, single-centre trial with four parallel\ngroups (based on a sparse sampling approach) and a primary endpoint of the immediate bronchodilator\nresponse to salbutamol so that we can determine the most appropriate dose for an individual younger child.\nSimple randomisation will be used with a 1:1:1:1 allocation.\nDiscussion: The proposed research will exploit simple, non-invasive and inexpensive tests that can mostly be\nperformed in an outpatient setting in order to help develop the evidence for the correct dose of salbutamol\nin younger children with recurrent wheeze who have been prescribed salbutamol by their doctor.
Loading....