How can we optimise inhaled beta2 agonist dose as a reliever medicine for wheezy pre school children.pdf (561.21 kB)
How can we optimise inhaled beta2 agonist dose as ‘reliever’ medicine for wheezy pre-school children? Study protocol for a randomised controlled trial
Version 2 2023-06-12, 08:33
Version 1 2023-06-09, 03:21
journal contribution
posted on 2023-06-12, 08:33 authored by Somnath MukhopadhyaySomnath Mukhopadhyay, Paul Seddon, Gemma Earl, Emma Wileman, Liz Symes, Cathy Olden, Corinne Alberti, Stephen BremnerStephen Bremner, Alison Lansley, Colin N A Palmer, Nicole BeydonBackground: 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 µg) 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.
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- Published
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- Published version
Journal
TrialsISSN
1745-6215Publisher
BioMed CentralExternal DOI
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541Volume
17Department affiliated with
- Primary Care and Public Health Publications
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- Yes
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- Yes
Legacy Posted Date
2016-10-07First Open Access (FOA) Date
2016-10-07First Compliant Deposit (FCD) Date
2016-10-07Usage metrics
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