How can we optimise inhaled beta2 agonist dose as 'reliever' medicine for wheezy pre-school children?: Study protocol for a randomised controlled trial

Somnath Mukhopadhyay; Paul Seddon; Gemma Earl; Emma Wileman; Liz Symes; Cathy Olden; Corinne Alberti; Stephen Bremner; Alison Lansley; Colin N. A. Palmer; Nicole Beydon

doi:10.1186/s13063-016-1437-7

How can we optimise inhaled beta2 agonist dose as 'reliever' medicine for wheezy pre-school children? Study protocol for a randomised controlled trial

Somnath Mukhopadhyay (Lead / Corresponding author), Paul Seddon, Gemma Earl, Emma Wileman, Liz Symes, Cathy Olden, Corinne Alberti, Stephen Bremner, Alison Lansley, Colin N. A. Palmer, Nicole Beydon

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Abstract

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 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.

Original language	English
Article number	541
Pages (from-to)	1-9
Number of pages	9
Journal	Trials
Volume	17
DOIs	https://doi.org/10.1186/s13063-016-1437-7
Publication status	Published - 11 Nov 2016

Keywords

Asthma
Wheeze
Children
Paediatric
Salbutamol
Dose finding

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© 2016 Mukhopadhyay et al. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Final published version, 561 KBLicence: CC BY

Cite this

Mukhopadhyay, S., Seddon, P., Earl, G., Wileman, E., Symes, L., Olden, C., Alberti, C., Bremner, S., Lansley, A., Palmer, C. N. A., & Beydon, N. (2016). How can we optimise inhaled beta2 agonist dose as 'reliever' medicine for wheezy pre-school children? Study protocol for a randomised controlled trial. Trials, 17, 1-9. Article 541. https://doi.org/10.1186/s13063-016-1437-7

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abstract = "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 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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author = "Somnath Mukhopadhyay and Paul Seddon and Gemma Earl and Emma Wileman and Liz Symes and Cathy Olden and Corinne Alberti and Stephen Bremner and Alison Lansley and Palmer, {Colin N. A.} and Nicole Beydon",

note = "The trial is funded by the UK National Institute for Health Research (NIHR) Research for Patient Benefit scheme (reference PB-PG-0712-28097).",

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day = "11",

doi = "10.1186/s13063-016-1437-7",

language = "English",

volume = "17",

pages = "1--9",

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T1 - How can we optimise inhaled beta2 agonist dose as 'reliever' medicine for wheezy pre-school children?

T2 - Study protocol for a randomised controlled trial

AU - Mukhopadhyay, Somnath

AU - Seddon, Paul

AU - Earl, Gemma

AU - Wileman, Emma

AU - Symes, Liz

AU - Olden, Cathy

AU - Alberti, Corinne

AU - Bremner, Stephen

AU - Lansley, Alison

AU - Palmer, Colin N. A.

AU - Beydon, Nicole

N1 - The trial is funded by the UK National Institute for Health Research (NIHR) Research for Patient Benefit scheme (reference PB-PG-0712-28097).

PY - 2016/11/11

Y1 - 2016/11/11

N2 - 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 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.

AB - 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 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.

KW - Asthma

KW - Wheeze

KW - Children

KW - Paediatric

KW - Salbutamol

KW - Dose finding

U2 - 10.1186/s13063-016-1437-7

DO - 10.1186/s13063-016-1437-7

M3 - Article

C2 - 27836009

SN - 1745-6215

VL - 17

SP - 1

EP - 9

JO - Trials

JF - Trials

M1 - 541

ER -

How can we optimise inhaled beta2 agonist dose as 'reliever' medicine for wheezy pre-school children? Study protocol for a randomised controlled trial

Abstract

Keywords

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