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

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.

Monitoring respiration in wheezy preschool children by pulse oximetry plethysmogram analysis.

The aim of this study was to investigate whether respiratory information can be derived from pulse oximetry plethysmogram (pleth) recordings in acutely wheezy preschool children. A digital pulse oximeter was connected via 'Bluetooth' to a notebook computer in order to acquire pleth data. Low pass filtering and frequency analysis were used to derive respiratory rate from the pleth trace; the ratio of heart rate to respiratory rate (HR/RR) was also calculated. Recordings were obtained during acute wheezy episodes in 18 children of median age 31 months and follow-up recordings from 16 of the children were obtained when they were wheeze-free. For the acutely wheezy children, frequency analysis of the pleth waveform was within 10 breaths/min of clinical assessment in 25 of 29 recordings in 15 children. For the follow-up measurements, frequency analysis of the pleth waveform showed similarly good agreement in recordings on 15 of the 16 children. Respiratory rate was higher (p < 0.001), and HR/RR ratio was lower (p = 0.03) during acute wheeze than at follow-up. This study suggests that respiratory rate can be derived from pleth traces in wheezy preschool children.