Spiromax inhalations by young children
Research type
Research Study
Full title
Can young children use two different version of a Spiromax dry powder inhaler (DPI).
IRAS ID
149195
Contact name
Henry Chrystyn
Contact email
Sponsor organisation
University of Huddersfield
Research summary
At present young children with asthma receive their medication using a metered dose inhaler attached to a spacer. Although many can use this method others cannot and due to its size the spacer is not easily portable. Dry powder inhalers are easy to use and there are suggestions that young children with asthma can make the required fast suck when using these devices. We have shown that 4 year olds with asthma can use these inhalers. The aim of this study is to instruct parents /carers how to use the inhaler so that they can train their 2 or 3 years old child, who has asthma, to make an inhalation manoeuvre through the inhaler. This inhalation parameters will be compared to in-vitro data to identify the type of dose each user would have inhaled if the inhaler had contained a dose.
Parents / carers will be instructed how to use each inhaler and they, in turn, will train their child how to use it. Each child will make the trained inhalation manoeuvre through an empty inhaler linked to an inhalation profile recorder. Two different inhalers will be made and each child will make two separate inhalations with each inhaler. From the profiles we will identify if these profiles meet those that have been identified for correct use of the inhaler. If this is so then further studies will be carried out so that young children could be allowed to use these inhalers.
Each inhaler will be empty and so no user will receive any medicine during each inhalation.
All the study will be completed in one visit and should last about 30 minutes.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
14/YH/0122
Date of REC Opinion
5 Jun 2014
REC opinion
Further Information Favourable Opinion