AsthmaAn ingenious new device from medical manufacturer Clement Clarke International (CCI) aims to change the way young children are taught to inhale their medication, the manufacturer has said.

Using a poster presentation at the European Respiratory Society International Congress (3 September 2016), the company will highlight the advantages of a new type of facemask, specially designed for young children who are learning the essential breathing techniques that allow them to receive the correct amount of medication when using a spacer.

Over the past 30 years, children have been taught that a “whistle-sound” indicates that breathing technique is poor (too fast) and therefore medication is not being delivered effectively. However, the team from Clement Clarke has developed a new mask that guides correct breathing technique and facilitates better fitting (as part of the Able Spacer Pack) for “smaller children with smaller faces”

The updated Able Spacer will see a whistle embedded into the mask that sounds when the correct technique has been mastered and the fit is correct. From September it will be the first ever asthma face mask of its type available on prescription – at no extra cost to the NHS. 

It will also be the first prescription respiratory device with a free gamification App, developed by Dr Tariq Aslam, founder of University of Manchester spin-out, Clin-e-Cal Ltd, in response to his son Rafi’s problems with accepting a spacer. The app helps children to accept having a mask on their face by using a fun, animated game (as a free download on both I-phone and android devices).

The concept of the “Rafi-Tone” App is simple – the whistle sound emitted by the mask when the young user is breathing with the spacer correctly is capable of driving the Rafi robot through a series of challenges as it fights off the attacking “baddies.” 

The gadget behind the innovation is a precision plastic reed that is embedded in the small facemask, which emits a tone at a specific frequency as the user inhales medication. It originated in Clement Clarke’s Flo-Tone device. 

Mark Sanders of Clement Clarke International said: “Originally we designed the Flo-Tone as a training tool to help people to use their inhalers properly, because poor inhaler technique is a widespread problem that limits the benefit people should get from their medication. However, we recognised early-on that existing spacer whistles were negative reinforcement alerts and they created a great deal of confusion, what was really needed was the opposite. So we constructed mouthpieces and now masks that could work with a precision reed, engineered so that the whistle went off at a certain flow rate. The whistle became the guiding signal to activate the inhaler, with the duration of the sound giving a clue to how long and deep the inhalation was. For the mask, hearing the whistle is also confirmation that the mask is properly fitted without leaks, which is not always easy to establish when the young patient is reluctant to accept a face mask.

“The safety of children with asthma is absolutely paramount and we are passionate about bringing novel designs to market to ensure that all young people can receive their medication in the best, quickest and easiest way possible. Life-saving asthma medications have been available since the 1970s but unless they are delivered effectively to patients in need, we will continue to see instances of young people becoming breathless, frightened and requiring emergency services.” 

ERS presentation

The new research to be presented at the ERS involved 24 healthy volunteers with an average age of 5 ½ years and will pave the way for further clinical studies. Of this group, 16 children were able to generate the audible whistle, with just four (aged between 18 months and 3 years) unable to make an audible sound. All the children over the age of 3 used the mask successfully although the toddlers required additional coaching. 

Respiratory paediatrician Dr Clare Murray from the University of Manchester and who has been involved with the development of Rafi-Tone and the new Able Spacer pack, said: “From the outset, I thought it was a great idea because we don’t really have any way of using incentive devices with spacers. Some children just take to it but there’s a number, particularly the little ones, who either get scared or just are bored by it and therefore simply won’t do it. So I thought having something that would entertain them whilst potentially improving their inhaler technique at the same time would be an interesting idea!

“With researchers and respiratory experts working collaboratively with the team at Clement Clarke, it has been possible to programme an app that gives us a very easy way of making spacer use more fun.”