How a throw-away paper cup can save the life of a child with asthma

A disposable cup - favoured by many of the high street's well known coffee shops - is the inspiration behind a new and scientifically reviewed device for the safe and prompt treatment of school age children suffering acute asthma, which often presents as an emergency situation.

The new, single use DispozABLE™ Spacer² (a valve-less holding chamber to help with the optimal delivery of salbutamol sulphate, a drug most commonly known as Ventolin®) has been developed by the technical team at UK-based medical device manufacturers, Clement Clarke International and has received wide recognition via publications in leading journals¹ and at major conferences.

A scientific poster presented at the recent International Society for Aerosols in Medicine (ISAM) conference (Munich, 30 May - 3 June 2015) detailed the results of an independent study into the use of spacers with a pMDI (pressurized metered dose inhaler) as opposed to a pMDI alone, showed that the DispozABLE™ Spacer is suitable for the effective delivery of salbutamol sulphate. The study also reinforced that at low flows, this type of valve-less spacer may perform better than other VHCs (valved holding chambers) which has real clinical implications for infants and children.

Historically, poor pMDI technique led to the development of chamber and spacer devices, the use of which is recommended in international guidelines. Essentially, these devices were designed to permit the patient to disassociate the actions of pressing the canister and inhaling, which overcomes many of the issues with co-ordination and means that the patient receives the full dose. Furthermore, the chamber and spacer devices minimise the unwanted deposition of medication in the throat, thus reducing potential side effects.

It is becoming increasingly recognised that VHC's require a certain "breathing effort" in order to operate the built-in valve and this might be difficult for a young child or a child who is distressed. Plastic VHCs should be carefully preconditioned before first use to avoid the static charge on the chamber reducing the delivered dose. These technical factors - along with cost, lack of training or official asthma policy - may have deterred some schools from keeping the emergency equipment on-site and therefore potentially placing children at risk.

However, with around a million children in the UK being treated for asthma, in March 2015 the Government launched new guidelines³ to keep these young people safe in schools, legislating that spare, emergency inhalers and spacers may be kept on site - providing care for the child and reassurance for parents.

Mark Sanders, Managing Director of Clement Clarke International and co-author of the recent study comments; "The launch of this new, 'single use / single patient' spacer is extremely timely with the recent shift in understanding about the importance of emergency asthma management in the school setting.

"DispozABLE™ can be used straight from the pack and has been designed to meet a specific market need for a low cost, fast response spacer for delivering medication efficiently.

This is not the first time that the concept of a paper cup spacer has been explored. Around 10 years ago, an Australian research project⁴ concluded that "management guidelines can be modified to include the use of a disposable paper cup in settings where there is concern about cross-infection and where a casualty does not have their own pMDI or access to a clean commercially produced spacer device for the first aid management of an asthma attack."

Mr Sanders adds; "There was much excitement about this published research a decade ago but the concept didn't become commercially viable at the time. However the clever design of a lid that is both a mouthpiece at the top and an inhaler port at the bottom has allowed us to create an extremely user-friendly and cost effective device, with an intuitive design to allow non-professionals to assemble it quickly and safely."

"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 are treated swiftly."

"Life-saving asthma medications have been available since the 1970s but unless they are delivered effectively to a patient in need, we will continue to see instances of people dying from an asthma emergency - often when they are alone but also in public places such as schools. This is simply not acceptable and we believe schools now have a responsibility to ensure they are fully equipped and ready to deal with an emergency."

An earlier study⁵, also published in the Journal of Aerosol Medicine and Pulmonary Drug Delivery (Volume 28, Number 3 June 2015) modelled a situation when a child might be treated "sub-optimally" with their salbutamol sulphate (Ventolin) medication⁶ (which is often the case in a panicked, emergency situation). The independent study showed that the pMDI plus the DispozABLE™ spacer performed much better than the pMDI alone, delivering almost the full dose.

Angela Jones, Practice Nurse and Asthma Nurse Specialist comments; "From my experience there are huge discrepancies in the levels of asthma care within schools. Some have excellent policies in place, are well organised with confident, trained staff - whether that's a designated teacher or member of the office team.

"However, when I worked as school nurse, all too often I would come across teachers and support staff who simply did not have the confidence or basic knowledge to manage an asthma emergency. They were worried about hygiene and safety issues as well as assembling the equipment incorrectly and ultimately doing more harm than good.

"The effects of such a 'hands off' response can be catastrophic although I do believe the recent introduction of new legislation will start to break down these barriers and reinforce the importance of ensuring children with asthma are safe when at school. As such, I fully support the introduction of any device - the simpler the better - that encourages school staff to be more 'hands on'.

The British Thoracic Society, which also advocates the use of spacers and VHCs for all children taking asthma medications from pressurised inhalers, commented; "Breakthroughs don't always have to involve seismic technological developments and costly multi-centred research....Now that schools are faced with obtaining inhalers and spacers, this seems both timely and innovative!"