Top Wasp
Research type
Research Study
Full title
The use of pressurised metered dose inhalers with and without spacers in paediatric patients with asthma– an in vitro/in vivo correlation study of breathing pattern and lung deposition
IRAS ID
256221
Contact name
Matthew Peak
Contact email
Sponsor organisation
Alder hey Children's hospital NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 29 days
Research summary
Pressurised metered dose inhalers (pMDIs) are widely prescribed; however, their efficacy is critically dependent upon the patient’s aptitude to learn and demonstrate correct inhaler technique (Virchow et al., 2008). Common barriers to optimal technique include: poor coordination of inhalation with inhaler actuation; ceasing to inhale shortly after activating the pMDI; inspiration through the nose (Pedersen, 1986). Furthermore, many patients fail to inhale slowly and deeply through their pMDI in order to achieve the desired inhalation flow rate (< 90 L/min) for a sufficient lung deposition (Al-Showair et al., 2007). Literature indicates poor pMDI technique to be a problem of wide magnitude, with 14-89% of patients of all age groups found to exhibit at least one error or complete incorrect usage of the device (Larsen et al., 1994). The impact of poor inhaler technique is amplified in younger populations. Spacer devices have been introduced to compensate for poor inhaler technique (despite repeated training) when used in combination with pMDIs (Walia et al., 2006). Alternatively, breath actuated inhalers (Newman et al., 1991) or dry powder inhalers (DPIs) may be prescribed to remedy poor technique (Virchow et al., 2008). However, the use of DPIs is not recommended for paediatric patients (Lavorini et al., 2008, Lexmond et al., 2014).
To date, studies have looked at comparing inhaler devices in vitro using inhaler testing equipment (Brocklebank D, 2001, Alotaibi et al., 2011). Additionally, more recent studies have focused on investigating the use of pMDIs with and without spacers in vitro (Anderson et al., 2018, Dissanayake and Suggett, 2018). However, there are no robust data about the inhalation manoeuvres of paediatric patients, and certainly no studies that bridge in vivo parameters and in vitro data for children with asthma. Therefore, we propose to collect breathing inhalation profiles from children with asthma, and using a Breathing Simulator and an in vitro inhaler testing equipment (Next Generation Impactor) to determine drug particle deposition in the lungs. We will investigate the relationships between age, gender, breathing pattern, asthma severity, use and type of spacer device on drug deposition in the lung of children with asthma.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0796
Date of REC Opinion
27 Nov 2018
REC opinion
Favourable Opinion