The Global Inhaler Effectiveness Score (GIES): A Novel Tool for Assessing and Ranking in vitro Properties and Patients Usability of Dry Powder Inhalers. Rationale and Methodology
Francesca Buttini1, Federico Lavorini2, Ruggero Bettini1,
Søren E. Pedersen4; Richard P.N. Dekhuijzen5, Mark L. Levy6 and Omar S. Usmani7
1Food and Drug Department, University of Parma, IT
2Careggi University Hospital, Florence, IT
4Paediatric Research Unit, University of Southern Denmark, Kolding Hospital, DK
5Department of Pulmonary Diseases, Radboud University Nijmegen Medical Centre, NL
6Kenton Bridge Medical Centre, London, UK
7Imperial College London and Royal Brompton Hospital, London, UK
Inhaled drug delivery is the cornerstone treatment for asthma and chronic obstructive pulmonary disease (COPD). However, successful of inhaled therapies is related to inhaler intrinsic efficiency and proper inhaler use by patients.
We aimed to develop a specific tool for easily assessing and ranking the effectiveness of dry powder inhalers (DPIs) to better characterise these devices, and to help doctors in selecting the most appropriate inhaler for each patient. Based on a systemic review of the pertinent literature we developed a multidimensional grading system score (the Global Inhaler Effectiveness Score, GIES) covering intrinsic characteristics of DPIs and their usability by patients. The GIES consist of two sections – the first section including the following variables: product in vitro performance (emitted dose, induction port deposition, fine particle fraction, performance depending on air flow rate variation) and product features (dose counter, inhalation counter, risk of overtreatment; effect of orientation). The second section includes variables related to usability of the device, i.e. preparation and inhalation errors. Each parameter has been evaluated and a score provided. The sum of the two domains will represent the final GIES; the higher the GIES, the higher the global effectiveness of the device.
The GIES would represent the first comprehensive score for assessing, and ranking objectively the contribution of all main features of DPIs, and then provide an effective and motivated standard of choice.