e-Module Validation in Clinic - eMViC
Research type
Research Study
Full title
A Single Visit, Open-Label Study of the Accuracy of Measurement of the Maximum Inhalation Flow (MIF) of Patients With Asthma or COPD Using an Electronic Multi-dose Dry Powder Inhaler (eMDPI)
IRAS ID
200012
Contact name
Henry Chrystyn
Contact email
Sponsor organisation
Teva Pharmaceuticals
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Electronic monitors linked to Bluetooth Technology can be placed inside an inhaler without affecting its performance. An empty Spiromax (RepiClick in the USA) has been fitted with an e-module. This electronic multidose dry powder inhaler (eMDPI) can make measurements when a dose was inhaled, give feedback on the type of inhalation made and could use these measurements to monitor the lung disease control of the user. \nIt is essential to identify the accuracy of the eMDPI to measure the type of inhalation when the device is used by patients. This is measured as an inhalation profile which identifies the inhalation flow against time during each inhalation manoeuvre. The measurements, from this profile, are the maximum speed of each inhalation (maximum inhalation flow), the volume of air inhaled, the length of the inhalation and the time to reach the fastest inhaled flow. These are the inhalation parameters.\nPatients with asthma or chronic obstructive pulmonary disease will attend the clinic for a single visit. They will have their vital signs measured (heart rate, blood pressure and temperature) as well as spirometry lung function measurement, complete questionnaires and be trained the recommended inhalation manoeuvre when using the eMDPI according to instructions in the Instruction For Use provided by the manufacturer. When trained they will make three separate inhalations using the eMDPI with a two minute break between each inhalation. Their vital signs will be re-measured and when the same as baseline the study visit will end. They will be telephoned the next day to ask how they were after the visit.\nThe inhalation parameters will be measured by the eMDPI and by standard methods using an inhalation profile recorder. The two measurements will be compared to identify the accuracy of the eMDPI to measure the inhalation parameters\n \n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
16/YH/0346
Date of REC Opinion
9 Nov 2016
REC opinion
Further Information Favourable Opinion