Effect of the CIS on adherence in poorly controlled asthmatic patients
Research type
Research Study
Full title
An open label, randomised, parallel group clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to Relvar/Breo ELLIPTA therapy, in asthmatic subjects with poor control.
IRAS ID
233093
Contact name
Matthew Capehorn
Contact email
Eudract number
2017-002266-45
Duration of Study in the UK
1 years, 4 months, 14 days
Research summary
In order for a medicine to work effectively patients should take their medicine regularly as prescribed by their doctor. GlaxoSmithKline is conducting a study (207040) in patients with poorly controlled asthma to see what effect a Connected Inhaler System could have on adherence to the Relvar Ellipta inhaler. Approximately 432 patients will take part in this study in 8 countries (approximately 52 patients in the UK).\nPatients entering the study will receive Relvar ELLIPTA (fluticasone furoate/vilanterol) dry powder inhaler (DPI) instead of their usual maintenance therapy, and salbutamol metered dose inhaler (MDI) as rescue medication (to be taken when experiencing symptoms as per standard practice). Relvar ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (to reduce inflammation in the lungs) and vilanterol, a long acting Beta2 agonist (to relax the airways). Relvar ELLIPTA has already been approved by the regulators to treat patients with asthma.\nAll subjects will have sensors which are clipped on to their Relvar Ellipta and Salbutamol inhalers. This can provide data to the patient (via an app to a smart phone) and their doctor (via a dashboard) about how often the patient takes these inhalers. This system is called the Connected Inhaler System and patients will receive training on the system. The study will compare 5 treatment groups which vary based on who can see the data; no one, the patient, the doctor or both the patient and their doctor.\nPatients will be in the study for 7-9 months in total during which they will attend 5-11 study visits.\n• Screening visit: consent, full medical history, questionnaires and physical examination\n• Study visits: safety assessment, questionnaires, lung function test (Peak Expiratory Flow (PEF) and Fractional exhaled Nitric Oxide (FeNO))\n• End of study interview\n• Female subjects will also need to do urine pregnancy tests throughout the study.\n\n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
18/YH/0003
Date of REC Opinion
1 Mar 2018
REC opinion
Further Information Favourable Opinion