INCLINE study
Research type
Research Study
Full title
An Observational Cohort Study of Inhaler Adherence and Blood Eosinophil Count in Exacerbations of Chronic Obstructive Pulmonary Disease
IRAS ID
322749
Contact name
Neil Greening
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
An estimated 65 million people have moderate to severe chronic airway disease worldwide. Inhaled therapy is the cornerstone of treatment. One of the barriers to the management is that patients have to maintain engagement with their inhaler treatment precisely to what is prescribed by the treating physicians. Therefore, one avenue for improving the management of chronic airway diseases is understanding how patients tend to use medication and the factors that influence the usage. Subsequently, we are hoping to identify the changes in body mechanisms, especially blood biomarkers caused by the way patients comply with their treatment.
Overall, this study is to investigate the patients’ inhaler usage and its influence on inflammatory biomarkers. To do this, the study team will provide you with a sensor to attach your usual inhalers which will then be connected to the smartphone app. The app is designed to help with more frequent monitoring of symptoms and adherence to medication use.
The study also would like to collect information regarding participants' weekly symptom burden, quality of life impacted by airway disease by using questionnaires and biological samples such as blood, urine, sputum and swab samples from the nose. This will enable us to understand an individual's body reaction during stable and flare-up stages.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
23/YH/0041
Date of REC Opinion
21 Mar 2023
REC opinion
Further Information Favourable Opinion