Ambulatory measurements of FEV1 in moderate Asthma
Research type
Research Study
Full title
A pilot study to evaluate ambulatory measurement of FEV-1 and other measures of lung function in adult patient volunteers with moderate asthma
IRAS ID
197997
Contact name
Sukh Dave Singh
Contact email
Sponsor organisation
Medicines Evaluation Unit Ltd
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
Measurements of lung function are commonly used to monitor patients with asthma with forced expiratory volume in one second (FEV1) being the gold standard in clinical care and research practice. Measuring lung volumes is common at the GP, in hospital and for research. Asthma is a condition strongly associated with ‘time of day’, which may result in changes in lung function at different times of the day. In this study we are interested in monitoring lung function when measured at home as well as how it is usually measured by health care and research staff. The purpose of this study is to analyse lung function measurements at different times of the day and done at home or in the clinic to assess the differences. The study involves approximately 6 visits to the unit over approximately 6 weeks. The subject will also use an ‘at home’ spirometry device 2-3 times daily, complete a weekly ACQ-6 questionnaire and record inhaler use on a smartphone application between visits. This study will require 12 moderate asthmatic subjects medicated with inhaled corticosteroids (ICS) or ICS plus secondary controllers to complete all study visits.
REC name
London - Bromley Research Ethics Committee
REC reference
16/LO/1474
Date of REC Opinion
4 Aug 2016
REC opinion
Favourable Opinion