Evaluating a new type of lung function test device in primary care
Research type
Research Study
Full title
Phase1 clinical trial for first evaluation of a new type of lung function test device in primary care
IRAS ID
132964
Contact name
David Hitchings
Contact email
Sponsor organisation
MidStaffordshire Chest Diseses Fund. Charity no 1023916
Research summary
In 1993, UK Patent Application (GB 2270470A) was filed on a new type of peak expiratory flow meter. A prototype built by Dr. Hitchings had a faster response than conventional peak flow meters, so measured peak flow was less distorted\nthan with conventional meters. It used a flap valve that was closed when a patient first tried to breathe hard into it and maximum expiratory pressure was measured. Then, in following tests for each person, the valve was suddenly opened at a predetermined pressure set at 80% of that maximum and the patient blew out hard through the device. Such a rapid falloff in pressure at the mouth to atmospheric pressure is equivalent to a voluntary coughing manoeuvre and was followed by a maximal breath out, continued to a residual volume. It was so used in a very small “proofofconcept” clinical trial.\nStatistical analysis of unpublished trial results appeared to show that the drop in expiratory flow rate was much faster in people with emphysema than those with no breathing problems or even those with asthma.\nThis encouraged us to develop a new prototype, which responds much faster and more accurately than the initial device, making several thousand flow rate measurements per second.\nWe propose conducting Phase 1 clinical trials of our new device, in a Primary Care context, with a healthy, nonsmoking control group of volunteers and blindly analysing healthy volunteers who smoke and groups of patients with already identified respiratory diseases (asthma, emphysema, other COPD, various pulmonary restrictive and fibrotic diseases). We will measure maximum expiratory pressure, maximum expiratory flow rate, time to half peak flow rate and new parameters (see A62) derived from the detailed breath flow records. Using multivariate statistical analyses, we will investigate how these enable us to classify people into different functional categories.\n
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
13/WM/0250
Date of REC Opinion
2 Aug 2013
REC opinion
Further Information Favourable Opinion