Asthma Monitoring Device- Methacholine Challenge Study
Research type
Research Study
Full title
Detection of Methacholine Challenge Induced Asthma Symptoms Using a Novel Device
IRAS ID
212494
Contact name
Lee Brooks
Contact email
Sponsor organisation
Anaxsys Technology Ltd
Duration of Study in the UK
0 years, 4 months, 26 days
Research summary
Is the Anaxsys Asthma Monitoring Device able to detect asthma symptoms in known asthmatics?
Anaxsys is developing a device to monitor asthma symptoms. It will be used by asthma sufferers to help them control their condition. This device will be an alternative to the peak flow meter. The investigational device is a prototype.
Between eight and twenty adults with asthma will take part in a Methacholine challenge test. A Methacholine challenge test measures how sensitive a person is to things that commonly cause asthma symptoms. The patient breathes in a substance called methacholine to see how sensitive their lungs are. To begin the test the patient breathes in a small amount of Methacholine. Their Lung function (how well their lungs work) is then measured using a spirometer. A spirometer is a device which accurately measures lung function. More Methacholine is then breathed in and their lung function measured again. This carries on until they start to have asthma symptoms. The asthma symptoms are then quickly reversed by breathing in a type of drug known as a bronchodilator (salbutamol inhaler). Their lung function is then measured again using a spirometer.
The Methacholine challenge tests in this study will be performed in a single visit of around four hours for each patient. It will take place at the Leicester Respiratory Biomedical Research Unit. Trained healthcare specialists will be in charge of the testing.
The lung function of each patient will be measured using the Anaxsys device after each test with the spirometer. If the spirometer shows that a patient’s lungs are not working as well as they did before the testing started the Anaxsys device must show the same thing.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
16/EE/0372
Date of REC Opinion
6 Oct 2016
REC opinion
Further Information Favourable Opinion