The Asthma Breathing Record Study (ABRS)
Research type
Research Study
Full title
A longitudinal, observational study to explore the Tidal Breathing Carbon Dioxide (TBCO2) waveform, measured using the N-Tidal C device, in asthma.
IRAS ID
262873
Contact name
Anoop Chauhan
Contact email
Sponsor organisation
Cambridge Respiratory Innovations Ltd
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
People with more severe asthma suffer from frequent asthma attacks that require regular hospital admissions. These attacks are difficult to predict and can devastate the lives of patients. We need a new tool that can help to predict when an asthma attack is going to happen. This would help people recognise an attack earlier and allow treatment to be started sooner. We will study a new breathing monitor, to see whether it can detect asthma attacks.
The study tests a new device, called ‘N-Tidal C’, which uses a method that has the potential to predict when attacks are about to happen. We have found that people with asthma breathe out a gas, called carbon dioxide (CO2), in a different way to healthy people. The pattern of breathing out CO2 (the waveform) changes further when patients are having an attack of their disease. If patients could monitor their CO2, they may recognise when their asthma is getting worse, and take earlier action to avoid attacks getting out of hand and going to hospital. We need to test the device in people with asthma to see whether it can detect asthma attacks accurately and early.To investigate the data collected by the N-Tidal C device, we will perform the following study:
We will recruit 140 people, including 30 children, with known poorly controlled asthma. Participants will be recruited from primary and secondary care clinics at Portsmouth Hospitals NHS Trust, GP surgeries in Hampshire, and GP surgeries in Thames Valley.
All participants in the study will get their own N-Tidal C device. We will collect the necessary information about each participant such as their weight, height, their current medication and health problems. The participant will be asked to fill out questionnaires about their asthma, how bad it is and how it affects them. They will have standard tests to verify the severity of their asthma. They will then take the N-Tidal C device home and use it twice a day for a period of 6 months (or up to 12 months in the Portsmouth adults group). Each participant will have contact with the research team at follow up visits. Also twice a week they will respond to an automated telephone call or text message provided by Message Dynamics to report any attacks.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0420
Date of REC Opinion
4 Sep 2019
REC opinion
Favourable Opinion