The Asthma Breathing Record Study

Asthma Clinical Trial

— ABRS  

Official title:

A Longitudinal, Observational Study to Explore the Tidal Breathing Carbon Dioxide (TBCO2) Waveform, Measured Using the N-Tidal C Device, in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504838
• Other study ID #: PHT/2019/26
• Secondary ID: 37872
• Status: Completed
• Start date: February 11, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: June 2022
• Source: Cambridge Respiratory Innovations Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study involves a new device, called 'N-Tidal C', which uses a method that has the potential to predict when asthma attacks are about to happen. The device works by accurately measuring an individual's exhaled CO2 waveform. A person has to breathe in and out through the mouthpiece at their normal relaxed rate of breathing. It does not need any extra effort and therefore has considerable benefits over current breathing tests which require significant patient effort.

Description:

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. A new tool is needed 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. This study will evaluate 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. The investigators 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 31, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

1. Male or Female, aged =7 years.

2. Confirmed clinician diagnosis of asthma by examination of medical records, and based on accepted national and/or international criteria e.g. BTS/SIGN, or GINA.

3. Moderate or Severe asthma (defined as BTS stage 2-5)

4. Poorly controlled asthma (defined as an ACQ score of =1)

5. Exacerbation prone asthma (defined as at least 1 asthma exacerbation requiring oral corticosteroid treatment in the last 12 months).

6. Providing written informed consent, or parental/guardian consent and participant assent in the case of a child

Exclusion Criteria:

1. Inability to understand or comply with study procedures and/or inability to give fully informed consent.

2. Known other lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would affect spirometry and/or other measures of lung function or TBCO2 measurements (including Breathing Pattern Disorder or Chronic Obstructive Pulmonary Disease).

3. Smokers (current or ex-smokers) with a >10 pack year history.

4. In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently (for example, difficulty holding the device, or long periods of absence/travel) throughout the study period.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth	Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Cambridge Respiratory Innovations Limited	National Institute for Health Research, United Kingdom, Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tidal Breathing Carbon Dioxide (TBCO2) breath records measured by the N-Tidal C data collector device.	To collect Tidal Breathing Carbon Dioxide (TBCO2) breath records, twice daily per participant, which will be correlated to patient reported outcomes and clinical assessments.	From baseline until study completion, up to 12 months.
Secondary	Disease Control in asthma patients	Asthma Control Questionnaire (ACQ) (0= no impairment 6 = maximum impairment)	From baseline until study completion, up to 12 months.
Secondary	Quality of Life	Asthma Quality of Life Questionnaire (AQLQ) 7 = not impaired at all - 1 = severely impaired	From baseline until study completion, up to 12 months.
Secondary	Usability and Acceptability of the device	Visual Analogue Scale (VAS) (7=easy to use - 28=difficult to use)	From baseline until study completion, up to 12 months.
Secondary	Impact on work activity of the device within asthma population	Work Productivity and Activity Impairment Questionnaire (WPAI): Asthma (1=employed - 5= health affected productivity while working)	From baseline until study completion, up to 12 months.