The Asthma Breathing Record Study (ABRS)

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Portsmouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with poorly controlled asthma

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control in asthma patients	Asthma Control Questionnaire (ACQ) (0= no impairment 6 = maximum impairment)	From baseline until study completion, up to 12 months.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Cambridge Respiratory Innovations Limited
• Collaborators: National Institute for Health Research, United Kingdom; Portsmouth Hospitals NHS Trust
• Investigators: Principal Investigator: Anoop Chauhan, Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Actual): January 20, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: PHT/2019/26; 37872 (Other Identifier: ISRCTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No