AsthmaGBRSNCT03356288
The General Breathing Record Study
An observational study of Asthma and Heart Failure, run by TidalSense at 1 site in United Kingdom.
Trial summary
This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness. It will also evaluate whether this device can detect when a person's breathing problem is getting worse. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, Heart Failure, Pneumonia
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Aug 2017to 4 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The healthy Cohort will be made up of healthy volunteers. The Disease Cohorts will be selected from hospital outpatient clinic lists and inpatient wards.
Who may be able to join
- Asthma Cohort:
- A confirmed clinical diagnosis of asthma for ≥ 6months
- Moderate to severe asthma defined as British Thoracic Society stages 3-5
- 2 or more exacerbations in the previous 12 months with at least 1 exacerbation within the last 6 months.
- Exacerbation free for 2 weeks (defined as no increased dose or course of oral corticosteroids or antibiotics).
- Breathing Pattern Disorder Cohort
Show all 20Show fewer
- A Clinical diagnosis of a Breathing Pattern Disorder (BPD)
- Chronic heart failure Cohort:
- A confirmed clinical diagnosis of chronic heart failure with both of the following:
- A Left Ventricular Ejection Fraction <40% on most recent imaging within the last 12 months.
- New York Heart Association Class 2-4
- Admitted with an acute decompensation of their heart failure to hospital within the last 6 months
- Motor Neurone Disease Cohort:
- A confirmed clinical diagnosis of Motor Neurone Disease
- Forced Vital Capacity (FVC) of less than 60% of predicted, sleep disordered breathing or daytime hypercapnia.
- Established on Home Non-Invasive Ventilation.
- Pneumonia Cohort:
- A confirmed clinical diagnosis of Pneumonia supported by evidence of consolidation on a chest X-ray (CXR) or computed tomography (CT) imaging.
- Healthy Cohort:
- No known history of lung, cardiac or neuromuscular disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung, cardiac or neuromuscular disease). A Body Mass Index of less than 40. A Non-smoker, or an ex-smoker with less than a 5 pack year history.
Who cannot join
- Known other lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would affect spirometry and/or other measures of lung function or Tidal Breath Carbon Dioxide measurements.
- In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently over the course of 6 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: An Observational Proof-of-concept Study to Explore the Waveform Characteristics of Tidal Breathing Carbon Dioxide (CO2), Measured Using the N-Tidal C™ Device, in Different Breathing Conditions.
This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness. It will also evaluate whether this device can detect when a person's breathing problem is getting worse.
Read the detailed description
When a person breathes out, they exhale carbon dioxide (CO2). The CO2 levels in breath change as they breathe out and this makes a specific pattern, or "waveform". This waveform can tell a clinician a lot about the underlying health of a person. There are disease specific CO2 waveforms for common breathing conditions such as Asthma and Chronic Obstructive Pulmonary Disease (COPD). However up until this point there has been no accurate and non-invasive method of measuring the tidal breath CO2 waveform.
This study will test the N-Tidal C, a new handheld device that accurately measures this waveform, and whether it can differentiate different causes of breathlessness; namely asthma, heart failure, pneumonia, breathing pattern disorders and motor neurone disease.
- Conditions
- Asthma, Heart Failure, Pneumonia, Motor Neuron Disease, Vocal Cord Dysfunction, Breathlessness
- Keywords
- Capnography, Diagnosis. Breathlessness, Exacerbations, Device
- Medical subject headings
- Asthma, Heart Failure, Pneumonia, Motor Neuron Disease, Vocal Cord Dysfunction, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma | 20 Participants with moderate to severe asthma, as defined by British Thoracic Society (BTS) guidelines | |
| Chronic heart failure | 10 Participants with a diagnosis of chronic heart failure | |
| Breathing Pattern Disorder | 10 Participants with a diagnosis of Breathing Pattern Disorder | |
| Pneumonia | 10 participants with a radiologically confirmed diagnosis of pneumonia | |
| Motor Neurone Disease | 10 participants with a diagnosis of motor neurone disease with known hypercapnic failure. | |
| Healthy | 10 Participants who have no known lung, cardiac or neuromuscular condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The tidal breathing carbon dioxide waveform for each of the breathing conditions as measured by the N-Tidal C device
Measured: 12 months
Secondary outcomes (8)
Change in the Tidal Breathing carbon dioxide waveform over time
Change in the tidal breathing carbon dioxide waveform, in each disease, over the 6 months.
Measured: Change measures - baseline to 6 months
Disease Control in asthma patients
The Asthma Control Questionnaire Score for the Asthma patients
Measured: 12 months
Disease Improvement in Breathing Pattern Disorder patients
The Nijmegen Questionnaire Score
Measured: 12 months
Disease severity in the pneumonia patients
The CURB-65 Score
Measured: 2 days
Disease severity in heart failure patients
The Trans Thoracic Echocardiogram (TTE) result
Measured: 12 months
Hypercapnia in the motor neurone disease patients
The level of partial pressure carbon dioxide (pCO2)
Measured: 12 months
Usability of the N-Tidal C device
Measured by how frequently the patients remember to use the N-Tidal C device over 6 months
Measured: Change measures - baseline to 6 months
Acceptability of the N-Tidal C device
Measured by a questionnaire of the participants experience of the device at the end of the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start9 Aug 2017
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- TidalSense
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovate UK
- Responsible party
- Sponsor
- Investigators
- Anoop J Chauhan, PhD, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356288
- Sponsor's protocol ID
- G002-17_GBRS
- Acronym
- GBRS
- Status last verified
- Sep 2018
- First submitted
- 7 Sep 2017
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Neville DM, Lim RH, Hawke E, Talker L, Broomfield H, Dogan C, Selim AB, Lambert G, Carter JC, Begum S, De Vos R, Kalra P, Quint M, Adeniji K, Brown TP, Patel AX, Chauhan AJ. Breath-by-breath: unmasking cardio-respiratory conditions through capnography waveforms - the general breathing record study. Eur Clin Respir J. 2026 May 25;13(1):2661529. doi: 10.1080/20018525.2026.2661529. eCollection 2026.
PubMed 42205504Talker L, Neville D, Wiffen L, Selim AB, Haines M, Carter JC, Broomfield H, Lim RH, Lambert G; BRS Study Team; Weiss ST, Hayward G, Brown T, Chauhan A, Patel AX. Machine diagnosis of chronic obstructive pulmonary disease using a novel fast-response capnometer. Respir Res. 2023 Jun 2;24(1):150. doi: 10.1186/s12931-023-02460-z.
PubMed 37268935
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Proof-of-concept Study to Explore the Waveform Characteristics of Tidal Breathing Carbon Dioxide (CO2), Measured Using the N-Tidal C™ Device, in Different Breathing Conditions.
- ClinicalTrials.gov ID
- NCT03356288
- Acronym / sponsor ID
- GBRS / G002-17_GBRS
- Conditions
- Asthma, Heart Failure, Pneumonia, Motor Neuron Disease, Vocal Cord Dysfunction, Breathlessness
- Keywords
- Capnography, Diagnosis. Breathlessness, Exacerbations, Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- TidalSenseIndustry (pharma, biotech, devices)
- Collaborators
- Innovate UK
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness. It will also evaluate whether this device can detect when a person's breathing problem is getting worse.
Detailed description
When a person breathes out, they exhale carbon dioxide (CO2). The CO2 levels in breath change as they breathe out and this makes a specific pattern, or "waveform". This waveform can tell a clinician a lot about the underlying health of a person. There are disease specific CO2 waveforms for common breathing conditions such as Asthma and Chronic Obstructive Pulmonary Disease (COPD). However up until this point there has been no accurate and non-invasive method of measuring the tidal breath CO2 waveform.
This study will test the N-Tidal C, a new handheld device that accurately measures this waveform, and whether it can differentiate different causes of breathlessness; namely asthma, heart failure, pneumonia, breathing pattern disorders and motor neurone disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | –20 Participants with moderate to severe asthma, as defined by British Thoracic Society (BTS) guidelines |
| Chronic heart failure | – | –10 Participants with a diagnosis of chronic heart failure |
| Breathing Pattern Disorder | – | –10 Participants with a diagnosis of Breathing Pattern Disorder |
| Pneumonia | – | –10 participants with a radiologically confirmed diagnosis of pneumonia |
| Motor Neurone Disease | – | –10 participants with a diagnosis of motor neurone disease with known hypercapnic failure. |
| Healthy | – | –10 Participants who have no known lung, cardiac or neuromuscular condition. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The healthy Cohort will be made up of healthy volunteers. The Disease Cohorts will be selected from hospital outpatient clinic lists and inpatient wards.
Key inclusion criteria (20 listed)
- A confirmed clinical diagnosis of asthma for ≥ 6months
- Moderate to severe asthma defined as British Thoracic Society stages 3-5
- 2 or more exacerbations in the previous 12 months with at least 1 exacerbation within the last 6 months.
- Exacerbation free for 2 weeks (defined as no increased dose or course of oral corticosteroids or antibiotics).
- Breathing Pattern Disorder Cohort
Key exclusion criteria (2 listed)
- Known other lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would affect spirometry and/or other measures of lung function or Tidal Breath Carbon Dioxide measurements.
- In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently over the course of 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The tidal breathing carbon dioxide waveform for each of the breathing conditions as measured by the N-Tidal C device
Time frame: 12 months
8 secondary outcomes
Change in the Tidal Breathing carbon dioxide waveform over time
Time frame: Change measures - baseline to 6 months
Disease Control in asthma patients
Time frame: 12 months
Disease Improvement in Breathing Pattern Disorder patients
Time frame: 12 months
Disease severity in the pneumonia patients
Time frame: 2 days
Disease severity in heart failure patients
Time frame: 12 months
Hypercapnia in the motor neurone disease patients
Time frame: 12 months
Usability of the N-Tidal C device
Time frame: Change measures - baseline to 6 months
Acceptability of the N-Tidal C device
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Derived from this study: PubMed 42205504Neville DM, Lim RH, Hawke E, Talker L, Broomfield H, Dogan C, Selim AB, Lambert G, Carter JC, Begum S, De Vos R, Kalra P, Quint M, Adeniji K, Brown TP, Patel AX, Chauhan AJ. Breath-by-breath: unmasking cardio-respiratory conditions through capnography waveforms - the general breathing record study. Eur Clin Respir J. 2026 May 25;13(1):2661529. doi: 10.1080/20018525.2026.2661529. eCollection 2026.
- Derived from this study: PubMed 37268935Talker L, Neville D, Wiffen L, Selim AB, Haines M, Carter JC, Broomfield H, Lim RH, Lambert G; BRS Study Team; Weiss ST, Hayward G, Brown T, Chauhan A, Patel AX. Machine diagnosis of chronic obstructive pulmonary disease using a novel fast-response capnometer. Respir Res. 2023 Jun 2;24(1):150. doi: 10.1186/s12931-023-02460-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anoop J Chauhan, PhD principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Heart Failure, run by TidalSense at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The tidal breathing carbon dioxide waveform for each of the breathing conditions as measured by the N-Tidal C device (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03356288, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.