Chronic Obstructive Pulmonary DiseaseCBRS2NCT03615365
COPD Breathing Record Study 2
An observational study of Chronic Obstructive Pulmonary Disease, run by TidalSense at 1 site in United Kingdom.
Trial summary
The aim of this study is to collect capnometric (tidal breathing CO2) data using TidalSense's N-Tidal C Data Collector Device. The data collected will be examined for correlation with currently accepted assessment techniques for COPD (spirometry, vital signs and pulse oximetry) and the patient's clinical condition… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2017to 23 Nov 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) will be identified from the Cambridge COPD Centre. Those patients with COPD satisfying the inclusion criteria will be invited to participate. The majority of these will be GOLD D.
Who may be able to join
- Aged 40 years and over.
- Diagnosis of COPD (Primary) and at least one moderate exacerbation within 12 months of the start of the study period.
- Able to provide signed informed consent.
Who cannot join
- Patients who, in the opinion of the investigator, are unlikely to comply with the requirements of the study, use the device correctly or keep the diary records;
- Diagnosis of neuromuscular disorders or Kyphoscoliosis;
- Diagnosis of other Respiratory disorders that, in the opinion of the investigator, would impact the conduct of the study e.g. clinically significant bronchiectasis, asthma;
- Patients who have experienced an exacerbation of their COPD that has required treatment with antibiotics and/or oral corticosteroids within 2 weeks prior to the study start.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB24 5AA
About this study
Official title: Characterisation of COPD Breathing Records During Exacerbations
The aim of this study is to collect capnometric (tidal breathing CO2) data using TidalSense's N-Tidal C Data Collector Device. The data collected will be examined for correlation with currently accepted assessment techniques for COPD (spirometry, vital signs and pulse oximetry) and the patient's clinical condition (stable, worsening, improving). The patient numbers and study duration have been determined by power calculations to provide a statistically significant sample size, based on expected number of exacerbations (mild, moderate and severe) from the patient cohort. The data will also be examined to assess the predictive possibility of a non-invasive self-care personal CO2 monitoring device to identify COPD exacerbations.
Read the detailed description
Study Design: This is an uncontrolled, non-randomised, un-blinded longitudinal observational data collection study with the N-Tidal C Data Collector Device in patients with COPD.
Patients will be identified from the Cambridge COPD Centre. This unit sees patients following emergency admissions, GP referrals and has a regional referral base for complex COPD. Patients' medical records will be reviewed and classified according to GOLD criteria. Those patients who are classified as COPD with appropriate inclusion criteria (below) will be invited to participate. Patients who give informed consent will be screened for the study.
The N-Tidal C Data Collector Device will be explained to the patients and they will be trained how to use it. All patients will complete a short daily diary record.
Patients will undergo a clinical assessment of COPD during screening at Addenbrooke's Hospital. All patients will be assessed five times: at the start, 2 weeks, 10 weeks, 18 weeks and at the end of the 26 week study period. A brief follow-up telephone review will be conducted approximately 2 weeks after the end of the monitoring period. At each assessment, capnometry measurements will be taken in addition to vital signs and pulse oximetry. The study will not interfere with routine management of the patient's condition.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Capnography, Diagnosis, Breathlessness, Exacerbations, Device
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Disease, 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 |
|---|---|---|
| Patients with moderate-to-severe COPD. | Patients will be identified from the Cambridge COPD Centre. This unit sees patients following emergency admissions, GP referrals and has a regional referral base for complex COPD. Patients' medical records will be reviewed and classified according to GOLD criteria. Patients will undergo a clinical assessment of COPD during screening at Addenbrooke's Hospital. All patients will be assessed five times: at the start, 2 weeks, 10 weeks, 18 weeks and at the end of the 26 week study period. A brief follow-up telephone review will be conducted approximately 2 weeks after the end of the monitoring period. At each assessment, capnometry measurements will be taken in addition to vital signs and pulse oximetry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the changes in the α angle of the tidal breathing CO2 (TBCO2) waveform data from stable COPD through an exacerbation and back to stable.
The α angle is one of the key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device.
The α angle is given in degrees and significant changes in the α angle have previously been observed between stable COPD and acute exacerbations of COPD.
Measured: Throughout the 26 week use of the N-Tidal C device for each patient.
To measure the minimum and maximum CO2 levels of the TBCO2 waveform data from stable COPD through an exacerbation and back to stable.
The minimum and maximum CO2 levels are key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device.
CO2 levels are given in kPa and significant differences have previously been observed between stable COPD and acute exacerbations of COPD.
Measured: Throughout the 26 week use of the N-Tidal C device for each patient.
To measure the variability of breath length of the TBCO2 waveform data from stable COPD through an exacerbation and back to stable.
The variability of breath length is one of the key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device.
Breath length is measured in seconds and significant differences have previously been observed between stable COPD and acute exacerbations of COPD.
Measured: Throughout the 26 week use of the N-Tidal C device for each patient.
To measure the standard deviation of End Tidal CO2 levels of the TBCO2 waveform data from stable COPD through an exacerbation and back to stable.
The standard deviation of End Tidal CO2 levels is one of the key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device.
End Tidal CO2 levels are given in kPa and significant differences have previously been observed between stable COPD and acute exacerbations of COPD.
Measured: Throughout the 26 week use of the N-Tidal C device for each patient.
Secondary outcomes (5)
Longitudinal Database
To collect a longitudinal observational database of TBCO2 waveform records for up to 50 patients with COPD over a period of 26 weeks using the N-Tidal C device.
Measured: Throughout the 26 week use of the N-Tidal C device for each patient.
COPD Exacerbations
To capture the carbon dioxide signature predictive of exacerbations in monitored patients who undergo mild, moderate and severe exacerbations during the study.
Measured: Throughout the 26 week use of the N-Tidal C device for each patient.
COPD Variability
To identify the within-day and day-to-day variability of respired CO2 in patients with COPD
Measured: Throughout the 26 week use of the N-Tidal C device for each patient.
Usability of the N-Tidal C device
Measured by the patients compliance and perseverance to the use the N-Tidal C device.
Measured: Throughout the 26 week use of the N-Tidal C device for each patient.
Acceptability of the N-Tidal C device
The patients will be asked questions about the ease of use of the N-Tidal C and twice daily respiratory monitoring.
Measured: At the end of the 26 week use of the N-Tidal C device for each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start15 Aug 2017
- Primary completion18 Oct 2018
- Study completion23 Nov 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 Chronic Obstructive Pulmonary DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TidalSense
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravi Mahadeva, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615365
- Sponsor's protocol ID
- G007-17_CBRS2
- Acronym
- CBRS2
- Status last verified
- Nov 2018
- First submitted
- 19 Jul 2018
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lim RH, Talker L, Broomfield H, Dogan C, Selim AB, Lambert G, Carter JC, Neville DM, Wiffen L, Brown T; BRS Team; Vijaykumar E, Chauhan AJ, Patel AX. Quantification of smoking-related airway remodelling in COPD, using N-Tidal. Sci Rep. 2026 Feb 26;16(1):8713. doi: 10.1038/s41598-026-41699-6.
PubMed 41748706Talker 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 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of COPD Breathing Records During Exacerbations
- ClinicalTrials.gov ID
- NCT03615365
- Acronym / sponsor ID
- CBRS2 / G007-17_CBRS2
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Capnography, Diagnosis, Breathlessness, Exacerbations, Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TidalSenseIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 23 Nov 2018 (actual)
- First posted
- 3 Aug 2018 (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.
The aim of this study is to collect capnometric (tidal breathing CO2) data using TidalSense's N-Tidal C Data Collector Device. The data collected will be examined for correlation with currently accepted assessment techniques for COPD (spirometry, vital signs and pulse oximetry) and the patient's clinical condition (stable, worsening, improving). The patient numbers and study duration have been determined by power calculations to provide a statistically significant sample size, based on expected number of exacerbations (mild, moderate and severe) from the patient cohort. The data will also be examined to assess the predictive possibility of a non-invasive self-care personal CO2 monitoring device to identify COPD exacerbations.
Detailed description
Study Design: This is an uncontrolled, non-randomised, un-blinded longitudinal observational data collection study with the N-Tidal C Data Collector Device in patients with COPD.
Patients will be identified from the Cambridge COPD Centre. This unit sees patients following emergency admissions, GP referrals and has a regional referral base for complex COPD. Patients' medical records will be reviewed and classified according to GOLD criteria. Those patients who are classified as COPD with appropriate inclusion criteria (below) will be invited to participate. Patients who give informed consent will be screened for the study.
The N-Tidal C Data Collector Device will be explained to the patients and they will be trained how to use it. All patients will complete a short daily diary record.
Patients will undergo a clinical assessment of COPD during screening at Addenbrooke's Hospital. All patients will be assessed five times: at the start, 2 weeks, 10 weeks, 18 weeks and at the end of the 26 week study period. A brief follow-up telephone review will be conducted approximately 2 weeks after the end of the monitoring period. At each assessment, capnometry measurements will be taken in addition to vital signs and pulse oximetry. The study will not interfere with routine management of the patient's condition.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with moderate-to-severe COPD. | – | –Patients will be identified from the Cambridge COPD Centre. This unit sees patients following emergency admissions, GP referrals and has a regional referral base for complex COPD. Patients' medical records will be reviewed and classified according to GOLD criteria. Patients will undergo a clinical assessment of COPD during screening at Addenbrooke's Hospital. All patients will be assessed five times: at the start, 2 weeks, 10 weeks, 18 weeks and at the end of the 26 week study period. A brief follow-up telephone review will be conducted approximately 2 weeks after the end of the monitoring period. At each assessment, capnometry measurements will be taken in addition to vital signs and pulse oximetry. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) will be identified from the Cambridge COPD Centre. Those patients with COPD satisfying the inclusion criteria will be invited to participate. The majority of these will be GOLD D.
Key inclusion criteria (3 listed)
- Aged 40 years and over.
- Diagnosis of COPD (Primary) and at least one moderate exacerbation within 12 months of the start of the study period.
- Able to provide signed informed consent.
Key exclusion criteria (4 listed)
- Patients who, in the opinion of the investigator, are unlikely to comply with the requirements of the study, use the device correctly or keep the diary records;
- Diagnosis of neuromuscular disorders or Kyphoscoliosis;
- Diagnosis of other Respiratory disorders that, in the opinion of the investigator, would impact the conduct of the study e.g. clinically significant bronchiectasis, asthma;
- Patients who have experienced an exacerbation of their COPD that has required treatment with antibiotics and/or oral corticosteroids within 2 weeks prior to the study start.
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
To measure the changes in the α angle of the tidal breathing CO2 (TBCO2) waveform data from stable COPD through an exacerbation and back to stable.
Time frame: Throughout the 26 week use of the N-Tidal C device for each patient.
The α angle is one of the key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device. The α angle is given in degrees and significant changes in the α angle have previously been observed between stable COPD and acute exacerbations of COPD.
To measure the minimum and maximum CO2 levels of the TBCO2 waveform data from stable COPD through an exacerbation and back to stable.
Time frame: Throughout the 26 week use of the N-Tidal C device for each patient.
The minimum and maximum CO2 levels are key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device. CO2 levels are given in kPa and significant differences have previously been observed between stable COPD and acute exacerbations of COPD.
To measure the variability of breath length of the TBCO2 waveform data from stable COPD through an exacerbation and back to stable.
Time frame: Throughout the 26 week use of the N-Tidal C device for each patient.
The variability of breath length is one of the key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device. Breath length is measured in seconds and significant differences have previously been observed between stable COPD and acute exacerbations of COPD.
To measure the standard deviation of End Tidal CO2 levels of the TBCO2 waveform data from stable COPD through an exacerbation and back to stable.
Time frame: Throughout the 26 week use of the N-Tidal C device for each patient.
The standard deviation of End Tidal CO2 levels is one of the key parameters extracted from the TBCO2 waveform data captured by the N-Tidal C device. End Tidal CO2 levels are given in kPa and significant differences have previously been observed between stable COPD and acute exacerbations of COPD.
5 secondary outcomes
Longitudinal Database
Time frame: Throughout the 26 week use of the N-Tidal C device for each patient.
COPD Exacerbations
Time frame: Throughout the 26 week use of the N-Tidal C device for each patient.
COPD Variability
Time frame: Throughout the 26 week use of the N-Tidal C device for each patient.
Usability of the N-Tidal C device
Time frame: Throughout the 26 week use of the N-Tidal C device for each patient.
Acceptability of the N-Tidal C device
Time frame: At the end of the 26 week use of the N-Tidal C device for each patient.
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 2 Jun 2023.
- Derived from this study: PubMed 41748706Lim RH, Talker L, Broomfield H, Dogan C, Selim AB, Lambert G, Carter JC, Neville DM, Wiffen L, Brown T; BRS Team; Vijaykumar E, Chauhan AJ, Patel AX. Quantification of smoking-related airway remodelling in COPD, using N-Tidal. Sci Rep. 2026 Feb 26;16(1):8713. doi: 10.1038/s41598-026-41699-6.
- 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.
- Individual participant dataSharing planned: Yes
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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.
Ravi Mahadeva principal investigator
Cambridge University Hospitals NHS Foundation 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 Chronic Obstructive Pulmonary Disease, 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 3 inclusion and 4 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 2 Jun 2023. 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?
To measure the changes in the α angle of the tidal breathing CO2 (TBCO2) waveform data from stable COPD through an exacerbation and back to stable. (time frame: Throughout the 26 week use of the N-Tidal C device for each patient.). The study lists 4 primary outcomes in all. 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 NCT03615365, 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 2 Jun 2023.