CoughNCT07098793
Cough Monitoring in COPD
An observational study of Cough and COPD, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This is an observational study designed to learn about symptoms of cough and how changes in cough may be associated with the beginning of a COPD exacerbation (acute worsening of symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cough, COPD, COPD Exacerbation
- What is being tested?
- Cough monitoring
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 May 2022to 10 Oct 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with current diagnosis of COPD who have had at least 2 moderate exacerbations of their COPD within the last year
Who may be able to join
- • Clinical diagnosis of COPD using GOLD criteria.
- 2 or more moderate and/or severe exacerbations of COPD in the previous year*.
- Clinical stability (i.e. absence of exacerbation requiring oral corticosteroids and/or antibiotics) for at least 4 weeks prior to enrollment.
- Current or ex-smoker with ≥10 pack-year smoking history
- Provision of informed consent
Who cannot join
- • Children < age of 18
- Failure to provide consent
- Other significant comorbid medical or psychological condition that is deemed by the principal investigator to affect cough frequency or the subject's ability to comply with monitoring procedures.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Redspiratory mMedicine, First Floor, Daisy Building, Castle Hill Hospital
Cottingham, East Yorkshiure, HU16 5JQ
About this study
Official title: Cough Monitoring in COPD:a Mixed Methods Observational Study
This is an observational study designed to learn about symptoms of cough and how changes in cough may be associated with the beginning of a COPD exacerbation (acute worsening of symptoms.
The Investigators are looking to recruit patients diagnosed with COPD who have had two or more exacerbations of their disease within the last year requiring treatment with antibiotics or corticosteroids.
Read more
The main question aimed to be answered is whether the cough monitor can detect changes in a patient's clinical condition.
Patients will be screened for participation in the study and a medical history will be taken alongside details of current medications, height, weight, vital signs as well and smoking status.
The patients will be asked to complete 3 questionnaires and the cough monitor will be installed in the room within their home where they sleep.
Patients will be asked to complete a daily diary for 90 to a maximum of 180 days and leave the monitor recording cough throughout this time.
Read the detailed description
COPD is associated with disabling, progressive symptoms with episodes of rapid worsening termed acute exacerbations (AECOPD). It poses a significant global health challenge with AECOPD often resulting in the use of unscheduled care services including hospital attendance and admission. In addition to trying to prevent AECOPD, strategies have been developed to identify clinical deterioration early prompting intervention in the community with the aim of preventing unscheduled care service utilization.
Telemonitoring refers to the use of technology to monitor patients' clinical condition in their own homes. One of the proposed benefits of telemonitoring is the early detection of clinical deterioration. At present, COPD telemonitoring relies on daily symptom reporting and monitoring of basic physiological data including heart rate and pulse oximetry. However, current strategies lack specificity resulting in difficulty identifying true exacerbations from normal day to day variation.
Cough and sputum production are reported by 60-80% of COPD patients, are increased at the time of exacerbation, and are associated with accelerated lung function decline, frequent exacerbations, and earlier mortality. It has previously been demonstrated that change in cough frequency at the time of exacerbation can be detected using a cough monitor that utilizes cough classifier software to analyse ambient sound. In the context of telemonitoring, this has the potential to facilitate the early detection of clinical change using an objective measure that does not require patient effort.
Remote monitoring of COPD patients in their own homes aims to detect clinical deterioration early prompting intervention in the community with the aim of preventing utilization of unscheduled care services. Current systems do not succeed in reaching this target . A pilot study of remote cough monitoring has demonstrated that cough frequency was significantly increased during COPD exacerbation and trends in cough frequency can be detected using remote microphones and automated cough counting software. In a follow-up study, a cough-based alert system has been constructed showing promising performance. This prospective evaluation will validate the constructed system in a further COPD patient cohort.
- Conditions
- Cough, COPD, COPD Exacerbation
- Being tested
- Cough monitoring
- Medical subject headings
- Cough, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough monitoringDevice
continuous recording of cough in patients sleeping area for 90-180 days
| Study group | Role | What they receive |
|---|---|---|
| patient with COPD | Patients with frequent exacerbations of COPD Receives: Device: Cough monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute exacerbation of COPD alert system performance
the ratio of successful alerts of acute exacerbations of COPD to false positive alerts.
Measured: 90-190 days
Secondary outcomes (3)
number of successfull alerts of Acute exacerbations of COPD
Total number of alerts of acute exacerbations of COPD identified by change in cough
Measured: 90-180 days
Number of False positive alerts of Acute Exacerbation of COPD
Total number of Acute exacerbation alerts detected by monitoring cough that didn't result in a acute exacerbation of COPD
Measured: 90-180 days
correlation cough counts with questionnaire data
correlate Hull airway reflux questionnaire scores, cough visual analgue scale with average cough counts
Measured: 90-180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start18 May 2022
- Primary completion19 Jun 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CoughStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Philips Clinical & Medical Affairs Global
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098793
- Sponsor's protocol ID
- COPD2023
- Status last verified
- Mar 2025
- First submitted
- 5 Sep 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.
PubMed 21115606de Oliveira JC, de Carvalho Aguiar I, de Oliveira Beloto AC, Santos IR, Filho FS, Sampaio LM, Donner CF, Oliveira LV. Clinical significance in COPD patients followed in a real practice. Multidiscip Respir Med. 2013 Jun 28;8(1):43. doi: 10.1186/2049-6958-8-43.
PubMed 23806051Burgel PR, Nesme-Meyer P, Chanez P, Caillaud D, Carre P, Perez T, Roche N; Initiatives Bronchopneumopathie Chronique Obstructive (BPCO) Scientific Committee. Cough and sputum production are associated with frequent exacerbations and hospitalizations in COPD subjects. Chest. 2009 Apr;135(4):975-982. doi: 10.1378/chest.08-2062. Epub 2008 Nov 18.
PubMed 19017866Vestbo J, Prescott E, Lange P. Association of chronic mucus hypersecretion with FEV1 decline and chronic obstructive pulmonary disease morbidity. Copenhagen City Heart Study Group. Am J Respir Crit Care Med. 1996 May;153(5):1530-5. doi: 10.1164/ajrccm.153.5.8630597.
PubMed 8630597Ekberg-Aronsson M, Pehrsson K, Nilsson JA, Nilsson PM, Lofdahl CG. Mortality in GOLD stages of COPD and its dependence on symptoms of chronic bronchitis. Respir Res. 2005 Aug 25;6(1):98. doi: 10.1186/1465-9921-6-98.
PubMed 16120227
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cough Monitoring in COPD:a Mixed Methods Observational Study
- ClinicalTrials.gov ID
- NCT07098793
- Acronym / sponsor ID
- COPD2023
- Conditions
- Cough, COPD, COPD Exacerbation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- Philips Clinical & Medical Affairs Global
- Study start
- 18 May 2022 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 1 Aug 2025 (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 is an observational study designed to learn about symptoms of cough and how changes in cough may be associated with the beginning of a COPD exacerbation (acute worsening of symptoms.
The Investigators are looking to recruit patients diagnosed with COPD who have had two or more exacerbations of their disease within the last year requiring treatment with antibiotics or corticosteroids.
The main question aimed to be answered is whether the cough monitor can detect changes in a patient's clinical condition.
Patients will be screened for participation in the study and a medical history will be taken alongside details of current medications, height, weight, vital signs as well and smoking status.
The patients will be asked to complete 3 questionnaires and the cough monitor will be installed in the room within their home where they sleep.
Patients will be asked to complete a daily diary for 90 to a maximum of 180 days and leave the monitor recording cough throughout this time.
Detailed description
COPD is associated with disabling, progressive symptoms with episodes of rapid worsening termed acute exacerbations (AECOPD). It poses a significant global health challenge with AECOPD often resulting in the use of unscheduled care services including hospital attendance and admission. In addition to trying to prevent AECOPD, strategies have been developed to identify clinical deterioration early prompting intervention in the community with the aim of preventing unscheduled care service utilization.
Telemonitoring refers to the use of technology to monitor patients' clinical condition in their own homes. One of the proposed benefits of telemonitoring is the early detection of clinical deterioration. At present, COPD telemonitoring relies on daily symptom reporting and monitoring of basic physiological data including heart rate and pulse oximetry. However, current strategies lack specificity resulting in difficulty identifying true exacerbations from normal day to day variation.
Cough and sputum production are reported by 60-80% of COPD patients, are increased at the time of exacerbation, and are associated with accelerated lung function decline, frequent exacerbations, and earlier mortality. It has previously been demonstrated that change in cough frequency at the time of exacerbation can be detected using a cough monitor that utilizes cough classifier software to analyse ambient sound. In the context of telemonitoring, this has the potential to facilitate the early detection of clinical change using an objective measure that does not require patient effort.
Remote monitoring of COPD patients in their own homes aims to detect clinical deterioration early prompting intervention in the community with the aim of preventing utilization of unscheduled care services. Current systems do not succeed in reaching this target . A pilot study of remote cough monitoring has demonstrated that cough frequency was significantly increased during COPD exacerbation and trends in cough frequency can be detected using remote microphones and automated cough counting software. In a follow-up study, a cough-based alert system has been constructed showing promising performance. This prospective evaluation will validate the constructed system in a further COPD patient cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with COPD | – | Device: Cough monitoringPatients with frequent exacerbations of COPD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with current diagnosis of COPD who have had at least 2 moderate exacerbations of their COPD within the last year
Key inclusion criteria (5 listed)
- • Clinical diagnosis of COPD using GOLD criteria.
Key exclusion criteria (3 listed)
- • Children < age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cough monitoringcontinuous recording of cough in patients sleeping area for 90-180 days | Device | patient with COPD |
Primary outcome
Acute exacerbation of COPD alert system performance
Time frame: 90-190 days
the ratio of successful alerts of acute exacerbations of COPD to false positive alerts.
3 secondary outcomes
number of successfull alerts of Acute exacerbations of COPD
Time frame: 90-180 days
Number of False positive alerts of Acute Exacerbation of COPD
Time frame: 90-180 days
correlation cough counts with questionnaire data
Time frame: 90-180 days
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 1 Aug 2025.
- Results publication: PubMed 21115606Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.
- Results publication: PubMed 23806051de Oliveira JC, de Carvalho Aguiar I, de Oliveira Beloto AC, Santos IR, Filho FS, Sampaio LM, Donner CF, Oliveira LV. Clinical significance in COPD patients followed in a real practice. Multidiscip Respir Med. 2013 Jun 28;8(1):43. doi: 10.1186/2049-6958-8-43.
- Results publication: PubMed 19017866Burgel PR, Nesme-Meyer P, Chanez P, Caillaud D, Carre P, Perez T, Roche N; Initiatives Bronchopneumopathie Chronique Obstructive (BPCO) Scientific Committee. Cough and sputum production are associated with frequent exacerbations and hospitalizations in COPD subjects. Chest. 2009 Apr;135(4):975-982. doi: 10.1378/chest.08-2062. Epub 2008 Nov 18.
- Results publication: PubMed 8630597Vestbo J, Prescott E, Lange P. Association of chronic mucus hypersecretion with FEV1 decline and chronic obstructive pulmonary disease morbidity. Copenhagen City Heart Study Group. Am J Respir Crit Care Med. 1996 May;153(5):1530-5. doi: 10.1164/ajrccm.153.5.8630597.
- Results publication: PubMed 16120227Ekberg-Aronsson M, Pehrsson K, Nilsson JA, Nilsson PM, Lofdahl CG. Mortality in GOLD stages of COPD and its dependence on symptoms of chronic bronchitis. Respir Res. 2005 Aug 25;6(1):98. doi: 10.1186/1465-9921-6-98.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cough and COPD, run by Hull University Teaching Hospitals NHS Trust 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 5 inclusion and 3 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 1 Aug 2025. 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?
Acute exacerbation of COPD alert system performance (time frame: 90-190 days). 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 NCT07098793, which also lists 5 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 1 Aug 2025.