Cough Monitoring in COPD

NCT07098793 | Completed

• 1 other identifier: COPD2023
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cough; COPD; COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• Acute exacerbation of COPD alert system performance

  the ratio of successful alerts of acute exacerbations of COPD to false positive alerts.

  90-190 days

Secondary Outcomes (3)

• number of successfull alerts of Acute exacerbations of COPD

  90-180 days

• Number of False positive alerts of Acute Exacerbation of COPD

  90-180 days

• correlation cough counts with questionnaire data

  90-180 days

Study Arms (1)

patient with COPD

Patients with frequent exacerbations of COPD

Device: Cough monitoring

Interventions

Cough monitoring DEVICE

continuous recording of cough in patients sleeping area for 90-180 days

patient with COPD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with current diagnosis of COPD who have had at least 2 moderate exacerbations of their COPD within the last year

You may qualify if:

• Clinical diagnosis of COPD using GOLD criteria.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• Philips Electronics Nederland B.V. acting through Philips CTO organization: collaborator

Study Sites (1)

Redspiratory mMedicine, First Floor, Daisy Building, Castle Hill Hospital

Cottingham, East Yorkshiure, HU16 5JQ, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 21115606 RESULT

• de 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.

  PMID: 23806051 RESULT

• Burgel 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.

  PMID: 19017866 RESULT

• Vestbo 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.

  PMID: 8630597 RESULT

• Ekberg-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.

  PMID: 16120227 RESULT

MeSH Terms

Conditions

Cough; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: August 1, 2025
• Study Start: May 18, 2022
• Primary Completion: June 19, 2024
• Study Completion: October 10, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-03

Locations

GB (1)