Cough Frequency in Chronic Obstructive Pulmonary Disease

Objective Measure of COPD Exacerbation Using the Hull Automated Cough Recorder. Verifying Use of Automated Recording Systems in Measuring Symptoms Associated With a COPD Exacerbation

Acute exacerbations of COPD remain a common cause of morbidity and are associated with a sustained increase in the normal respiratory symptoms of dyspnoea, cough, and sputum volume and purulence. It has previously been shown that a change in cough symptoms occurs in 51.7% of exacerbations in COPD. We wish to record cough during a COPD exacerbation to determine whether this can be a objective marker of exacerbation duration and severity.

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation

Detailed Description

Acute exacerbations of COPD remain a common cause of morbidity and are associated with a sustained increase in the respiratory symptoms of dyspnoea, cough, sputum volume and sputum purulence. Cough is one of the most commonly reported and key symptoms in COPD patients. Cough can also be a useful factor in finding patients at risk of progressive airflow obstruction and cough along with the breathlessness is the major cause of distress in patients with chronic obstructive airways disease (COPD). There is limited literature looking into cough and COPD especially objective assessments.

in clinical practice and in most clinical trials scoring systems ie quality of life questionnaires or visual analogue scores, have been used to measure COPD exacerbation severity, although these may give an indication of the perceived severity of the symptom, they are inherently subjective and may be influenced by other factors. Shortfalls have prompted the development of cough recorders as an objective measure of this symptom. With this in mind we propose recruit 30 subjects with non-infective exacerbations of COPD and monitor their cough frequency as an inpatient in acute exacerbation and for 45 days post hospital discharge in order to elucidate the natural history of cough during and after an exacerbation.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United Kingdom
  • East Yorkshire
    • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
      • Redspiratory medicine, Clinical trials Unit, Castle Hill hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospital admissions

Description

Inclusion Criteria:

• Male/females aged between 40-80 years.
• Previous diagnosis of COPD.
• Acute exacerbation of COPD requiring treatment with antibiotics and/or corticosteroids.
• Symptoms of increased breathlessness, cough, sputum volume or sputum purulence.
• Acute exacerbation of COPD hospitalised within 48 hrs of study participation.
• On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion.
• Known history of cigarette smoking at least 10 pack yrs.
• Willing and able to comply with study procedures.
• Able to provide written informed consent to participate.

Exclusion Criteria:

• Acute exacerbation of COPD within 8 weeks prior to inclusion.
• Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus.
• On long-term oxygen therapy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Acute COPD exacerbation; Patients admitted in to hospital with an acute exacerbation of COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in recorded cough counts/hr	The primary objective is to evaluate the effectiveness of Hull Automated Cough Counter in recording transition of an acute COPD exacerbation. Change in no coughs/hr will be measured between start of exacerbation (day 0) to day 5 of exacerbation	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare cough/hr measured via Hull automated cough counter with that of Phillips 45 day cough monitor	The Key secondary endpoint will be to validate automated cough counts measured via the HACC with those measured via the Phillips 45CM at day 1, 5, 20 and 45. Cough monitor results will be compared using a bland altman plot, to determine if the systems are comparative with on another	45 days

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust
• Collaborators: Philips Respironics
• Investigators: Principal Investigator: Alyn H Morice, MD, MPhil, Hull University Teaching Hospitals NHS Trust

Publications and helpful links

General Publications

• Crooks MG, den Brinker A, Hayman Y, Williamson JD, Innes A, Wright CE, Hill P, Morice AH. Continuous Cough Monitoring Using Ambient Sound Recording During Convalescence from a COPD Exacerbation. Lung. 2017 Jun;195(3):289-294. doi: 10.1007/s00408-017-9996-2. Epub 2017 Mar 28.

Helpful Links

• Publication Link

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (Estimate): July 29, 2011

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: COPD; exacerbation; Cough
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 25042011