Cough Frequency in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405222
• Other study ID #: 25042011
• Status: Completed
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	Redspiratory medicine, Clinical trials Unit, Castle Hill hospital	Cottingham	East Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust	Philips Respironics

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Publication Link