Clinical trial NCT01405222: Cough Frequency in Chronic Obstructive Pulmonary Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD Exacerbation
Keywords: exacerbation
COPD
Cough
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Philips Respironics
First posted: 2011-07-29
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital admissions

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in recorded cough counts/hr
timeFrame: 5 days
Secondary outcomes:
measure: compare cough/hr measured via Hull automated cough counter with that of Phillips 45 day cough monitor
timeFrame: 45 days
Other outcomes:
Locations:
city: Cottingham
country: United Kingdom
facility: Redspiratory medicine, Clinical trials Unit, Castle Hill hospital
state: East Yorkshire
Study officials:
affiliation: Hull University Teaching Hospitals NHS Trust
name: Alyn H Morice, MD, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.