Cough Frequency in Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT01405222|
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : December 17, 2013
|Condition or disease|
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|
|Actual Enrollment :||24 participants|
|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 Start Date :||January 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||July 2013|
Acute COPD exacerbation
Patients admitted in to hospital with an acute exacerbation of COPD
- Change in recorded cough counts/hr [ Time Frame: 5 days ]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
- compare cough/hr measured via Hull automated cough counter with that of Phillips 45 day cough monitor [ Time Frame: 45 days ]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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405222
|Redspiratory medicine, Clinical trials Unit, Castle Hill hospital|
|Cottingham, East Yorkshire, United Kingdom, HU16 5JQ|
|Principal Investigator:||Alyn H Morice, MD, MPhil||Hull and East Yorkshire Hospitals NHS Trust|