Cough Frequency in Chronic Obstructive Pulmonary Disease
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 28, 2011 | ||||||||
| Last Updated Date | October 16, 2012 | ||||||||
| Start Date ICMJE | January 2012 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in recorded cough counts/hr [ Time Frame: 5 days ] [ Designated as safety issue: No ] 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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01405222 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
compare cough/hr measured via Hull automated cough counter with that of Phillips 45 day cough monitor [ Time Frame: 45 days ] [ Designated as safety issue: No ] 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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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cough Frequency in Chronic Obstructive Pulmonary Disease | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Hospital admissions |
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| Condition ICMJE | COPD Exacerbation | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Acute COPD exacerbation
Patients admitted in to hospital with an acute exacerbation of COPD |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | August 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 40 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01405222 | ||||||||
| Other Study ID Numbers ICMJE | 25042011 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust | ||||||||
| Study Sponsor ICMJE | Hull and East Yorkshire Hospitals NHS Trust | ||||||||
| Collaborators ICMJE | Philips Respironics | ||||||||
| Investigators ICMJE |
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| Information Provided By | Hull and East Yorkshire Hospitals NHS Trust | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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