Cough Frequency in Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01405222
First received: July 28, 2011
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition
COPD Exacerbation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Hull and East Yorkshire Hospitals NHS Trust:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 24
Study Start Date: January 2012
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute COPD exacerbation
Patients admitted in to hospital with an acute exacerbation of COPD

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital admissions

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01405222

Locations
United Kingdom
Redspiratory medicine, Clinical trials Unit, Castle Hill hospital
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Philips Respironics
Investigators
Principal Investigator: Alyn H Morice, MD, MPhil Hull and East Yorkshire Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Prof A H Morice, Professor of Respiratory Medicine, Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01405222     History of Changes
Other Study ID Numbers: 25042011
Study First Received: July 28, 2011
Last Updated: December 16, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
exacerbation
COPD
Cough

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014