Cough Frequency in Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405222
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : December 17, 2013
Philips Respironics
Information provided by (Responsible Party):
Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust

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.

Condition or disease
COPD Exacerbation

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.

Study Type : Observational
Actual Enrollment : 24 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Acute COPD exacerbation
Patients admitted in to hospital with an acute exacerbation of COPD

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital admissions

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01405222

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
Principal Investigator: Alyn H Morice, MD, MPhil Hull and East Yorkshire Hospitals NHS Trust

Responsible Party: Prof A H Morice, Professor of Respiratory Medicine, Hull and East Yorkshire Hospitals NHS Trust Identifier: NCT01405222     History of Changes
Other Study ID Numbers: 25042011
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust:

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