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CompletedNCT01405222Updated Jul 15, 2019

Cough Frequency in Chronic Obstructive Pulmonary Disease

An observational study in COPD Exacerbation, sponsored by Hull University Teaching Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-15.

Sponsored by Hull University Teaching Hospitals NHS Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COPD Exacerbation

Keywords

  • exacerbation
  • COPD
  • Cough
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 24 is below the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Hull University Teaching Hospitals NHS Trust is the lead sponsor of 93 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (actual)

Groups and cohorts

  • Acute COPD exacerbation

    Patients admitted in to hospital with an acute exacerbation of COPD

06

What researchers measure

Primary outcomes

  1. Change in recorded cough counts/hr

    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

    Time frame: 5 days

Secondary outcomes

  1. compare cough/hr measured via Hull automated cough counter with that of Phillips 45 day cough monitor

    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

    Time frame: 45 days

07

Study locations

1 site
  • Redspiratory medicine, Clinical trials Unit, Castle Hill hospital
    Cottingham, East Yorkshire HU16 5JQ, United Kingdom
08

References and documents

Publications

  • 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. PubMed 28353117 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01405222
Lead sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
Philips Respironics
Responsible party
Sponsor
First posted
Jul 29, 2011
Start date
Jan 2012
Primary completion
Jun 2013
Completion
Jul 2013
Last update
Jul 15, 2019

Study contacts

Alyn H Morice, MD, MPhil
principal investigator · Hull University Teaching Hospitals NHS Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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