NCT01405222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

July 28, 2011

Last Update Submit

July 11, 2019

Conditions

Keywords

exacerbationCOPDCough

Outcome Measures

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

    5 days

Secondary Outcomes (1)

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

    45 days

Study Arms (1)

Acute COPD exacerbation

Patients admitted in to hospital with an acute exacerbation of COPD

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital admissions

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus.
  • On long-term oxygen therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Redspiratory medicine, Clinical trials Unit, Castle Hill hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCough

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Alyn H Morice, MD, MPhil

    Hull University Teaching Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2011

First Posted

July 29, 2011

Study Start

January 1, 2012

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations