Cough Frequency in Chronic Obstructive Pulmonary Disease

NCT ID: NCT01405222

Last Updated: 2019-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD Exacerbation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acute COPD exacerbation

Patients admitted in to hospital with an acute exacerbation of COPD

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Philips Respironics

INDUSTRY

Sponsor Role collaborator

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alyn H Morice, MD, MPhil

Role: PRINCIPAL_INVESTIGATOR

Hull University Teaching Hospitals NHS Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Redspiratory medicine, Clinical trials Unit, Castle Hill hospital

Cottingham, East Yorkshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 28353117 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

25042011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

COPD in the Time of COVID-19
NCT04407598 UNKNOWN