Assessment of Risk in Chronic Airways Disease Evaluation

NCT ID: NCT01656421

Last Updated: 2019-05-03

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

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Recruitment Status

COMPLETED

Total Enrollment

767 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2019-04-30

Brief Summary

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Patients with chronic obstructive pulmonary disease (COPD) have an increased risk of cardiovascular disease,osteoporosis, muscle wasting and diabetes mellitus. Cardiovascular disease is a major cause of death in such patients and it may be related to excess stiffening of the walls of major arteries, such as the aorta, and it has been suggested to represent premature aging. However, there is little known of the development of these problems, which were previously considered to be due to smoking and which is now known not to be the only factor. The investigators will study a large group of patients with mild to very severe airflow obstruction based on the NICE 2010 classification of severity and a matched comparator group free of COPD. This study involves three assessments of the development of the complications of COPD over a five year period. The key measure will be the rate of change in the aortic wall stiffness, an accepted indicator of the risk of heart disease. Changes in wall stiffness will be related to the severity of lung disease; other known cardiovascular risk factors, such as high blood pressure, increased blood cholesterol and to cardiovascular events including heart attacks and death; and to the presence of other complications, such as osteoporosis, muscle wasting and diabetes mellitus. These measures will be analysed in the context of changes in bodywide inflammation and metabolic function and the changes in the rate of ageing. This increased knowledge of interacting factors in the complications of COPD is likely to lead to studies of treatments to avoid their development.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD

Patients with Chronic Obstructive Pulmonary Disease, including mild, moderate, severe and very severe airflow obstruction

No interventions assigned to this group

Comparators

Current or ex-smokers free from from Respiratory Disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Previously Proven COPD or at risk of developing COPD

Exclusion Criteria

* Pregnancy
* A history of malignancy in the last 5 years
* Unable to give informed consent or diagnosed dementia
* Renal or hepatic failure
* Active endocrine disorder eg., Addison's disease, hypothyroidism
* Any other disease identified as having an inflammatory or metabolic component, eg. rheumatoid disease
* Disorders affecting mobility, eg. Parkinson's disease, cerebrovascular accident.
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Cardiff Metropolitan University

OTHER

Sponsor Role collaborator

Cardiff University

OTHER

Sponsor Role lead

Responsible Party

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Nichola Gale

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barry J McDonnell, PhD BSc

Role: PRINCIPAL_INVESTIGATOR

Cardiff Metropolitan University

John R Cockcroft, MD, FRCP

Role: STUDY_CHAIR

Cardiff Metropolitan University

Locations

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Cardiff Metropolitan University

Cardiff, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Mohan D, Forman JR, Allinder M, McEniery CM, Bolton CE, Cockcroft JR, MacNee W, Fuld J, Marchong M, Gale NS, Fisk M, Nagarajan S, Cheriyan J, Lomas DA, Calverley PMA, Miller BE, Tal-Singer R, Wilkinson IB, Polkey MI; ERICA Consortium. Fibrinogen does not relate to cardiovascular or muscle manifestations in COPD: cross-sectional data from the ERICA study. Thorax. 2018 Dec;73(12):1182-1185. doi: 10.1136/thoraxjnl-2018-211556. Epub 2018 Apr 4.

Reference Type DERIVED
PMID: 29618495 (View on PubMed)

Gale NS, Albarrati AM, Munnery MM, Munnery IC, Irfan M, Bolton CE, Rambaran CN, Singer RM, Cockcroft JR, Shale DJ. Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE): Protocol and preliminary data. Chron Respir Dis. 2014 Nov;11(4):199-207. doi: 10.1177/1479972314546765. Epub 2014 Aug 26.

Reference Type DERIVED
PMID: 25159833 (View on PubMed)

Other Identifiers

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10/CAD/4972

Identifier Type: OTHER

Identifier Source: secondary_id

SPON 87610

Identifier Type: -

Identifier Source: org_study_id

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