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Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)

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.
 
ClinicalTrials.gov Identifier: NCT01656421
Recruitment Status : Completed
First Posted : August 3, 2012
Last Update Posted : May 3, 2019
Sponsor:
Collaborators:
GlaxoSmithKline
Cardiff Metropolitan University
Information provided by (Responsible Party):
Nichola Gale, Cardiff University

Brief Summary:
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.

Condition or disease
Chronic Obstructive Pulmonary Disease (COPD)

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Study Type : Observational
Actual Enrollment : 767 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)
Actual Study Start Date : May 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort
COPD
Patients with Chronic Obstructive Pulmonary Disease, including mild, moderate, severe and very severe airflow obstruction
Comparators
Current or ex-smokers free from from Respiratory Disease



Primary Outcome Measures :
  1. Aortic Pulse Wave Velocity (arterial stiffness) [ Time Frame: Baseline, 2 and 5 yrs ]
    Rate of change in aortic pulse wave velocity in patients with COPD over a period of 5 years and its relationship to cardiovascular morbidity and mortality.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT01656421


Locations
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United Kingdom
Cardiff Metropolitan University
Cardiff, United Kingdom, CF5 2YB.
Sponsors and Collaborators
Cardiff University
GlaxoSmithKline
Cardiff Metropolitan University
Investigators
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Principal Investigator: Barry J McDonnell, PhD BSc Cardiff Metropolitan University
Study Chair: John R Cockcroft, MD, FRCP Cardiff Metropolitan University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nichola Gale, Lecturer, Cardiff University
ClinicalTrials.gov Identifier: NCT01656421    
Other Study ID Numbers: SPON 87610
10/CAD/4972 ( Other Identifier: Cardiff & Vale UHB R&D Office )
First Posted: August 3, 2012    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases