Assessment of Risk in Chronic Airways Disease Evaluation

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— ARCADE  

Official title:

Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656421
• Other study ID #: SPON 87610
• Secondary ID: 10/CAD/4972
• Status: Completed
• Start date: May 2011
• Est. completion date: April 2019

Study information

• Verified date: May 2019
• Source: Cardiff University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 767
• Est. completion date: April 2019
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	Cardiff Metropolitan University	Cardiff

Sponsors (3)

Lead Sponsor	Collaborator
Cardiff University	Cardiff Metropolitan University, GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic Pulse Wave Velocity (arterial stiffness)	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.	Baseline, 2 and 5 yrs