Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease (copd)
Sponsor Cardiff University
Collaborator GlaxoSmithKline
Start date May 2011
End date December 2015
Trial size 750 participants
Trial identifier NCT01656421, 10/CAD/4972, SPON 87610

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with Chronic Obstructive Pulmonary Disease, including mild, moderate, severe and very severe airflow obstruction
Current or ex-smokers free from from Respiratory Disease

Primary Outcomes

Measure
Aortic Pulse Wave Velocity (arterial stiffness)
time frame: Baseline, 2 and 5 yrs

Eligibility Criteria

Male or female participants from 35 years up to 80 years old.

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.

Additional Information

Official title Assessment of Risk in Chronic Airways Disease Evaluation (ARCADE)
Principal investigator Dennis J Shale, MD, FRCP
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Cardiff University.