Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Erica Rutten


Contact details

Centre for Integrated Rehabilitation of Organ Failure (CIRO)
P.O. Box 4080
6080 AB

Additional identifiers

EudraCT number number

Protocol/serial number

Study information

Scientific title

Systemic manifestation and co-morbidity in chronic obstructive pulmonary disease (COPD) are associated with circulating markers of aging: a cross-sectional observational study with a longitudinal follow-up for two years



Study hypothesis

We hypothesise that accelerated aging is a key pathophysiological mechanism of chronic obstructive pulmonary disease (COPD), and that aging markers are related to important domains of the disease, particularly to the systemic phenotype of COPD and the clinically manifested co-morbidity.

Ethics approval

Maastricht Medical Etical Commission, pending as of 16/03/2010

Study design

Cross-sectional observational study with a longitudinal follow-up

Primary study design


Secondary study design

Cross-section survey

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Chronic obstructive pulmonary disease (COPD)


At baseline and 2 years later, the participants will be invited for two test days; one day at the Center of Expertise for Chronic Organ Failure (CIRO), Horn, and one day at the Maastricht University Medical Center (MUMC).

For COPD patients, the test days will be planned before the start of the rehabilitation. The first day and after overnight fast, venous blood of about 30 ml venous blood in total will be collected, an amount which is not of clinical relevance, but the venepuncture can cause a blue spot. The electrocardiography and the pulse wave velocity will also be performed in the fasted state. During this procedure, the arm will be occluded for 5 minutes. This may give a tingling feeling, but this feeling disappears when the occlusion is removed. Dual x-ray absorptiometry scan will be performed after emptying the bladder and a lung function measurement will take place after consuming breakfast. On the second day at the MUMC, all subjects will be invited for a high resolution computed tomography (HRCT) scan of the thorax.

During the follow-up of 2 years, medical status of the participants will be followed by a telephone contact every three months. For the COPD patients, lung function measurement and dual energy x-ray absorptiometry (DEXA) scan will be performed during the assessment of the rehabilitation at baseline. These tests do not have to be repeated. In a subgroup of 25 patients with the emphysema like phenotype, 25 patients with the non-emphysema like phenotype and 50 smoking healthy controls, circulating concentration of hepatokines and deoxyribonucleic acid (DNA) repair mechanism will be detected in a second venous blood sample during the second test day.

Intervention type



Not Applicable

Drug names

Primary outcome measure

All analysed at baseline:
1. Markers of aging
2. Objective diagnosed co-morbidity
3. Circulating hepatokines

Secondary outcome measures

All analysed at baseline:
1. Markers of systemic inflammation and oxidative stress
2. Classic characterisation of COPD

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

COPD patients:
1. Diagnosis of COPD according to the American Thoracic Society (ATS) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (forced expiratory volume in one second [FEV1] less than 80% predicted and FEV1/forced vital capacity [FVC] less than 70% and less than 10% predicted improvement in FEV1 after ƒÒ2-agonist inhalation
2. Both male and female, aged from 50 to 75 years
3. No respiratory tract infection or exacerbation of the disease for less than 4 weeks before the study
4. Capable of providing informed consent

Healthy subjects:
1. Healthy subjects as judged by a physician
2. Without diagnosed COPD or any other described co-morbidity/chronic disease
3. Both male and female, aged from 50 to 75 years

Participant type


Age group




Target number of participants


Participant exclusion criteria

COPD patients:
1. Any kind of carcinogenic pathology less than 5 years before study participation
2. Participation in any other studies involving investigational or marketed products concomitantly or less than 4 weeks prior to entry into the study

Healthy subjects:
1. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
2. Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Centre for Integrated Rehabilitation of Organ Failure (CIRO)
6080 AB

Sponsor information


Dutch Asthma Foundation (Netherlands)

Sponsor details

P.O.Box 5
3830 AA

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Dutch Asthma Foundation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes