Condition category
Respiratory
Date applied
15/03/2010
Date assigned
18/05/2010
Last edited
18/05/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Erica Rutten

ORCID ID

Contact details

Centre for Integrated Rehabilitation of Organ Failure (CIRO)
P.O. Box 4080
Horn
6080 AB
Netherlands
ericarutten@ciro-horn.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3.2.09.049

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

Acronym

AGOPD

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

Observational

Secondary study design

Cross-section survey

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/10/2010

Overall trial end date

01/10/2014

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

600

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

01/10/2010

Recruitment end date

01/10/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

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

Sponsor information

Organisation

Dutch Asthma Foundation (Netherlands)

Sponsor details

P.O.Box 5
Leusden
3830 AA
Netherlands

Sponsor type

Research organisation

Website

http://www.astmafonds.nl

Funders

Funder type

Research organisation

Funder name

Dutch Asthma Foundation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes