The main objective of the current study is to search for biomarkers, which will be investigated with their predictive value with respect to the course of COPD in lungfunction, exacerbations, health care use and mortality. The effects of the…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Biomarkers in the blood, a range of approximately 20 parameters, there will be
a search for predicting factors on exacerbation frequency and mortality on the
long term and for the effect of the lung rehabilitation on these biomarkers on
the short term. The number of exacerbations will be recorded.
Secondary outcome
Investigating the number of exacerbations, hospitalisations, progression of
COPD, mortality, health care use, quality of life over a long term follow-up
period.
Searching for correlations between biomarkers in blood and bonde density,
muscle quality and peripheral vasculature quality. Studying the effects of
rehabilitation program on muscle quality.
Background summary
COPD (Chronic Obstrcutive Pulmonary Disease) is a smoking related disease with
an increasing incidence and a great burden of illness.
Besides the lungs and airways other organs are affected, such as bloodvessels,
muscles and bones, in line with a systemische inflammation, existing besides
the locale inflammation.
At this moment there are no good predicting factors for the course of COPD.
Part of the COPD patients shows a slow gradual decline of among others
lungfunction, but a larger proportion of the patients present themselfes with a
rapid decline and with frequent exacerbations, necessitating hospitalisations.
The costs of severe COPD are not well-investigated yet and will be studied in
this investigation and compared to those in mild COPD and in healthy ccontrol
subjects.
Study objective
The main objective of the current study is to search for biomarkers, which will
be investigated with their predictive value with respect to the course of COPD
in lungfunction, exacerbations, health care use and mortality. The effects of
the rehabilitation program on the biomarkers will also be investigated.
Three groups of persons will be followed ( after an extended initial
investigation) after inclusion for 5 years: een group of approximately 220
patients with severe COPD (who are already participating in a 8 - 14 weeks lung
rehabilitaion program), a group of 40 patients with mild COPD and a group of 50
healthy control subjects.
Study design
Observational study, every three months in a telephone call lasting
approximately 30 minutes they will be asked extensively after their health, use
of medicines and health care use.
At the start of the study extensive tests are perforemd, among others for lung
function, bone density, the condition of peripheral vasculature status and th
edistance which can be walked in 6 minutes. Those test will be repeated at the
end of the 2 years follow-up.
The patients with mild COPD and the healthy control subjects wil be subjected
to a part of the assessments in the severe COPD patients.
After 2 years fo follow up, only survival status will be evaluated yearly for
another 3 years.
Study burden and risks
The burden for severe COPD patients is the series of extra tests, besides those
they already were exposed to during thier lung rehabilitation, an extra
investigation at the end of 2 years follow-up and conducting telephone calls
every three months. A bone densitometry will be made, peripheral blood
vasculature will be investigated and (optionally) investigations are done on
muscle.
For mild COPD patients and the healthy control subjects the burden consists of
a small extra number of tests besides those already performed when the patients
participated in the BOLD study in the previous period and the telephone calls.
In a subgroup of 20 patients with severe COPD and 20 healthy control subjects
an additional muscle biopsy will be obtained.
Pepparedsleden 1
Molndal SE-431 83
SE
Pepparedsleden 1
Molndal SE-431 83
SE
Listed location countries
Age
Inclusion criteria
Severe COPD: 1: referred to the CIRO in Horn for a lung rehabiliation program 2: agreeing to participate and signed "informed consent", 3: age 40 - 80 year, 4: lungfunction (post-bronchodilator FEV1) below 80% of predicted, 5: ratio FEV1 / FVC (post-bronchodilator) below 0.70, 6: current or ex-smoker with at least 10 pack-years
Healthy control subjects: 1: agreeing yto participate and signed "informed consent" , 2; age 40 - 80 years, 3: healthy, 4: lungfunction (post-bronchodilator FEV1) above 85% of predicted, 5: Ratio FEV1 / FVC (post bronchodilator) above 85% of predicted, 6: non-smoker or ex-smoker with less than 10 pack-years.
Mild COPD: 1: agreeing to particpate and signed "informed consent" , 2: COPD diagnosis confirmed in the BOLD project.
Exclusion criteria
All participants: history of asthma, other lung disease, severe cardiac disease, rheumatoid arthritis, bone disease, other concomitant disease, malignancy, pregnancy, physical handicap making walking impossible, alcohol or drug abuse, recent blood donation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17373.040.07 |