To compare young and old COPD immunologically, physiologically, risk factors, patient behaviour and quality of life.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1a. Cross sectional design To compare the differences in number of
inflammatory cells (eosinophils, neutrophils, ILC1 cells, ILC2 cells and
cytokines) in blood and sputum in COPD patients and controls during stable
disease.
1b. Longitudinal study design To compare the differences in number of
inflammatory cells (leucocyte differentiation, ILC1 cells, ILC2 cells and
cytokines) in blood during stable disease and exacerbation in COPD patients.
Secondary outcome
2a. Cross sectional study design To measure physiological factors (lung
function, activity level) and relate them to inflammatory profile.
2b. Cross sectional study design To study the effect of aging on inflammation,
physiology, psychology, quality of life and co- morbidities in COPD.
Background summary
Chronic Obstructive Pulmonary Disease (COPD) is a chronic lung disease
characterized by persistent symptoms of inflammation and non-reversible airway
obstruction. It is associated with small airways disease and/or parenchymal
destruction (emphysema). The high mortality rate makes it the fourth leading
cause of death. The global prevalence of COPD is 11.7% (1). Inhalation of
cigarette smoke plays an important part in inducing COPD. The disease presents
mostly after the age of 40, due to the cumulative effects of smoking. Around
25% of the COPD patients is younger than 60 and 36% is younger than 65 years
(2). COPD patients under the age of 60 are seen as young patients. The impact
of COPD on daily life and work participation is high, especially in young
patients. Furthermore, little is known about the phenotype of young COPD
patients.
This resulted in the following research questions:
1. What is the difference in number of inflammatory cells (eosinophils,
neutrophils, ILC1 cells, ILC2 cells and cytokines) in blood and sputum of
different subgroups of COPD (young and old) during stable disease as well as in
a period of exacerbation?
2. Can we relate physiological factors (lung function and activity level) to
the inflammatory profile?
3. What*s the effect of aging on inflammation, physiology, quality of life and
co-morbidities in COPD?
Study objective
To compare young and old COPD immunologically, physiologically, risk factors,
patient behaviour and quality of life.
Study design
A part of the study is a cross-sectional study in which we will compare
patients with COPD. Healthy controls serve as comparison per age group.
The primary outcome is difference in number of ILC2 cells in blood between the
COPD patients and controls. Another part of the study is a longitudinal design
in which we compare ILC1 and ILC2 in stable disease and during exacerbation in
COPD patients.
Sputum, blood, physiological and clinical data will be collected during stable
disease and during exacerbation. The number of cells, morphology, and
activation status will be studied in various immune cells.
Study burden and risks
No personal benefit from participation in the GRANDPA study is expected. The
study comprises two scheduled visits. The first visit is already standard
practice. Most procedures are non-invasive (e.g. spirometry, use of
move-monitor, symptom score and quality of life assessment, cardiography). Two
procedures are more invasive and may be cause discomfort for the patient.
First, one blood sample will be taken (100 ml) and second, sputum induction
will be performed. This is regarded as a safe procedure and may cause
temporarily dyspnea and cough. The results from this study could be beneficial
for the patient population.
Kleiweg 500
Rotterdam 3045PM
NL
Kleiweg 500
Rotterdam 3045PM
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
Inclusion criteria subjects with COPD
• Age 40+ years
• COPD gold II-IV; FEV 1< 80%
• Active or ex-smoker > 10 pack years
• Willing and able to comply with the study protocol
• COPD diagnosis is based on presence of airflow obstruction
(post-bronchodilator spirometry FEV1/ FVC with z-score < -1.64)
Exclusion criteria
• Not full comprehensive in the Dutch language.
• A liaison with the coordinating or principal investigator, which could likely
influence the decision to participate in this study voluntarily (in concordance
with the WMO - article 5)
• Other diseases which could influence pulmonary function and/or the immune
system such as:
o A possible infection of the upper- or lower respiratory tract 6 weeks prior
to the collection of materials;
o Active malignancy
o Lung cancer diagnosis (also in the past)
o Asthma as the predominant disease according to the investigator's opinion, a
past history of asthma is allowed.
o Current pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70290.100.19 |
| Other | NL8286 (Netherlands Trial Registry) |
| OMON | NL-OMON26068 |