General Risk factors And iNflammatory Determinants in younger PAtients with copd: the GRANDPA study

Completed

Conditions: COPD
emphysema
10024967

Registration Number: NL-OMON52605

Lead Sponsor: Franciscus Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1a. Cross sectional design To compare the differences in number of<br /><br>inflammatory cells (eosinophils, neutrophils, ILC1 cells, ILC2 cells and<br /><br>cytokines) in blood and sputum in COPD patients and controls during stable<br /><br>disease.<br /><br>1b. Longitudinal study design To compare the differences in number of<br /><br>inflammatory cells (leucocyte differentiation, ILC1 cells, ILC2 cells and<br /><br>cytokines) in blood during stable disease and exacerbation in COPD patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>2a. Cross sectional study design To measure physiological factors (lung<br /><br>function, activity level) and relate them to inflammatory profile.<br /><br>2b. Cross sectional study design To study the effect of aging on inflammation,<br /><br>physiology, psychology, quality of life and co- morbidities in COPD. </p><br>