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

Recruitment & Eligibility

Status: Recruiting

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 between 40-80 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)

Inclusion criteria subjects without COPD
• Age between 40-80 years
• Willing and able to comply with the study protocol
• Active or ex-smoker > 10 pack years
• No COPD diagnosis, based on absence of airflow obstruction (post-bronchodilator spirometry FEV1/ FVC with z-score < -1.64)
• FEV1 > 80%
• Diffusing capacity > 70%

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

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 (History or current) asthma diagnosis
o Current pregnancy

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunology: ILC1 cells, ILC2 cells, ratio ILC1/ILC2, cytokines, Th-subset profiles.

Secondary Outcome Measures

Name	Time	Method
• Pathophysiology: TLC, FRC, FVC, sVC, iVC, FEV1 pre/post, RV, CO-diffusion, metronome paced tachypnea (dynamic hyperinflation with reversibility), MIP (maximal inspiratory pressure), iOS (impulse oscillometry). Haematology parameters, lipid profile, BMI and FeNO<br>• Behavior: Move-monitor, quality of life, coping. (Questionnaires: CAT, MRC, CCQ, EQ-5D-5L, TASMAN, NL-PIH.)<br>• Inflammatory parameters: in blood CRP, TRAIL, IP-10, lipid profile, eosinophils and neutrophils (both in sputum and in blood).<br>• History of risk factors: host factors (genetic factor alfa 1 anti trypsin deficiency, congenital), tobacco smoke, smoke from home cooking and heating fuels, occupational dusts, vapours, fumes, gases and other chemicals. Living conditions (living nearby harbour or highway). Birthweight, respiratory infections as a child. Exacerbation rate.

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