Acute and Chronic inflammatory responses induced by smoking in individuals being susceptible and non-susceptible for development of COPD: from specific disease phenotyping towards novel therapy (study 2).

Acute and Chronic inflammatory responses induced by smoking in individuals being susceptible and non-susceptible for development of COPD: from specific disease phenotyping towards novel therapy (study 2). - Systemic inflammation in COPD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32401

Enrollment

300

Registered

2008-12-12

Start date

2019-07-22

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic obstructive bronchitis (COPD) emphysema

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *Age *18 and *75 years *Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 9 groups of table 4.1 (see protocol ) *Physically and mentally able to undergo the total study protocol *Written informed consent

Exclusion criteria

Exclusion criteria: *Participation in another study * Alpha-1-antitrypsin deficiency * Selected grade 1-3 co-morbidity listed in the ACE-27 (areas marked red) * Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis * Active extra-pulmonary infection like hepatitis A-C, cystitis, gastro-enteritis etc *Pulmonary diseases like sarcoidosis, pulmonary fibrosis, silicosis, hypersensitivity pneumonitis, asthma *Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukaemia etc *Medication that may affect the results of the study: NSAID*s, immunosuppressive agents like prednisolon, metotrexate, azathioprine

Design outcomes

Primary

Measure	Time frame
* Extensive clinical characterisation of individuals who are: a) young healthy individuals with low number of pack years smoking who have a high and low familial risk to develop COPD; b) older individuals with higher number of pack years and who either have normal lung function or COPD. * Important clinical endpoints include symptoms, lung function, Bode-index, CT-scanning of the lung. * Systemic inflammation measured at three levels: 1. expression of established and newly developed markers on innate immune cells associated with pre-activation, 2. genomic and proteomic analysis of innate immune cells activated by cytokines in vitro and during inflammatory episodes in vivo; 3. multiplex analysis of the presence of pro- and anti-inflammatory cytokines in plasma/serum correlated with pre-activation of inflammatory cells in the same samples. * Distribution of candidate genes (SNPs) for COPD between the 9 different groups and relations with systemic inflammation.	—

Measure

Time frame

* Extensive clinical characterisation of individuals who are: a) young healthy individuals with low number of pack years smoking who have a high and low familial risk to develop COPD; b) older individuals with higher number of pack years and who either have normal lung function or COPD. * Important clinical endpoints include symptoms, lung function, Bode-index, CT-scanning of the lung. * Systemic inflammation measured at three levels: 1. expression of established and newly developed markers on innate immune cells associated with pre-activation, 2. genomic and proteomic analysis of innate immune cells activated by cytokines in vitro and during inflammatory episodes in vivo; 3. multiplex analysis of the presence of pro- and anti-inflammatory cytokines in plasma/serum correlated with pre-activation of inflammatory cells in the same samples. * Distribution of candidate genes (SNPs) for COPD between the 9 different groups and relations with systemic inflammation.

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Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results