Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
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).
COPD is ranked number 3 by the WHO list of important diseases worldwide and is the only
disease with increasing mortality. The pathogenesis of cigarette smoke-induced COPD is
obscure, therefore more insight is needed to design effective anti-inflammatory agents.
Recently it has become clear that cigarette smoke-induced inflammation is not only present
in the lungs but also in the blood, and that this systemic inflammation has important
consequences for the clinical expression of COPD. The investigators hypothesize that healthy
individuals who are susceptible to cigarette smoking demonstrate a higher and aberrant
systemic inflammatory response to cigarette smoke. This susceptibility is caused by
heterogeneous factors and is associated with various polymorphic genes that interact with
each other and with the environment.
Objective:
- To study systemic inflammation in individuals who are or are not susceptible to develop
COPD.
- To characterize the switch to chronicity of the systemic inflmmatory response in COPD
- To determine whether the type and severity of the systemic inflammation contributes to
the clinical outcome of COPD
- To compare between subjects who are or are not susceptible to develop COPD in
peripheral blood, the corticosteroid responsiveness in vitro, and to unravel underlying
mechanisms.
- To study the role of candidate genes that may play a role in the development of fixed
airway obstruction, and to identify clues for patient's responsiveness to specific
drugs
- To develop new biological and clinical markers for the early diagnosis and monitoring
of COPD
- To define possible mediators involved in the early induction of COPD in susceptible
smokers, and to define new drug targets
Status | Recruiting |
Enrollment | 240 |
Est. completion date | January 2015 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: Age =18 and =75 years - Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of the 9 groups of the study population - Physically and mentally able to undergo the total study protocol - Written informed consent Exclusion Criteria: - Participation in another study - Alpha-1-antitrypsin deficiency - Selected grade 1-3 co-morbidity listed in the ACE-27 - 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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Top Institute Pharma | Academisch Ziekenhuis Maastricht, GlaxoSmithKline, Nycomed, UMC Utrecht, University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systemic inflammation assessed by measurement of expression of established and newly developed markers on innate immune cells; genomic and proteomic analysis of innate immune cells and measurement of pro- and anti-inflammatory cytokines in plasma/serum | 4 years | No | |
Secondary | Extensive clinical characterisation of: a) young healthy individuals with low number of pack years who have a high and low familial risk to develop COPD; b) older individuals with higher number of pack years with either a normal lung function or COPD. | 4 years | No | |
Secondary | Important clinical endpoints include symptoms, lung function, Bode-index, CT-scanning of the lung. | 4 years | No | |
Secondary | Distribution of candidate genes (SNPs) for COPD between the different groups and relations with systemic inflammation. | 4 years | No |
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