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Autoimmunity in Chronic Obstructive Pulmonary Disease

Completed
Conditions
chronic bronchitis
COPD
emphysema
10027665
10024967
Registration Number
NL-OMON35095
Lead Sponsor
niversitair Medisch Centrum Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

COPD patients:
• Clinical diagnosis of COPD
• No allergies
• Post-bronchodilator FEV1 < 80% predicted, and postbronchodilator FEV1/FVC<70%
• Age > 40
• Current or ex-smokers > 10 pack years
• Ex-smokers have to have quitted smoking for at least one year
• No other major current health problems
• Written informed consent;Healthy controls:
• No signs of pulmonary disease
• No allergies
• No other major current health problems
• FEV1 > 90 % predicted and FEV1/FVC > 70%
• Age > 40
• Never smokers, i.e. no cigarettes last year, and < 5 pack years, or current smokers > 10 pack years; or ex- smokers for > 1 year and > 10 pack years
• Written informed consent

Exclusion Criteria

• Addiction to alcohol or drugs
• COPD exacerbation in the 6 weeks preceding the study

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The degree of autoantibody-mediated cytotoxicity of sera of COPD patients when<br /><br>compared to non-COPD patients, expressed as a fraction of cells that have died<br /><br>during incubation.<br /><br><br /><br>The cell types (primary bronchial epithelial cells, primary airway smooth<br /><br>muscle cells, primary lung fibroblasts) and cell lines (an alveolar epithelial<br /><br>cell line and a lung fibroblast cell line) that are primarily affected by<br /><br>autoantibodies as found in serum of COPD patients and healthy controls<br /><br><br /><br>The contribution of complement, different effector cells, and antibody-free<br /><br>serum to the level (as outlined in the previous paragraphs) and specificity of<br /><br>cytotoxicity (which cells and cell lines are affected). The impact of different<br /><br>effector cells and antibody-free serum.<br /><br></p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Effects of age, aspects of smoking history, clinical and immunological<br /><br>parameters on cytotoxicity<br /><br><br /><br>Insight into the components which play a role in lung remodelling and<br /><br>destruction. We expect that results will lead to more attention for COPD and<br /><br>more focus on relevant targets in drug development programs.<br /><br><br /><br>A better understanding of the mechanisms underlying the pathological changes in<br /><br>lungs of patients with COPD, and identification of characteristics of patients<br /><br>which may benefit from anti-autoimmune therapy. This is necessary to be able to<br /><br>develop more targeted drug development programs and to develop efficient<br /><br>therapies.<br /><br><br /><br>Due to the similarities of COPD to other autoimmune disease (outlined above),<br /><br>opportunities for improved treatment and medication may in part be based on<br /><br>regimes used in other autoimmune diseases. </p><br>
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