No registrations found.
ID
Source
Health condition
Chronic Obstructive Pulmonary Disease, COPD, Autoimmunity, lung, smoking, cytotoxicity, antibodies
Chronische Obstructieve Bronchitis en Longemfyseem, autoimmuniteit, long, roken, cytotoxiciteit, antilichamen
Sponsors and support
Hanzeplein 1
Postbus 30.001
9700 RB Groningen
The Netherlands
Intervention
Outcome measures
Primary outcome
1. The degree of autoantibody-mediated cytotoxicity of sera of COPD patients when compared to non-COPD patients, expressed as a fraction of cells that have died during incubation;
2. The cell types (primary bronchial epithelial cells, primary airway smooth muscle cells, primary lung fibroblasts) and cell lines (an alveolar epithelial cell line and a lung fibroblast cell line) that are primarily affected by autoantibodies as found in serum of COPD patients and healthy controls;
3. The contribution of complement, different effector cells, and antibody-free serum to the level (as outlined in the previous paragraphs) and specificity of cytotoxicity (which cells and cell lines are affected). The impact of different effector cells and antibody-free serum.
Secondary outcome
1. Effects of age, aspects of smoking history, clinical and immunological parameters on cytotoxicity;
2. Insight into the components which play a role in lung remodelling and destruction. We expect that results will lead to more attention for COPD and more focus on relevant targets in drug development programs;
3. A better understanding of the mechanisms underlying the pathological changes in lungs of patients with COPD, and identification of characteristics of patients which may benefit from anti-autoimmune therapy. This is necessary to be able to develop more targeted drug development programs and to develop efficient therapies;
4. Due to the similarities of COPD to other autoimmune disease (outlined above), opportunities for improved treatment and medication may in part be based on regimes used in other autoimmune diseases.
Background summary
N/A
Study objective
Chronic Obstructive Pulmonary Disease is a disease of the lungs for which adequate treatment lacks. We hypothesize that there is a role for autoimmunity in this disease.
Study design
N/A
Intervention
N/A
Inclusion criteria
Inclusion criteria for COPD patients:
1. Clinical diagnose of COPD;
2. No allergies;
3. Post-bronchodilator FEV1 < 80% predicted, and postbronchodilator FEV1/FVC < 70% (in accordance with the GOLD stages mentioned above);
4. Age > 40;
5. Current or ex-smokers > 10 pack years;
6. Ex-smokers have to have quitted smoking for at least one year;
7. No other major current health problems;
8. Written informed consent.
Healthy controls:
1. No signs of pulmonary disease;
2. No allergies;
3. No other major current health problems;
4. FEV1 > 90 % predicted and FEV1/FVC > 70%;
5. Age > 40;
6. 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;
7. Written informed consent.
Exclusion criteria
1. Addiction to alcohol or drugs;
2. COPD exacerbation in the 6 weeks preceding the study;
3. Immunosuppressive therapy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2135 |
| NTR-old | NTR2259 |
| Other | Dutch Asthma Foundation : 3.2.08.021 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |